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Assistive Device Training in Multiple Sclerosis (ADT)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assistive Device Training
Sponsored by
Portland VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Mobility, walking aids, falls, gait and balance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Multiple Sclerosis of any type,
  • self-reported history of at least 1 fall in the previous year,
  • able to walk at least 25 feet with or without an assistive device,
  • clinically stable Multiple Sclerosis (no relapse in 30 days prior to enrollment),
  • intermittent or constant unilateral or bilateral assistance required to walk,
  • right-handed, willingness to remain consistent with medication use and level of physical activity for the duration of the study.

Exclusion Criteria:

  • serious psychiatric or medical conditions that would preclude reliable participation in the study,
  • dementia (MMSE <24),
  • deafness,
  • blindness,
  • inability to follow directions in English,
  • significant upper extremity tremor or weakness,
  • more than 1 hour of assistive device training within the previous 3 years,
  • any exclusions to receiving MRI scans (implanted devices, anxiety, claustrophobia, body weight over 350 lbs).

Sites / Locations

  • VA Portland Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Training group

Wait-list control

Arm Description

Subjects randomized to this group will receive a 6 week Assistive Device Training program in the use of their assistive device. They will have mobility assessments taken at baseline, after the training program has been completed, and 3 months later. During this time, their falls will be recorded monthly using prospective falls calendars. Members of this group will also receive MRI scans at baseline and after the completion of the training program.

Subjects in this group will participate in the same mobility assessments and completion of the falls calendars, but will receive no intervention during this time. These subjects will have the opportunity to receive the training sessions when all assessment visits have been completed. These subjects will not receive MRI scans.

Outcomes

Primary Outcome Measures

Change from Baseline in Functional Mobility at Completion of Training and the Following Three Months
Timed Up and Go test, Timed 25-Foot Walk, 2 minute timed walk), Multiple Sclerosis Walking Scale-12
Change from Baseline in Falls at Completion of Training and the Following Three Months
Change in rate of falls between time frames
Change from Baseline in Functional Neural Connectivity (fMRI) at Completion of Training
Resting-state (task free) functional Magnetic Resonance Imaging (fcMRI)

Secondary Outcome Measures

Change from Baseline in Satisfaction with Assistive Device at Completion of Training and the Following Three Months
Quebec User Evaluation of Satisfaction with Assistive Technologies
Change from Baseline in Balance Confidence at Completion of Training and the Following Three Months
Activities-specific Balance Confidence Questionnaire
Change from Baseline in Multiple Sclerosis Impact at Completion of Training and the Following Three Months
Multiple Sclerosis Impact Scale-29
Change from Baseline in Physical Activity at Completion of Training and the Following Three Months
International Physical Activity Questionnaire

Full Information

First Posted
March 27, 2015
Last Updated
September 20, 2016
Sponsor
Portland VA Medical Center
Collaborators
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT02408718
Brief Title
Assistive Device Training in Multiple Sclerosis
Acronym
ADT
Official Title
Assistive Device Training for Functional Mobility and Connectivity in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Portland VA Medical Center
Collaborators
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether a training program in the use of ambulatory assistive devices (such as canes, walkers, etc) can reduce falls and increase functional mobility and neural connectivity in people with Multiple Sclerosis.
Detailed Description
40 people with Multiple Sclerosis, who routinely use ambulatory assistive devices and have fallen at least once in the past year, will be randomized into two groups. One group will receive a 6-week training program in the use of their assistive device; the other group will be wait-listed, and may choose to receive the training after their participation in the study is completed. All participants will receive mobility assessments at baseline, 6-8 weeks later, and 3 months after that. All participants will record their falls on falls calendars. Participants in the training group will receive MRI scans to assess neural connectivity at baseline and after completion of the training program. The purpose of the study is to determine whether participation in the training program reduces falls and increases functional mobility when compared to the wait-listed group, and also to determine whether any change in neural connectivity, as assessed by MRI scans, is seen in those who participate in the training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Mobility, walking aids, falls, gait and balance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training group
Arm Type
Active Comparator
Arm Description
Subjects randomized to this group will receive a 6 week Assistive Device Training program in the use of their assistive device. They will have mobility assessments taken at baseline, after the training program has been completed, and 3 months later. During this time, their falls will be recorded monthly using prospective falls calendars. Members of this group will also receive MRI scans at baseline and after the completion of the training program.
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
Subjects in this group will participate in the same mobility assessments and completion of the falls calendars, but will receive no intervention during this time. These subjects will have the opportunity to receive the training sessions when all assessment visits have been completed. These subjects will not receive MRI scans.
Intervention Type
Behavioral
Intervention Name(s)
Assistive Device Training
Intervention Description
Six-week training program on the proper use of the subject's assistive device (eg. cane, walker, etc).
Primary Outcome Measure Information:
Title
Change from Baseline in Functional Mobility at Completion of Training and the Following Three Months
Description
Timed Up and Go test, Timed 25-Foot Walk, 2 minute timed walk), Multiple Sclerosis Walking Scale-12
Time Frame
At baseline, 1 week after completion of training, 3 months later
Title
Change from Baseline in Falls at Completion of Training and the Following Three Months
Description
Change in rate of falls between time frames
Time Frame
First week of training, last week of training, 3 months later
Title
Change from Baseline in Functional Neural Connectivity (fMRI) at Completion of Training
Description
Resting-state (task free) functional Magnetic Resonance Imaging (fcMRI)
Time Frame
At baseline, 1 week after completion of training
Secondary Outcome Measure Information:
Title
Change from Baseline in Satisfaction with Assistive Device at Completion of Training and the Following Three Months
Description
Quebec User Evaluation of Satisfaction with Assistive Technologies
Time Frame
At baseline, 1 week after completion of training, 3 months later
Title
Change from Baseline in Balance Confidence at Completion of Training and the Following Three Months
Description
Activities-specific Balance Confidence Questionnaire
Time Frame
At baseline, 1 week after completion of training, 3 months later
Title
Change from Baseline in Multiple Sclerosis Impact at Completion of Training and the Following Three Months
Description
Multiple Sclerosis Impact Scale-29
Time Frame
At baseline, 1 week after completion of training, 3 months later
Title
Change from Baseline in Physical Activity at Completion of Training and the Following Three Months
Description
International Physical Activity Questionnaire
Time Frame
At baseline, 1 week after completion of training, 3 months later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Multiple Sclerosis of any type, self-reported history of at least 1 fall in the previous year, able to walk at least 25 feet with or without an assistive device, clinically stable Multiple Sclerosis (no relapse in 30 days prior to enrollment), intermittent or constant unilateral or bilateral assistance required to walk, right-handed, willingness to remain consistent with medication use and level of physical activity for the duration of the study. Exclusion Criteria: serious psychiatric or medical conditions that would preclude reliable participation in the study, dementia (MMSE <24), deafness, blindness, inability to follow directions in English, significant upper extremity tremor or weakness, more than 1 hour of assistive device training within the previous 3 years, any exclusions to receiving MRI scans (implanted devices, anxiety, claustrophobia, body weight over 350 lbs).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle H. Cameron, MD, PT MCR
Organizational Affiliation
Portland VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29958906
Citation
Martini DN, Zeeboer E, Hildebrand A, Fling BW, Hugos CL, Cameron MH. ADSTEP: Preliminary Investigation of a Multicomponent Walking Aid Program in People With Multiple Sclerosis. Arch Phys Med Rehabil. 2018 Oct;99(10):2050-2058. doi: 10.1016/j.apmr.2018.05.023. Epub 2018 Jun 26.
Results Reference
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Assistive Device Training in Multiple Sclerosis

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