- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04072965
Cross Education Effect of Balance Program in Patients With Ankle Instability
Researchers recommended that NeuroMuscularControl (NMC) training should not begin immediately after an acute Lateral Ankle Sprain(LAS) because of pain and weight-bearing restrictions. So, there is a need for an alternative way by which we can begin NMC retraining sooner. By training the non-affected ankle (Cross education), clinicians can begin NMC retraining before the individuals can bear weight on the affected ankle, in the acute stage of healing, or even if there is any other precautions or contraindications to exercise due to the injuries. Athletes with more chronic injuries may be able to perform NMC and functional retraining at higher levels than otherwise would be possible by initiating the training on the non affected ankle. Initiating these activities on the non-affected ankle will result in earlier improvements in postural control and function in the affected ankle.
By this way, the rehabilitation times will be short, athletes can return earlier to sport participation or work, health care costs will decrease. Up to the knowledge of the author, there is a gap in research investigating cross education effect of balance program in patients with ankle instability. So, the current study was conducted to reveal the role of this phenomena in such cases and add this phenomenon on the physical therapy field to manage patients with ankle instability (If Cross Education phenomena is effective, this phenomena will be used in rehabilitation).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Faculty of physical therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 1 ankle sprain, with the initial sprain occurring more than 1 year before the study
- A feeling of ''giving way'' (at least 2 episodes in the 6 months before the study).
- At least two ''yes'' answers on questions four to eight on the Modified Ankle Instability Instrument (MAII)
Exclusion Criteria:
- - A history of previous surgeries or fractures in either limb of the lower extremities.
- - Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous three months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least one interrupted day of desired physical activity.
- - Balance deficits due to vestibular disorders, such as vertebrabasilar insufficiency and/or visual disorders.
- - Neuropathies and diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cross eduacation of balance
10 females with Chronic Ankle Instability will receive balance training for the non affected side for a six weeks
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Thirty five females with CAI will be recruited from the Faculty of Physical Therapy, Cairo University by announcements to participate in this study.
The participants will be randomly assigned into three groups; (A) Cross Education will receive single leg balance training for the non affected side (n=10), (B) Traditional training will receive single leg balance training for the affected side (n=10), (C) control group will receive no intervention (n=15).
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Experimental: Traditional training
10 females with Chronic Ankle Instability will receive balance training for the affected side for a six weeks
|
Thirty five females with CAI will be recruited from the Faculty of Physical Therapy, Cairo University by announcements to participate in this study.
The participants will be randomly assigned into three groups; (A) Cross Education will receive single leg balance training for the non affected side (n=10), (B) Traditional training will receive single leg balance training for the affected side (n=10), (C) control group will receive no intervention (n=15).
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No Intervention: control
balance of 15 females with Chronic Ankle Instability will be assessed before and after six weeks of no intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing change in the Anterior reach distance of Star excursion balance test between the initial assessment and after six weeks of single leg balance training
Time Frame: 6 weeks
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The maximum distance the patient is able to reach in the Anterior direction during standing on one leg measured by centimeter
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6 weeks
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Assessing change in the Posteromedial reach distance of Star excursion balance test between the initial assessment and after six weeks of single leg balance training
Time Frame: 6 weeks
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The maximum distance the patient is able to reach in the Posteromedial direction during standing on one leg measured by centimeter
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6 weeks
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Assessing change in the Posterolateral reach distance of Star excursion balance test between the initial assessment and after six weeks of single leg balance training
Time Frame: 6 weeks
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The maximum distance the patient is able to reach in the Posterolateral direction during standing on one leg measured by centimeter
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6 weeks
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Assessing change in the Composite reach distance of Star excursion balance test between the initial assessment and after six weeks of single leg balance training
Time Frame: 6 weeks
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The mean of the anterior,Posteromedial and Posterolateral reach distances will be divided by the three times the limb lenght of the each patient
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6 weeks
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Assessing change in the Medio-lateral Stability Index (MLSI) measured by the Biodex Balance system between the initial assessment and after six weeks of single leg balance training
Time Frame: 6 weeks
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The Medio-lateral Stability Index (MLSI) assess the fluctuations from the horizontal along Medio-Lateral (ML) axis of the Biodex Balance System
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6 weeks
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Assessing change in the Antero-posterior Stability Index (APSI) measured by the Biodex Balance System between the initial assessment and after six weeks of single leg balance training
Time Frame: 6 weeks
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The Antero-posterior Stability Index (APSI) assess the fluctuations from the horizontal along the Antero-Posterior (AP) axis of the BBS
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6 weeks
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Assessing change in the Overall Stability Index (OASI) measured by the Biodex Balance system between the initial assessment and after six weeks of single leg balance training
Time Frame: 6 weeks
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The Overall Stability Index (OASI) is a composite of the Antero-posterior Stability Index (APSI) and the Medio-lateral Stability Index (MLSI)
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6 weeks
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Assessing change in the time of Single Leg Stance Test between the initial assessment and after six weeks of single leg balance training
Time Frame: 6 weeks
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The time during which the patient is able to stand on one leg measured by seconds
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nadia Ma Elsotohy, Dr, Dr
Publications and helpful links
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cross Education of balance
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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