TRAIN-BW: Backward Walking Training in Multiple Sclerosis

Study Overview
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Brief Summary
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Individuals with multiple sclerosis (MS) experience in impairments in mobility and cognition that increase the risk for accidental falls. More than 50% of individuals with MS experience injurious falls within a 6-month period. Current interventions to improve fall risk have focused on forward walking (FW) and balance training, resulting in small declines in the relative risk for falls with a large degree of variability. Interestingly, motor differences between MS and healthy controls are more pronounced in backward walking (BW), yet no studies have investigated BW training as an intervention to reduce fall risk in persons with MS. This study will investigate the feasibility, acceptability and impact of BW training compared to forward walking training on motor function and fall risk in persons with MS.

Official Title
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TRAIN-BW: Backward Walking Training in Multiple Sclerosis

Conditions
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Multiple Sclerosis, Gait Disorders, Neurologic, Accidental Fall

Intervention / Treatment
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* Behavioral: Backward Walking Training
* Behavioral: Forward Walking Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of MS PDDS <6, indicating ability to ambulate with or without an assistive device >/= 50% of the time Self-reported walking dysfunction as evidenced by a score of >/= 30 on MSWS-12 OR reports of 2 or more falls in the prior 6 months, indicating a frequent faller. Exclusion Criteria: MS relapse within the past 30 days comorbid neurological disorder acute orthopedic disorder/injury unable to follow study-related commands

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRAIN-BW<br>1x/week for 8 weeks + home exercise program | Behavioral: Backward Walking Training<br>* Training will consist of BW training on both a treadmill and overground. All participants will receive 1x/week training with a trained member of the research team, who will progress the participant week-to-week and ensure safety. Treadmill speed will be determined by baseline BW walking speed and incrementally increased with each training week to subject tolerance. Participants will follow a home exercise program for the remainder of the week that includes BW, backward stepping, and functional exercises that incorporate BW movements.<br>|
| Active Comparator: TRAIN-FW<br>1x/week for 8 weeks + home exercise program | Behavioral: Forward Walking Training<br>* Training will consist of FW training on both treadmill and overground. All participants will receive 1x/week training with a trained member of the research team, who will progress the participant week-to-week and ensure safety. Treadmill speed will be determined by baseline FW walking speed and incrementally increased with each training week to subject tolerance. Participants will follow a home exercise program for the remainder of the week that includes FW, forward stepping, and functional exercises that incorporate FW movements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sway during quiet stance | Measured with APDM Sensors | Change in sway at 8 weeks | 
| Stepping latency on push-and-release test | Measured with APDM Sensors | Change in stepping latency at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Client Satisfaction Questionnaire (CSQ-8) | Scores range from 8-32, with high scores indicating greater satisfaction with the intervention | 8 weeks | 
| Patient Global Impression of Change | Perceived Treatment Effect; scores range from 1-7 with higher scores indicating greater perception of improvement related to the intervention. | 8 weeks | 
| Number of Active Minutes | Measured with Accelerometry, passively collected for a 1 week period prior to the intervention and again after the intervention concludes 8 weeks later. | Change in Physical Activity measures at 8 weeks | 
| Number of Falls | Number of falls reported in 6 month period after the intervention ends | 6 months | 
| Forward and Backward Velocity and Double Support Time | Walking speed and double support time (spatiotemporal measures of gait) | Change in velocity and double support time at 8 weeks | 
| ABC Scale | Balance confidence | Change in balance confidence at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Backward Walking, Neurorehabilitation