TRAIN-BW: Backward Walking Training in Multiple Sclerosis

Not Applicable

Recruiting

• Conditions: Gait Disorders, Neurologic; Accidental Fall; Multiple Sclerosis
• Interventions: Behavioral: Forward Walking Training; Behavioral: Backward Walking Training

• Registration Number: NCT04091464
• Lead Sponsor: Wayne State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-16
• Study Start: 2020-01-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12
• Primary Completion: 2025-01-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRAIN-FW	Forward Walking Training	1x/week for 8 weeks + home exercise program
TRAIN-BW	Backward Walking Training	1x/week for 8 weeks + home exercise program

Primary Outcome Measures

Name	Time	Method
Sway during quiet stance	Change in sway at 8 weeks	Measured with APDM Sensors
Stepping latency on push-and-release test	Change in stepping latency at 8 weeks	Measured with APDM Sensors

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wayne State University; 🇺🇸 Detroit, Michigan, United States