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Cross Education Effect of Balance Program in Patients With Ankle Instability

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ClinicalTrials.gov Identifier: NCT04072965
Recruitment Status : Active, not recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Nadia Magdy Amen Elsotohy, Cairo University

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Balance Ankle Instability Other: balance training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: group (A) Cross Education group(B) Traditional training group (C) control
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cross Education Effect of Balance Program in Patients With Ankle Instability
Actual Study Start Date : June 23, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : January 30, 2020

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
Other: balance training
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
Other: balance training
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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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. 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

  7. 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)

  8. 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



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072965


Locations
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Egypt
Faculty of physical therapy
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Nadia Ma Elsotohy, Dr Dr

Publications:
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Responsible Party: Nadia Magdy Amen Elsotohy, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT04072965     History of Changes
Other Study ID Numbers: Cross Education of balance
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Instability
Joint Diseases
Musculoskeletal Diseases