Effect of Backward Walking Versus Balance Training in Chronic Ankle Instability Patients

Not Applicable

Completed

• Conditions: Chronic Ankle Instability
• Interventions: Device: Balance Training; Other: Conventional treatment; Device: Backward Walking Training

• Registration Number: NCT05585385
• Lead Sponsor: Cairo University

Brief Summary

The goal of this clinical trial is to investigate the effect of backward walking versus balance training in patients with chronic ankle instability. The main question it aims to answer is:

Is there a difference between the effect of balance training and BW training on balance, ankle proprioception, risk of fall, and functional limitations in CAI patients?

Detailed Description

Lateral ankle sprains are among the most common musculoskeletal injuries. Approximately 40% of individuals who have ever suffered any lateral ankle sprain will develop chronic ankle instability which is defined as posterior mechanical and functional deficits in this joint.

Balance is the process that maintains the center of gravity within the body's support base, which needs constant adjustments with joint positioning and muscular activity. Many musculoskeletal and nervous system diseases can alter balance control. It has been reported that individuals with CAI have poor static and dynamic balance compared to those with normal ankles, and this affection of balance, increases the falling risks and leads to serious injuries.

A reversal of normal walking is simply recognized as retro-walking or backward walking (BW), where the toes first reach the ground and finish with the heel off. BW training causes changes in the motion control system and gait characteristics and exerts a positive effect on postural stability.

Sixty patients with chronic ankle instability will be assigned randomly into 3 equal groups; group A will receive BW training in addition to the traditional physical therapy program for 3 sessions/ week, over 6 weeks periods, Group B: will receive balance training on Biodex balance system in addition to the traditional physical therapy program for 3 sessions/ week, over 6 weeks periods, group C: will receive the traditional physical therapy program only for 3 sessions/ week, over 6 weeks periods.

Study Timeline

• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-18
• Study Start: 2022-11-02
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-25
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-16
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. All subjects will complete a questionnaire by self-report (Cumberland Ankle Instability Tool (CAIT) to be characterized as having Functional Ankle Instability (FAI) ; All subjects' scores on CAIT will be less than 23 to be severely identified with FAI. Subjects will satisfy the following criteria:

   Having FAI that persists after the initial lateral ankle sprain and complaining of residual symptoms (repeated episodes of giving way or feeling of ankle joint instability) and suffering of repeating injury.

2. Having mechanical ankle instability on one ankle joint (will be identified by manual testing as talar tilt and anterior drawer test of the ankle to determine the integrity of ankle ligaments).

3. Their age ranges from 18 to 35 years.

4. Subjects with body mass index less than 30 kg/m2.

5. Not undergoing any formal or informal rehabilitation of the unstable ankle.

Exclusion Criteria

1. Ankle joint swelling or any rheumatological disorders in both legs.
2. Ankle surgery in either leg.
3. Gross limitation in ankle range of motion in both legs.
4. Any joint disease or bony fracture in the lower extremity.
5. History of neurological disorder affecting the upper or lower extremities, vestibular dysfunction, or balance disorder.
6. Receiving formal or informal rehabilitation of their unstable ankle for 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balance Training	Balance Training	The patients will receive balance training on the Biodex balance system in addition to the traditional physical therapy program for 6 weeks.
conventional treatment	Conventional treatment	The patients will receive the traditional physical therapy program only for 6 weeks.
Backward Walking Training	Backward Walking Training	The patients will receive BW training in addition to the traditional physical therapy program for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Active repositioning accuracy of ankle joint	up to 6 weeks	Ankle proprioception will be assessed by a digital goniometer. The starting position for ankle joint testing is 90 degree. The maximum ankle planter flexion for each subject will be measured, and half this max. range will be selected as the target position. Subjects will be asked to remain in that position for 10 seconds. The subject with closed eyes actively moves the ankle from starting position (90 degrees) to the targeted plantar-flexion angle with constant speed during the test (they were asked to return to the initial position and progressively move towards the target degree). This process would be repeated 3 times and the average error in active repositioning of the targeted angle would be taken.
Dynamic Balance Assessment	up to 6 weeks	Dynamic balance is assessed by the Biodex stability system which has a high level of accuracy in determining dynamic equilibrium for postural control testing. It establishes three numeric stability indexes: Overall Stability Index (OSI), Anterior/Posterior Stability Index (APSI), and Medial/Lateral Stability Index (MLSI), to assess the body's deviation from its gravity center. The OSI indicates the overall score in all directions, while the APSI and MLSI represent the sagittal and frontal planes, respectively. The higher the stability, the lower the ranking.
Functional limitations	up to 6 weeks	Functional disability will be assessed by the Foot and Ankle Disability Index (FAID).This index is a 34-item questionnaire divided into subscales, FADI and FADI sport. FADI contains 4 pain related items and 22 activity related items, while the FADI sport contains 8 activity related items. Each question can be scored on a 5- point Likert scale (from 0 to four). FADI and FADI sport are scored separately. FADI has total score of 104 points and FADI Sport 32 points. Both are transformed into percentage.

Trial Locations

Locations (1)

Faculty of Physical Therapy, Cairo University; 🇪🇬 Giza, Egypt