Assistive Device Training in Multiple Sclerosis (ADT)

Portland VA Medical Center

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Assistive Device Training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02408718

3559

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Training group

Active Comparator group

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.

Treatment:

Behavioral: Assistive Device Training

Wait-list control

No Intervention group

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.