Proximal and Distal Therapeutic Approach in Pain and Lower Limb Kinematic in People With Patellofemoral Osteoarthritis

Comparison of Immediate Effects of a Proximal and Distal Therapeutic Approach in Pain and Lower Limb Kinematic During Functional Tasks in People With Patellofemoral Osteoarthritis: A Crossover Study

This is a crossover study that will investigate the immediate effects of a proximal therapeutic approach (SERF strap) and a distal one (foot orthoses) on knee pain intensity, global change, symptoms, ease of performance and confidence after each task and lower limb kinematics (hip adduction and internal hip rotation peak, rearfoor eversion peak) during functional taks (level-ground walking and stepping manoeuvres) in people with patellofemoral ostheoartritis

Study Overview

• Status: Not yet recruiting
• Conditions: Patellofemoral Osteoarthritis
• Intervention / Treatment: Device: Elastic hip strap; Device: Insole

Detailed Description

It will be enroled in this study 30 participants with patellofemoral ostheoartritis. The participants will be assessed during level walking at a self-selected speed and the stepping manoeuvre test under the three conditions that will be randomized: i) the control condition; ii) intervention proximal condition; and iii) intervention distal condition. The control condition refers to the condition in which no interventions will be administered. In both the intervention proximal condition and intervention distal condition, the respective therapeutic approach will be administered. For each functional task, three valid attempts will be collected. The primary outcome of this study is knee pain intensity and the secondary outcomes are both self-reported measures and kinematic variables measures. The self-reported measures are global change, symptoms, ease of performance and confidence, while the kinematic variables measures are hip adduction and internal hip rotation peak and rearfoor eversion peak

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Larissa R Souto, MSc; Phone Number: +55(18)988052128; Email: larissasouto@live.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Present anterior or retro patellar pain aggravated by two or more activities that overload the patellofemoral joint, such as going up and down stairs, squatting, remaining in the sitting position for long periods, getting up from the sitting position, kneeling or during physical exercise;
• Reporting pain of at least 3 on an 11-point scale (0 for no pain and 10 for the worst possible pain) during the activities described above and on most days during the last month;
• Have evidence of osteophyte formation in the patellofemoral joint on radiographs in the profile and axial skyline views through the Kellgren-Lawrence (K-L) grade ≥ 2, with minimal impairment in the tibiofemoral joint (KL <2);
• Body mass index (BMI) <35 Kg / m². Participants with unilateral or bilateral symptoms will be included in the study.

Exclusion Criteria:

