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

NCT ID: NCT05585385

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-02
• Study Completion Date: 2023-06-25

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.

Conditions

Chronic Ankle Instability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Backward Walking Training

The patients will receive BW training in addition to the traditional physical therapy program for 6 weeks.

Group Type: EXPERIMENTAL

Backward Walking Training

Intervention Type: DEVICE

The subjects in this group will receive BW training program on an electric treadmill. The subject will be asked to walk, arms beside, in a backward manner on a level treadmill, zero inclination, with a warming up and cooling down period (5 minutes for each period). The subject walks at his self-selected and comfortable walking speed. A warm-up and cool-down period, in form of light jogging on a treadmill, will be done at speed of 1-2 m/sec. The total training is 30 minutes, three times a week for six consecutive weeks.

Balance Training

The patients will receive balance training on the Biodex balance system in addition to the traditional physical therapy program for 6 weeks.

Group Type: EXPERIMENTAL

Balance Training

Intervention Type: DEVICE

Subjects in this group will receive balance training on Biodex Balance System for 3 sessions/ week, over 6 weeks period. Each subject will be instructed to stand with both legs on the "locked" platform. The researcher advances the platform to an unstable state while instructing the subject to focus on the visual feedback screen. Arms are free at the side of the body and not grasping handrails.

After selecting the stability training program (dynamic balance training), Stability levels are changed depending on the subject's ability to maintain balance, and subjects are instructed to maintain their Center of Pressure (COP) in the smallest concentric rings (balance zones) of the Biodex Balance System monitor, named A zone.

The stability level of the platform is set at level plate stability 8 (the most stable) for the first two sessions. After that, the plate stability is decreased by one level every two sessions to increase the difficulty in training.

conventional treatment

The patients will receive the traditional physical therapy program only for 6 weeks.

Group Type: ACTIVE_COMPARATOR

Conventional treatment

Intervention Type: OTHER

Patients in this group will receive the traditional physical therapy program only for 3 sessions/ week, over 6 weeks period. The traditional physical therapy program is (evertors strengthening, short foot ex, heel raise ex, and calf stretch).

Interventions

Backward Walking Training

The subjects in this group will receive BW training program on an electric treadmill. The subject will be asked to walk, arms beside, in a backward manner on a level treadmill, zero inclination, with a warming up and cooling down period (5 minutes for each period). The subject walks at his self-selected and comfortable walking speed. A warm-up and cool-down period, in form of light jogging on a treadmill, will be done at speed of 1-2 m/sec. The total training is 30 minutes, three times a week for six consecutive weeks.

Intervention Type: DEVICE

Balance Training

Subjects in this group will receive balance training on Biodex Balance System for 3 sessions/ week, over 6 weeks period. Each subject will be instructed to stand with both legs on the "locked" platform. The researcher advances the platform to an unstable state while instructing the subject to focus on the visual feedback screen. Arms are free at the side of the body and not grasping handrails.

After selecting the stability training program (dynamic balance training), Stability levels are changed depending on the subject's ability to maintain balance, and subjects are instructed to maintain their Center of Pressure (COP) in the smallest concentric rings (balance zones) of the Biodex Balance System monitor, named A zone.

The stability level of the platform is set at level plate stability 8 (the most stable) for the first two sessions. After that, the plate stability is decreased by one level every two sessions to increase the difficulty in training.

Intervention Type: DEVICE

Conventional treatment

Patients in this group will receive the traditional physical therapy program only for 3 sessions/ week, over 6 weeks period. The traditional physical therapy program is (evertors strengthening, short foot ex, heel raise ex, and calf stretch).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Heba Ahmed Ibrahim Ibrahim ElGayar

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neveen A. Abdel Raoof, PhD

Role: STUDY_CHAIR

Cairo University

Ghada A. Abd Allah, PhD

Role: STUDY_DIRECTOR

Cairo University

Rania R. Mohamed, PhD

Role: STUDY_DIRECTOR

Cairo University

Amr A. Azzam, PhD

Role: STUDY_DIRECTOR

National Institute of Neuromotor System

Locations

Faculty of Physical Therapy, Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/003911

Identifier Type: -

Identifier Source: org_study_id