TRAIN-BW: Backward Walking Training in Multiple Sclerosis (TRAIN-BW)
Primary Purpose
Multiple Sclerosis, Gait Disorders, Neurologic, Accidental Fall
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Backward Walking Training
Forward Walking Training
Sponsored by
About this trial
This is an interventional prevention trial for Multiple Sclerosis focused on measuring Backward Walking, Neurorehabilitation
Eligibility Criteria
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
Sites / Locations
- Wayne State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TRAIN-BW
TRAIN-FW
Arm Description
1x/week for 8 weeks + home exercise program
1x/week for 8 weeks + home exercise program
Outcomes
Primary Outcome Measures
Sway during quiet stance
Measured with APDM Sensors
Stepping latency on push-and-release test
Measured with APDM Sensors
Secondary Outcome Measures
Client Satisfaction Questionnaire (CSQ-8)
Scores range from 8-32, with high scores indicating greater satisfaction with the intervention
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.
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.
Number of Falls
Number of falls reported in 6 month period after the intervention ends
Forward and Backward Velocity and Double Support Time
Walking speed and double support time (spatiotemporal measures of gait)
ABC Scale
Balance confidence
Full Information
NCT ID
NCT04091464
First Posted
September 11, 2019
Last Updated
July 25, 2022
Sponsor
Wayne State University
1. Study Identification
Unique Protocol Identification Number
NCT04091464
Brief Title
TRAIN-BW: Backward Walking Training in Multiple Sclerosis
Acronym
TRAIN-BW
Official Title
TRAIN-BW: Backward Walking Training in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Gait Disorders, Neurologic, Accidental Fall
Keywords
Backward Walking, Neurorehabilitation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TRAIN-BW
Arm Type
Experimental
Arm Description
1x/week for 8 weeks + home exercise program
Arm Title
TRAIN-FW
Arm Type
Active Comparator
Arm Description
1x/week for 8 weeks + home exercise program
Intervention Type
Behavioral
Intervention Name(s)
Backward Walking Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Forward Walking Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sway during quiet stance
Description
Measured with APDM Sensors
Time Frame
Change in sway at 8 weeks
Title
Stepping latency on push-and-release test
Description
Measured with APDM Sensors
Time Frame
Change in stepping latency at 8 weeks
Secondary Outcome Measure Information:
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
Scores range from 8-32, with high scores indicating greater satisfaction with the intervention
Time Frame
8 weeks
Title
Patient Global Impression of Change
Description
Perceived Treatment Effect; scores range from 1-7 with higher scores indicating greater perception of improvement related to the intervention.
Time Frame
8 weeks
Title
Number of Active Minutes
Description
Measured with Accelerometry, passively collected for a 1 week period prior to the intervention and again after the intervention concludes 8 weeks later.
Time Frame
Change in Physical Activity measures at 8 weeks
Title
Number of Falls
Description
Number of falls reported in 6 month period after the intervention ends
Time Frame
6 months
Title
Forward and Backward Velocity and Double Support Time
Description
Walking speed and double support time (spatiotemporal measures of gait)
Time Frame
Change in velocity and double support time at 8 weeks
Title
ABC Scale
Description
Balance confidence
Time Frame
Change in balance confidence at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nora Fritz, PhD
Phone
313-577-3495
Email
nnlwsu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nora Fritz, PhD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nora Fritz, PhD, PT, DPT, NCS
Phone
(313) 577-3495
Email
nnlwsu@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TRAIN-BW: Backward Walking Training in Multiple Sclerosis
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