The Effect of Backward Walking Training on Balance, Gait and Functional Mobility in Patients With Multiple Sclerosis

Not Applicable

• Conditions: Multiple Sclerosis
• Interventions: Other: Exercise training

• Registration Number: NCT05505383
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

Backward walking training can be a useful treatment approach, providing novel balance and gait challenges. It can lead to improve balance, gait and functional mobility in neurologic populations. However, the effect of backward walking training has net been investigated in people with multiple sclerosis.

Detailed Description

Multiple sclerosis is a chronic autoimmune disease of the central nervous system. Patients with multiple sclerosis have problems in balance, gait, and functional mobility. This problems can lead to falls, injuries, hospitalization, limited daily living activities, and decreased quality of life. Backward walking is a popular training approach to improve balance, gait, and functional mobility in other neurological disease such as stroke, and Parkinson's disease. Moreover, backward walking performance decreases in multiple sclerosis. However, no study has been performed to determine the effectiveness of backward walking training in multiple sclerosis. Therefore, this study aimed to investigate the effect of backward walking training on balance, gait, and functional mobility in patients with multiple sclerosis.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-17
• Study Start: 2022-08-18
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-24
• Primary Completion: 2022-11-20
• Study Completion: 2022-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• at least 18 years,
• neurologist-diagnosed Multiple Sclerosis,
• Expanded Disability Status Scale (EDSS) score between 0 and 5.5,
• no MS exacerbation within the last 3 months,
• use of stable medication in the last 3 months,
• not received immunomodulator treatment within the last 6 months,

Exclusion Criteria

• other neurologic disorder,
• Pregnancy,
• Cardiovascular, orthopedic, or systemic any disease hindering the participation of exercise program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Backward walking training group	Exercise training	This group will participate in a backward walking training program (8-week, 3 times weekly, and 30-min each time) and conventional gait training program (8-week, 3 times weekly, and 45-min each time).
Conventional gait training	Exercise training	This group will participate in a conventional gait training program (8-week, 3 times weekly, and 45-min each time).

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale [Time Frame: 10 minutes]	10 minutes	Functional balance is assessed by using the Berg Balance Scale. During the test, participants are asked to perform 14 tasks frequently used in daily life activities. Each item is scored between 0 (unable to perform the task) and 4 (task is performed independently) according to the ability of the person while performing the task. The highest possible score is 56 points. A higher score indicates better balance.
Four Square Step Test	15 seconds	The Four Square Step Test measures dynamic balance and clinically assesses the person's ability to step over objects forward, sideways, and backward. A square was formed by 4 canes resting flat on the floor. The participants were instructed to try and complete the sequence as fast as possible without touching the canes with both feet, making contact with the floor in each square.
Activities-specific Balance Confidence Scale	2 minutes	Participants are asked to rate their balance confidence level 0% and 100% in the 16-item related to various everyday activities. The mean score on the 16-item questionnaire ranges from 0 to 100% and higher scores indicate a better balance confidence.
Six Minute Walk Test	6 minutes	It is used to measure gait performance. Participants are instructed to walk as far as they could over 6 min. The total distance that a people can walk was measured in meters.
3-meter Backward Walk Test	10 seconds	The 3-m course was determined and marked with black tape on the tile or wood surface. The test was started by asking participants to stand straight facing backward and to position their heels at the baseline level of the black tape. The examiner instructed the participants to walk backward rapidly, but as safely as possible. This test was performed with 3 trials, and the average time was expressed in seconds.
Multiple Sclerosis Walking Scale-12	2 minutes	The Multiple Sclerosis Walking Scale-12 is a 12-item patient-rated measure of the impact of multiple sclerosis on walking. Each item is rated on a scale ranging between 1 (Not at all) and 5 (Extremely). The total MSWS-12 score is computed by subtracting the minimum possible score of 12 points from the participant's score (i.e., sum of the 12 item scores), dividing by the maximal score of 60 points, and then multiplying the result by 100. This lead to a possible range of MSWS-12 scores between 0 and 80.
Timed 25-feet Walk Test	1 minutes	People with multiple sclerosis are instructed to walk 25 feet as fast, but safely, as possible. This test is timed from the moment the patient crossed the start line and stopped when people with multiple sclerosis is crossed the finish line.
Dynamic Gait Index	5 minutes	This test is designed to test eight facets of gait, including gait on even surface, gait with changing speed, gait with head turns in vertical and horizontal planes, stepping over or around obstacles, gait with pivot turns, and stair ascent and descent. It is scored a four-point ordinal scale, ranging from 0 to 3. The best possible score on the dynamic gait index is a 24.
Timed Up and Go Test	15 seconds	TUG is used to assess functional mobility. Participants are given verbal instruction to stand up from an armchair, walk forward 3 m, turn round, walk back towards the armchair and sit down. The time taken to complete is recorded.
10 Meter Walk Test	20 seconds	The 10-Meter Walk Test is a commonly used measure for assessing walking speed. For the 10 Meter Walk Test, two end lines and two buffer lines were taped on the ground. Each end line was 14 m from the other and the each buffer line was 2 m from the end line. The time to walk the middle 10 m was recorded using a stopwatch.

Trial Locations

Locations (1)

Ankara University; 🇹🇷 Ankara, Turkey