• Current use or in the last 12 months of foot orthoses;
• Previous history of fracture or recurrent subluxation of the patella;
• Arthroscopic surgery or knee infiltrations in the last 3 months;
• Osteoarthritis known in other weight-bearing joints, including the spine;
• History of surgery on the hip, knee, ankle and foot joints;
• History of ankle sprain in the last 12 months;
• Osteotomy in the lower limbs;
• Current physical therapy in the lower limbs or in the last 6 weeks;
• Use of a cane or other walking aid;
• Any physical disability that is a contraindication for carrying out the evaluations and;
• Punctuation that suggests dementia according to the Mini-Mental State Examination, taking into account the education of the participants.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control condition; In this condition there will not be any application of therapeutic approach.
Experimental: Intervention proximal condition; The proximal therapeutic approach will be the SERF strap (S.E.R.F. strap; DonJoy Orthopedics, Inc., vista, CA).	Device: Elastic hip strap; The SERF Strap consist of a thin, elastic material that is secured to the proximal aspect of the leg, wraps in a spiral fashion around the thigh, and is anchored around the pelvis. The line of action of the SERF Strap pulls the hip into abdcution and external rotation.; Other Names: S.E.R.F. Strap; DonJoy Orthopedics, Inc, vista, CA
Experimental: Intervention distal condition; The distal therapeutic approach will be a pair of foot orthoses with semi-rigid arch support and medial elevation at the forefoot and at the rearfoot by 7° each (Propulsão Produtos Biomecânicos, Minas Gerais, Brazil).	Device: Insole; Foot orthoses with semi-rigid arch support and medial elevation at the forefoot and at the rearfoot by 7° each that is made from a block of ethyl vinyl acetate with a thermo-moldable polymer (shore hardness of 45 A) and is manufactured through an automated computer numeric control machine (CNC routers).; Other Names: Propulsão Produtos Biomecânicos, Minas Gerais, Brasil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Control Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the second valid attempt of the level-walking task in the Control Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Intervention Proximal Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the second valid attempt of the level-walkingtask in the Intervention Proximal Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Intervention Distal Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the second valid attempt of the level-walking task in the Intervention Distal Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Control Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Control Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Control Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Pain intensity	This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable	The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A global rating of change change (GRC) questionnaire	The GRC questionnaire is a 15 point self-report scale with criteria ranging from a 'very great deal worse' to a 'very great deal better.' The GRC is a valid and useful method for assessing the overall change in the quality of life of a person.	The GRC will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition
A global rating of change change (GRC) questionnaire	The GRC questionnaire is a 15 point self-report scale with criteria ranging from a 'very great deal worse' to a 'very great deal better.' The GRC is a valid and useful method for assessing the overall change in the quality of life of a person.	The GRC will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition
A global rating of change change (GRC) questionnaire	The GRC questionnaire is a 15 point self-report scale with criteria ranging from a 'very great deal worse' to a 'very great deal better.' The GRC is a valid and useful method for assessing the overall change in the quality of life of a person.	The GRC will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
A global rating of change change (GRC) questionnaire	The GRC questionnaire is a 15 point self-report scale with criteria ranging from a 'very great deal worse' to a 'very great deal better.' The GRC is a valid and useful method for assessing the overall change in the quality of life of a person.	The GRC will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Acceptable state of the patient's symptoms	The participants will answered this following question: "Considering your usual level of pain and also your functional impairment to perform tasks on a day-to-day basis, if you performed this functional task (gait or step-down test) with the application of this intervention (elastic band on the hip or foot orthosis) going forward, would you consider your current state to be satisfactory? " Participants will could answered "yes" or "no".	The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the level-walking tasks in the Intervention Proximal Condition
Acceptable state of the patient's symptoms	The participants will answered this following question: "Considering your usual level of pain and also your functional impairment to perform tasks on a day-to-day basis, if you performed this functional task (gait or step-down test) with the application of this intervention (elastic band on the hip or foot orthosis) going forward, would you consider your current state to be satisfactory? " Participants will could answered "yes" or "no".	The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the level-walking tasks in the Intervention Distal Condition
Acceptable state of the patient's symptoms	The participants will answered this following question: "Considering your usual level of pain and also your functional impairment to perform tasks on a day-to-day basis, if you performed this functional task (gait or step-down test) with the application of this intervention (elastic band on the hip or foot orthosis) going forward, would you consider your current state to be satisfactory? " Participants will could answered "yes" or "no".	The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Acceptable state of the patient's symptoms	The participants will answered this following question: "Considering your usual level of pain and also your functional impairment to perform tasks on a day-to-day basis, if you performed this functional task (gait or step-down test) with the application of this intervention (elastic band on the hip or foot orthosis) going forward, would you consider your current state to be satisfactory? " Participants will could answered "yes" or "no".	The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Ease of performing a task	Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)	The Ease of performing a task will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition
Ease of performing a task	Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)	The Ease of performing a task will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition
Ease of performing a task	Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)	The Ease of performing a task will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition
Ease of performing a task	Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)	The Ease of performing a task will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Control Condition
Ease of performing a task	Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)	The Ease of performing a task will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Ease of performing a task	Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)	The Ease of performing a task will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Knee confidence	The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).	The knee confidence will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition
Knee confidence	The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).	The knee confidence will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition
Knee confidence	The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).	The knee confidence will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition
Knee confidence	The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).	The knee confidence will assessed immediately after the third valid attempt of the stepping manoeuvre in the Control Condition
Knee confidence	The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).	The knee confidence will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Knee confidence	The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).	The knee confidence will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the first valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the gait of the second valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the third valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the first valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the second valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the third valid attempt in the Control Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the first valid attempt in the Control Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the second valid attempt in the Control Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the third valid attempt in the Control Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Proximal Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot of Eversion will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the first valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the second valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the third valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Adduction	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Adduction will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the first valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the second valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the third valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Hip Medial Rotation	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the first valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the second valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the third valid attempt of the stepping manoeuvre in the Control Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Lower limb kinematics - Peak of Rearfoot Eversion	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.	The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Publications and helpful links

General Publications

• Souto LR, Serrao PRMDS, Pisani GK, Tessarin BM, da Silva HF, Machado EM, de Oliveira Sato T, Serrao FV. Immediate effects of hip strap and foot orthoses on self-reported measures and lower limb kinematics during functional tasks in individuals with patellofemoral osteoarthritis: protocol for a randomised crossover clinical trial. Trials. 2022 Sep 5;23(1):746. doi: 10.1186/s13063-022-06676-0.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: February 16, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Gait; Quality of life; Knee osteoarthritis; Physiotherapy; Patellofemoral joint
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 2020/01599-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No