Assistive Device Training in Multiple Sclerosis (ADT)

Assistive Device Training for Functional Mobility and Connectivity in Multiple Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Assistive Device Training

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • VA Portland Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Training group; 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.	Behavioral: Assistive Device Training; Six-week training program on the proper use of the subject's assistive device (eg. cane, walker, etc).
No Intervention: Wait-list control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At baseline, 1 week after completion of training, 3 months later
Change from Baseline in Falls at Completion of Training and the Following Three Months	Change in rate of falls between time frames	First week of training, last week of training, 3 months later
Change from Baseline in Functional Neural Connectivity (fMRI) at Completion of Training	Resting-state (task free) functional Magnetic Resonance Imaging (fcMRI)	At baseline, 1 week after completion of training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At baseline, 1 week after completion of training, 3 months later
Change from Baseline in Balance Confidence at Completion of Training and the Following Three Months	Activities-specific Balance Confidence Questionnaire	At baseline, 1 week after completion of training, 3 months later
Change from Baseline in Multiple Sclerosis Impact at Completion of Training and the Following Three Months	Multiple Sclerosis Impact Scale-29	At baseline, 1 week after completion of training, 3 months later
Change from Baseline in Physical Activity at Completion of Training and the Following Three Months	International Physical Activity Questionnaire	At baseline, 1 week after completion of training, 3 months later

Collaborators and Investigators

• Sponsor: Portland VA Medical Center
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Michelle H. Cameron, MD, PT MCR, Portland VA Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: March 27, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Estimate): September 21, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: falls; Mobility; gait and balance; walking aids
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 3559