- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04660604
Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique in Individuals With Asymptomatic Dynamic Knee Valgus
Investigation of the Functional and Biomechanical Effect of Instrument Assisted Soft Tissue Mobilization Technique in Individuals With Asymptomatic Dynamic Knee Valgus - Randomized Controlled Trial
STUDY DESIGN: Randomized controlled study OBJECTIVES: To investigate the contribution of instrument assisted soft tissue mobilization (IASTM) applied to gluteus medius (GMed) to isokinetic strength, femoral internal rotation (FIR), frontal plan projection angle (FPPA) and postural stability (PS) in individuals with asymptomatic dynamic knee valgus (DDV).
BACKGROUND: In the literature effect of IASTM on force production and performance has been examined with exercise, and results of the studies are contradictory. Studies investigating the effects of IASTM without exercise and at recommended dose are needed.
METHODS: 44 participants with DDV (21,39±1,79) were randomized to be control group (CG=22) and graston group (GG=22). First day, participants' FIR, FPPA with single leg squat test, dynamic and static PS on involved leg evaluations were completed. Second day, eccentric strength of GMed was measured by isokinetic test. IASTM application was applied 6 weeks, twice a week, 5 minutes, using Graston Technique® instruments. CG has not been attempted. Evaluations were repeated at the end of treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction Dynamic knee valgus (DDV), one of the lower extremity faulty movement patterns, is a biomechanical deviation that occurs in 3 motion plans, involving femoral internal rotation (FIR) and contralateral pelvis fall simultaneously with hip adduction.1 Hip flexion, adduction and FIR moments occur simultaneously during loading phase of walking, running or landing after jumping. Combination of these moments also forms DDV. These moments are resisted by intrinsic moments caused by eccentric contractions of hip extensor, abductor and external rotator muscles. Strength deficiency of these muscles in weight transfer activities causes an increase in hip adduction, and FIR, changes whole lower extremity kinematics.2,3 The valgus alignment also increases the risk of injury.4 In the review examining relationship between hip muscle strength and DDV, it was determined that decrease in gluteus medius (GMed) strength in functional activities on single leg was associated with DDV.2 Abduction torque produced by hip abductors stabilizes pelvis on relatively fixed femur by controlling pelvis in frontal and horizontal planes during stance phase of walking and most of stance and GMed produces most of the compression forces in hip.3,5 Therefore, GMed strength is also very important for postural stability (PS). In individuals with DDV, strength of hip muscles, especially GMed, should be focused on increasing PS during the tests performed on single leg and in injury prevention programs.4,6 Anatomical features of women increase the risk of DDV. In addition, when gender comparison was made, it was seen that women needed more eccentric contraction in the hip abductor muscles during the stance phase of running.7, and strength deficiency in proximal hip stabilizers of females could cause a greater decrease in athletic performance compared to men.8 Therefore, evaluation of eccentric strength of GMed muscle should be evaluated specific to gender.2 Thus, a more precise conclusion can be found in terms of abductor muscle strength, DDV and lower extremity alignment.
Effect of soft tissue mobilization techniques on force production and performance is a remarkable topic. Instrument-assisted soft tissue mobilization (IASTM) technique, one of the soft tissue mobilization techniques, has also been found to be effective method that affects muscle strength, performance and endurance through activation of muscle and nervous systems.9-11 However, in studies IASTM technique was applied with an exercise protocol, and contribution of IASTM in force generation and performance increase is not understood.
According to our knowledge, in the literature there is no randomized controlled study examining the effect of IASTM applied without exercise. Aim of our study is to investigate changes caused by IASTM applied to GMed muscle on eccentric force production of GMed, FIR, frontal plane projection angle (FPPA) and PS.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Besiktas/Istanbul
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İstanbul, Besiktas/Istanbul, Turkey, 34353
- Pelin Pişirici
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- to be a female between ages of 18 and 35,
- to have an increase of more than 10 ° in FPPA in landing phase of single leg squat test (SLST),
- not to have pain complaints
- to be recreatively active.
Exclusion Criteria:
- body mass index of 30 kg/m² and above,
- to have previous lower extremity surgery and joint,
- meniscus or ligament injury,
- chronic knee instability,
- leg length inequality,
- joint degeneration detected by radiography,
- cardiac, musculoskeletal system, vestibular and neurological problems,
- using corticosteroids for a long time
- being pregnant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Graston Technique® Group
Participants were asked to warm up at a speed that they felt comfortable for 5 minutes at a gentle tempo with an ergometer.
Time was followed by a stopwatch.
Participants who completed warm-up were taken to GT® application.
Application was implemented by a GT® certified therapist with 13 years of experience in orthopedic rehabilitation.
Intervention dosage was determined as 2 times a week, 12 sessions over 6 weeks.
GMed muscle was scanned between crista iliaca and trochanter major, and a fascial release was applied.
Each session lasted 5 minutes.
At the end of sessions, iliotibial band stretching exercises (30 seconds, 3 repetitions) was given to the treated side.
Application protocol has been determined with reference to GT® manual
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Graston technique, one of the soft tissue mobilization techniques, has also been found to be effective method that affects muscle strength, performance and endurance through activation of muscle and nervous systems.
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No Intervention: Control Group
Control group is followed up for 6 weeks without intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in isokinetic strength measurement
Time Frame: Pre evaluation before the intervention, 1 day after the intervention
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gluteus medius eccentric strength evaluated with Cybex® Norm isokinetic dynamometer
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Pre evaluation before the intervention, 1 day after the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in postural stability evaluation
Time Frame: Pre evaluation before the intervention, 1 day after the intervention
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static and dynamic single leg postural stability
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Pre evaluation before the intervention, 1 day after the intervention
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Change in Femoral internal rotation angle evaluation
Time Frame: Pre evaluation before the intervention, 1 day after the intervention
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Femoral internal rotation angle measurement
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Pre evaluation before the intervention, 1 day after the intervention
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Change in frontal plan projection angle evaluation
Time Frame: Pre evaluation before the intervention, 1 day after the intervention
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Frontal plan projection angle measurement in single leg squat test
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Pre evaluation before the intervention, 1 day after the intervention
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IASTM-24.11.20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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