Assistive Device Training in Multiple Sclerosis

Portland VA Medical Center40 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Assistive Device TrainingBEHAVIORAL

Six-week training program on the proper use of the subject's assistive device (eg. cane, walker, etc).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

VA Portland Health Care System

Portland, Oregon, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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)

Time frame: At baseline, 1 week after completion of training

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: At baseline, 1 week after completion of training, 3 months later

Data from ClinicalTrials.gov

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