- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07054788
- Original Trial
Effect of Kinesiotaping on Lower Limb Kinematics and Functional Related Outcomes Among Female Athletes With Chronic Lateral Ankle Instability
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mahmoud Abd Elaziz Abdelmoneim, physical therapist
- Phone Number: 01021247473
- Email: Mahmoudelnakeeb84@gmail.com
Study Locations
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Helwan, Egypt
- Faculty of Physical education for females, Helwan university
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Contact:
- Mahmoud Abdelaziz Abdelmoneim, physical therapist
- Phone Number: +201021247473
- Email: Mahmoudelnakeeb84@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18-24 years.
- chronic ankle instability group has a history of unilateral ankle inversion injury since at least one year before the study onset
- A period of restricted weight-bearing and/or immobilization for at least one day
- The patient reported a tendency to give way during functional activities
- Positive anterior drawer test and/or talar tilt test
- At least 2 giving-way episodes within 6 months before the study enrollment and/or recurrent ankle sprain
- Score of 24 on the Cumberland ankle instability tool
Exclusion Criteria:
- Acute ankle injuries within the past 3 months.
- Any other lower extremity injuries or surgeries that could affect balance or ankle function.
- Participation in either formal or informal rehabilitation before enrollment in the study
- Skin allergy from kinesiotaping.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise therapy with Kinesiology tape
This group involves fifty-five participants and will receive kinesiology tape with mobilization with movement and calf muscle flexibility exercises.
3 sessions per week for 2 weeks.
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Participants will perform calf muscle stretching exercises. The participant will be asked to keep the knee of the stretched leg straight with the heel flat on the ground, slightly bend the front knee, and push the hips toward a wall. The exercise will be done in 2 sets of 3 repetitions, every repetition for 30 seconds and a ten-second rest, with a one-minute rest between sets
The Mulligan mobilization techniques involve talar glide and fibular glide.
Talar glide involves manually stabilizing the patient's talus and leg with anteroposterior direction pressure, while fibular glide involves a pain-free sustained anterior to posterior, slightly superior, and lateral glide of the distal fibula.
The patient is then asked to plantar-flex, invert the foot, and perform overpressure.
The technique is performed during ankle dorsiflexion in a closed kinetic chain.
The length of tape is calculated using a formula: B = A + (XA ∗ 0.35), where "A" is the tape's length, "X" is the pretension, "0.35" is the 35% tension, and "B" is the muscle's length from origin to insertion.
In this study, 50% pretension was used, and "A" was added to the tails.
Fibular taping is applied immediately after the MWM to improve positional alignment, wrapping around the distal tibia and applying Mueller tape in the same direction.
Talar taping involves wrapping Mueller tape from the talus downward and posterior to the calcaneus while holding the ankle in slight dorsiflexion.
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Active Comparator: Exercise therapy with placebo tap
This group involves fifty-five participants and will receive mobilization with movement and calf muscle flexibility exercises and placebo tape.
3 sessions per week for 2 weeks.
|
Participants will perform calf muscle stretching exercises. The participant will be asked to keep the knee of the stretched leg straight with the heel flat on the ground, slightly bend the front knee, and push the hips toward a wall. The exercise will be done in 2 sets of 3 repetitions, every repetition for 30 seconds and a ten-second rest, with a one-minute rest between sets
The Mulligan mobilization techniques involve talar glide and fibular glide.
Talar glide involves manually stabilizing the patient's talus and leg with anteroposterior direction pressure, while fibular glide involves a pain-free sustained anterior to posterior, slightly superior, and lateral glide of the distal fibula.
The patient is then asked to plantar-flex, invert the foot, and perform overpressure.
The technique is performed during ankle dorsiflexion in a closed kinetic chain.
The formula for cutting tape length is B = A + (XA ∗ 0.35), where "A" represents the tape's length, "X" is the pretension, "0.35" is the 35% tension, and "B" is the muscle's length from origin to insertion.
In this study, 50% pretension was used, and "A" was added to the tails' length.
The tape application involves two steps: from below the medial calcaneus to the medial aspect of the lower leg, and from below the lateral malleolus to the lateral aspect.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of change of Dorsiflexion range of motion
Time Frame: at baseline and after 2 weeks
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The weight-bearing lunge test is a controlled exercise that involves standing upright facing a vertical wall with a measuring tape and a tape affixed to the wall.
Participants lunge forward, flexing at the ankle, knee, and hip on the test leg to make contact with the wall.
After a successful attempt, the foot is moved backward in 1 cm increments.
The distance between the heel and the wall and the anterosuperior edge of the patella is recorded to the nearest 0.1 cm.
Ankle dorsiflexion angle is calculated using the trigonometric function.
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at baseline and after 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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assessment of change of dynamic balance
Time Frame: at baseline and after 2 weeks
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The Y-balance test is a method to assess a person's dynamic balance by aiming to maintain single-leg balance while reaching as far as possible with the contralateral leg in three different directions.
The test involves three trials for each reach direction, with resting intervals to minimize fatigue.
To account for individual differences in limb length, reach distances are normalized to leg length.
This method standardizes performance measurements, allowing for more accurate comparisons of dynamic balance and mobility between individuals of varying anthropometric characteristics.
Normalization is essential in functional reach tasks to reduce bias and enhance the validity of inter-subject comparisons.
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at baseline and after 2 weeks
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assessment of change of single-leg squat performance
Time Frame: at baseline and after 2 weeks
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The Kinovea software is used to assess single leg squat performance in patients with chronic ankle instability, focusing on stability and alignment.
The patient's movements are captured using a high-resolution camera, ensuring clear view of lower extremities.
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at baseline and after 2 weeks
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assessment of change of ankle physical function
Time Frame: at baseline and after 2 weeks
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The Foot and Ankle Ability Measure (FAAM) Sports Subscale is a tool used to measure physical function.
It scores items from 4 to 0, with the highest potential score being the highest number of responses.
Higher scores indicate better physical function, and the total score is divided by the highest potential score.
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at baseline and after 2 weeks
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Collaborators and Investigators
Sponsor
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mahmoud-005551
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
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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