Strengthening Program for Foot-ankle Muscles in People With Knee Osteoarthritis

Effects of a Strengthening Program for Foot-ankle Muscles in Clinical Aspects and Gait Biomechanics of People With Knee Osteoarthritis: a Randomized Blinded Clinical Trial

The main objective of this trial is To evaluate the effect of an ankle and foot muscle strengthening program on pain, analgesic consumption, functionality, and lower limb biomechanics during gait in individuals with knee osteoarthritis.

Study Overview

• Status: Suspended
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Intervention Group

Detailed Description

A randomized controlled trial will be performed with 76 patients with knee osteoarthritis. The participants will be randomly assigned into either a control group (no exercises; they will keep their recommended clinical treatment) or an intervention group which will receive 8-week physical therapy exercises, three times per week, under the supervision of a physiotherapist. Every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty.

The subjects will be evaluated in 3 different moments (Baseline, immediately after treatment and 8 weeks follow-up).

The hypothesis of this study is that the intervention group will decrease pain and medication intake, and improve functional performance, increase isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group.

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São Carlos, São Paulo, Brazil
      • Glauko Dantas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Knee osteoarthritis (KOA) based on clinical and radiological criteria of American College of Reumathology;
• KOA (Grade II and III - Radiological classification of Kellgreen and Laurence) in medial compartment of knee;
• Knee pain between 30 and 80 on the visual analogue scale;
• BMI < 35 kg/m2.

Exclusion Criteria:

• KOA isolated (Grade II and III - Radiological classification of Kellgreen and Laurence) in lateral compartment of knee;
• Lower limb strength training (3 times per week);
• Wear minimalist shoes for at least 6 hours a day and 5 days a week;
• Physical therapy in the previous 3 months;
• Having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively;
• Previous history of surgery on knees, ankles and hips in the last 2 years;
• Neurological disease;
• Inflammatory arthritis (eg. rheumatoid arthritis);
• Asymptomatic OA of one or both knees.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Patients will receive a physical therapy intervention three times per week, for 8 weeks.	Other: Intervention Group; Patients will receive a physical therapy intervention for strengthening, stretching and functional training of ankle and foot.; Other Names: Foot and ankle kinesiotherapy
No Intervention: Control Group; Patients will not receive any exercise treatment but they will keep their recommended clinical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline The WOMAC (Western Ontario and McMaster Universities) Pain Subscale at 8 and 16 weeks.	The WOMAC pain subscale consists of five questions (Likert Scale) relating to the patient's pain in everyday situations. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of pain subscale ranges from 0 to 20. Higher scores indicate worse pain.	Baseline, 8 weeks and 16 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline WOMAC (Western Ontario and McMaster Universities) Stiffness Subscale at 8 and 16 weeks.	The stiffness subscale included in the WOMAC index consists of two questions (Likert Scale) relating articular function of the patient. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of the stiffness subscale ranges from 0 to 8. Higher scores on the stiffness WOMAC subscale indicate worse articular function.	Baseline, 8 weeks and 16 weeks.
Change from baseline WOMAC (Western Ontario and McMaster Universities) Physical Function Subscale at 8 and 16 weeks.	he physical function subscale included in the WOMAC index consists of seventeen questions (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of physical function subscale ranges from 0 to 68. Higher scores on the physical function WOMAC subscale indicate worse functional limitations.	Baseline, 8 weeks and 16 weeks.
Change from baseline WOMAC (Western Ontario and McMaster Universities) Total Score at 8 and 16 weeks	The WOMAC total score is the sum of all subscale (pain, function and stiffness) (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme.	Baseline, 8 weeks and 16 weeks.
30-second Chair Stand Test	The maximum number of chair stand repetitions possible in a 30 second period.	Baseline, 8 weeks and 16 weeks.
9-step Stair Climb Test	The time (in seconds) it takes to ascend and descend a flight of stairs. Where possible, the 9-step stair test with 20cm (8 inch) step height and handrail is recommended.	Baseline, 8 weeks and 16 weeks.
40m (4x10m) Fast Paced Walk Test	A test of walking speed over short distances and changing direction during walking. A fast-paced walking test that is timed over 4 x 10m for a total 40 m (convert time to speed).	Baseline, 8 weeks and 16 weeks.
Foot strength	Hallux and lesser toes force measured by a pressure plate	Baseline, 8 weeks and 16 weeks.
Foot Kinematics during gait	Foot joints and plantar arch motion during gait.The kinematics outcomes will be evaluate by mean inverse dynamics approach. To this procedure, we will use the kinematics data of the lower limbs assessed with six infrared cameras and the ground reaction force evaluated by mean a force platform.	Baseline, 8 weeks and 16 weeks.
Knee joint moments during gait	Peak joint moment by inverse dynamic calculations. To this procedure, we will use the kinematics and kinetics data of the lower limbs assessed with six infrared cameras and the ground reaction force evaluated by mean a force platform.	Baseline, 8 weeks and 16 weeks.
Global Rating of Change Scale	GRCS assesses the clinical change perceived by the patient by comparing the onset of symptoms before and after treatment. "With respect to your knee injury, how do you describe your situation now compared to the start of treatment?" This numerical scale consists of 11 points (from -5 to +5: -5, extremely worse; 0, unchanged; +5, fully recovered). Higher scores indicate better recovery from the condition.	8 weeks and 16 weeks.
Paracetamol intake	Paracetamol intake (500 mg), number of tablets per month.	Baseline, 8 weeks and 16 weeks.

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos
• Collaborators: University of Sao Paulo

Publications and helpful links

General Publications

• Dantas G, Sacco ICN, Dos Santos AF, Watari R, Matias AB, Serrao PRMS, Pott-Junior H, Salvini TF. Effects of a foot-ankle strengthening programme on clinical aspects and gait biomechanics in people with knee osteoarthritis: protocol for a randomised controlled trial. BMJ Open. 2020 Sep 25;10(9):e039279. doi: 10.1136/bmjopen-2020-039279.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Therapeutic exercises; Arthrosis; Feet
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: LabPlastUFSCar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data collected during the trial will be compiled electronically. Data integrity and validity will be verified at the time of data entry (edit checks). The project manager and research assistant will regularly monitor the study datasets and make recommendations regarding necessary protocol modifications or termination of all or part of the study. Participant data that underlie the results reported in this paper will be shared after blinding (text, tables, figures, appendices), immediately following publication. In addition, the study protocol and clinical trial report (both with the planned statistical analysis) will be made available by the researchers who proposed the methodology. Requests for data or any form of analysis should be directed to glauko.ft.andre@hotmail.com or tania@ufscar.br. Requesters will be asked to sign a data access agreement.
• IPD Sharing Time Frame: Participant data that underlie the results reported in this paper will be shared after blinding (text, tables, figures, appendices), immediately following publication.
• IPD Sharing Access Criteria: Requests for data or any form of analysis should be directed to glauko.ft.andre@hotmail.com or tania@ufscar.br. Requesters will be asked to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

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