NCT04072965

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

August 20, 2019

Last Update Submit

July 15, 2020

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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

    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

    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

    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

    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

    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

    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

    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

    The time during which the patient is able to stand on one leg measured by seconds

    6 weeks

Study Arms (3)

Cross eduacation of balance

EXPERIMENTAL

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

Other: balance training

Traditional training

EXPERIMENTAL

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

Other: balance training

control

NO INTERVENTION

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

Interventions

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).

Cross eduacation of balanceTraditional training

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 30192681BACKGROUND

Study Officials

  • Nadia Ma Elsotohy, Dr

    Dr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: group (A) Cross Education group(B) Traditional training group (C) control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 20, 2019

First Posted

August 28, 2019

Study Start

June 23, 2019

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

July 16, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations