- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07319403
Comparison of the Effects of Hip and Ankle Focused Progressive Exercise Training on Lower Extremity Function in Athletes With Chronic Ankle Instability
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic ankle instability is characterized by persistent mechanical and functional impairments that may develop following a lateral ankle sprain. Individuals with this condition commonly exhibit reduced proprioception, impaired neuromuscular control, limited dorsiflexion range of motion, and altered lower-extremity biomechanics, all of which may negatively affect daily activities and athletic performance. These deficits often lead to compensatory strategies at more proximal segments, and emerging evidence suggests that hip musculature plays a meaningful role in maintaining dynamic ankle stability. However, the specific contribution of individual hip muscle groups has not yet been clearly defined.
This study is designed to compare the effects of strengthening different hip muscle groups -the gluteus medius and gluteus maximus- on functional and neuromuscular outcomes in individuals with chronic ankle instability. Participants will be randomly assigned to one of three parallel groups: a gluteus medius strengthening group, a gluteus maximus strengthening group, or a control group performing standard balance exercises. Each intervention group will follow a structured and progressively loaded exercise program targeting the designated muscle group. All participants will complete supervised training sessions throughout the intervention period.
The study protocol includes a baseline assessment session, a multi-week intervention phase, and a post-intervention evaluation. Outcome measures will include functional performance tests, assessments of neuromuscular control, and metrics related to dynamic stability. These outcomes will be collected before and after the intervention to determine differences between groups.
The aim of this protocol is to determine whether targeted strengthening of specific hip muscle groups yields superior improvements in individuals with chronic ankle instability. The findings are expected to enhance understanding of the role of proximal musculature in lower-extremity stability and contribute to more precise and effective rehabilitation strategies for this population.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Çiğdem Demir
- Phone Number: +905444674810
- Email: fztcigdemdemir@gmail.com
Study Locations
-
-
Çankaya
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Ankara, Çankaya, Turkey (Türkiye)
- Hacettepe University
-
Contact:
- Çiğdem Demir
- Phone Number: 05444674810
- Email: fztcigdemdemir@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Professional athletes aged between 18 and 40 years
Participation in sports for at least 3 years
History of at least one lateral ankle sprain that occurred at least 12 months prior to enrollment
At least two episodes of perceived ankle "giving way" and/or at least two recurrent lateral ankle sprains within the past 6 months, and/or a subjective feeling of ankle instability on the injured side
Exclusion Criteria:
History of lower extremity surgery
History of fracture involving the lower extremity
Any lower extremity injury within the past 3 months that limited physical activity for more than one day
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gluteus Maximus
Participants with chronic ankle instability will participate in a 6-week hip-focused exercise program emphasizing gluteus maximus activation.
|
Participants with chronic ankle instability will participate in a 6-week hip-focused strengthening exercise program targeting the gluteus maximus muscle.
The program aims to enhance hip extension strength and overall lower extremity stability.
|
|
Experimental: Gluteus Medius
Participants with chronic ankle instability will participate in a 6-week hip-focused exercise program emphasizing gluteus medius activation.
|
Participants with chronic ankle instability will undergo a 6-week hip-focused strengthening exercise program specifically targeting the gluteus medius muscle.
The intervention aims to improve hip muscle strength and lower extremity stability.
|
|
Active Comparator: Control
Participants with chronic ankle instability will participate in a 6-week exercise program commonly used in the rehabilitation of ankle instability
|
Participants with chronic ankle instability will perform a 6-week standard strengthening exercise program commonly used in the rehabilitation of ankle instability, without specific emphasis on targeted hip muscle strengthening.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumberland Ankle Instability Tool (CAIT)
Time Frame: Baseline and after 6 weeks
|
The Cumberland Ankle Instability Tool (CAIT) is a self-reported questionnaire designed to assess the severity of chronic ankle instability.
It consists of 9 items evaluating ankle stability during daily and sports-related activities.
Scores range from 0 to 30, with lower scores indicating greater perceived ankle instability.
An increase in the CAIT score reflects clinical improvement in ankle stability.
|
Baseline and after 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Ankle Instability Questionnaire
Time Frame: Baseline and after 6 weeks
|
Self-reported functional ankle instability will be evaluated using the Functional Ankle Instability Questionnaire.
The questionnaire will be administered face-to-face by a trained physiotherapist to assess perceived ankle instability during daily and sports-related activities.
|
Baseline and after 6 weeks
|
|
Hip Muscle Strength
Time Frame: Baseline and after 6 weeks
|
Isometric hip abduction and hip extension muscle strength will be assessed using a handheld dynamometer (KForce Muscle Controller, KInvent, USA).
Hip abduction strength will be measured in a side-lying position at 25° of hip abduction with the knee extended, targeting the gluteus medius muscle.
Hip extension strength will be measured in a prone position with the knee flexed at 90°, targeting the gluteus maximus muscle.
Three trials will be performed bilaterally, and the mean value will be used for analysis.
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Baseline and after 6 weeks
|
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Side Hop Test
Time Frame: Baseline and after 6 weeks
|
Functional performance will be assessed using the Side Hop Test.
Participants will be instructed to perform repeated lateral hops on one leg over a single reference line as quickly as possible for 30 seconds.
The total number of successful hops will be recorded.
The test will be performed three times, and the highest value will be used for analysis.
|
Baseline and after 6 weeks
|
|
Step-Down Test
Time Frame: Baseline and after 6 weeks
|
Postural stability and lower extremity kinematics will be evaluated using the Step-Down Test.
Participants will stand on a raised platform on the test limb with hands placed on the waist and perform a controlled step-down by lowering the contralateral heel toward the ground and returning to the starting position.
The movement will be performed at a standardized pace.
The movement quality will be evaluated based on trunk, pelvis, and knee alignment.
|
Baseline and after 6 weeks
|
|
Y-Balance Test
Time Frame: Baseline and after 6 weeks
|
Dynamic balance will be assessed using the Y-Balance Test.
Participants will perform maximal reach distances in the anterior, posteromedial, and posterolateral directions while standing on the dominant limb.
Reach distances will be normalized to limb length.
The average of three trials in each direction will be used for analysis.
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Baseline and after 6 weeks
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Single-Leg Heel Raise Balance Test
Time Frame: Baseline and after 6 weeks
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Static balance will be assessed using the single-leg heel raise balance test.
Participants will stand on one leg and perform plantar flexion while maintaining balance.
The test will be terminated when the heel touches the ground.
The average duration of three trials will be recorded.
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Baseline and after 6 weeks
|
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Weight-Bearing Lunge Test
Time Frame: Baseline and after 6 weeks
|
Ankle dorsiflexion range of motion will be assessed using the weight-bearing lunge test.
Participants will lunge forward toward a wall while maintaining heel contact with the ground.
The maximum distance between the great toe and the wall will be measured.
Three trials will be performed for each limb, and the mean value will be used for analysis.
|
Baseline and after 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Irem DUZGUN, Hacettepe University
- Principal Investigator: Gülcan Harput, Ankara Medipol University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HU-FTR-ÇD-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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