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Cross Education Effect of Balance Program in Patients With Ankle Instability

Primary Purpose

Balance, Ankle Instability

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
balance training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Balance

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of physical therapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Cross eduacation of balance

Traditional training

control

Arm Description

10 females with Chronic Ankle Instability will receive balance training for the non affected side for a six weeks

10 females with Chronic Ankle Instability will receive balance training for the affected side for a six weeks

balance of 15 females with Chronic Ankle Instability will be assessed before and after six weeks of no intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 20, 2019
Last Updated
July 15, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04072965
Brief Title
Cross Education Effect of Balance Program in Patients With Ankle Instability
Official Title
Cross Education Effect of Balance Program in Patients With Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 23, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Balance, Ankle Instability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group (A) Cross Education group(B) Traditional training group (C) control
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cross eduacation of balance
Arm Type
Experimental
Arm Description
10 females with Chronic Ankle Instability will receive balance training for the non affected side for a six weeks
Arm Title
Traditional training
Arm Type
Experimental
Arm Description
10 females with Chronic Ankle Instability will receive balance training for the affected side for a six weeks
Arm Title
control
Arm Type
No Intervention
Arm Description
balance of 15 females with Chronic Ankle Instability will be assessed before and after six weeks of no intervention
Intervention Type
Other
Intervention Name(s)
balance training
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Description
The maximum distance the patient is able to reach in the Anterior direction during standing on one leg measured by centimeter
Time Frame
6 weeks
Title
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
Description
The maximum distance the patient is able to reach in the Posteromedial direction during standing on one leg measured by centimeter
Time Frame
6 weeks
Title
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
Description
The maximum distance the patient is able to reach in the Posterolateral direction during standing on one leg measured by centimeter
Time Frame
6 weeks
Title
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
Description
The mean of the anterior,Posteromedial and Posterolateral reach distances will be divided by the three times the limb lenght of the each patient
Time Frame
6 weeks
Title
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
Description
The Medio-lateral Stability Index (MLSI) assess the fluctuations from the horizontal along Medio-Lateral (ML) axis of the Biodex Balance System
Time Frame
6 weeks
Title
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
Description
The Antero-posterior Stability Index (APSI) assess the fluctuations from the horizontal along the Antero-Posterior (AP) axis of the BBS
Time Frame
6 weeks
Title
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
Description
The Overall Stability Index (OASI) is a composite of the Antero-posterior Stability Index (APSI) and the Medio-lateral Stability Index (MLSI)
Time Frame
6 weeks
Title
Assessing change in the time of Single Leg Stance Test between the initial assessment and after six weeks of single leg balance training
Description
The time during which the patient is able to stand on one leg measured by seconds
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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: - 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia Ma Elsotohy, Dr
Organizational Affiliation
Dr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of physical therapy
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30192681
Citation
Anguish B, Sandrey MA. Two 4-Week Balance-Training Programs for Chronic Ankle Instability. J Athl Train. 2018 Jul;53(7):662-671. doi: 10.4085/1062-6050-555-16.
Results Reference
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Learn more about this trial

Cross Education Effect of Balance Program in Patients With Ankle Instability

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