Cross Education Effect of Balance Program in Patients With Ankle Instability

July 15, 2020 updated by: Nadia Magdy Amen Elsotohy, Cairo University

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

Completed

Intervention / Treatment

Detailed Description

Thirty five females with Chronic Ankle Instability will be recruited from the Faculty of Physical Therapy, Cairo University by announcements to participate in this study. They will be randomly assigned into three groups; (A) Cross Education (balance training for the non affected side )(n=10), (B) Traditional training(balance training for the affected side) (n=10), (C) control group (no intervention) (n=15). stability indices measured by the Biodex Balance system , Single Leg Stance Test and scores of Star Excursion Balance Test will be assesssed before and after six weeks of Single Leg Balance training.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Faculty of physical therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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:

  1. - A history of previous surgeries or fractures in either limb of the lower extremities.
  2. - 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.
  3. - Balance deficits due to vestibular disorders, such as vertebrabasilar insufficiency and/or visual disorders.
  4. - Neuropathies and diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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).
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).
No Intervention: control
balance of 15 females with Chronic Ankle Instability will be assessed before and after six weeks of no intervention

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
The maximum distance the patient is able to reach in the Anterior direction during standing on one leg measured by centimeter
6 weeks
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
The maximum distance the patient is able to reach in the Posteromedial direction during standing on one leg measured by centimeter
6 weeks
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
The maximum distance the patient is able to reach in the Posterolateral direction during standing on one leg measured by centimeter
6 weeks
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
The mean of the anterior,Posteromedial and Posterolateral reach distances will be divided by the three times the limb lenght of the each patient
6 weeks
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
The Medio-lateral Stability Index (MLSI) assess the fluctuations from the horizontal along Medio-Lateral (ML) axis of the Biodex Balance System
6 weeks
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
The Antero-posterior Stability Index (APSI) assess the fluctuations from the horizontal along the Antero-Posterior (AP) axis of the BBS
6 weeks
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
The Overall Stability Index (OASI) is a composite of the Antero-posterior Stability Index (APSI) and the Medio-lateral Stability Index (MLSI)
6 weeks
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
The time during which the patient is able to stand on one leg measured by seconds
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nadia Ma Elsotohy, Dr, Dr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2019

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

August 20, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Cross Education of balance

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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