Clinical trial NCT02408718: Assistive Device Training in Multiple Sclerosis
Official title: Assistive Device Training for Functional Mobility and Connectivity in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Mobility
walking aids
falls
gait and balance
Lead sponsor: Portland VA Medical Center
Sponsor class: FED
Collaborators: name: Oregon Health and Science University
First posted: 2015-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Change from Baseline in Functional Mobility at Completion of Training and the Following Three Months
timeFrame: At baseline, 1 week after completion of training, 3 months later
measure: Change from Baseline in Falls at Completion of Training and the Following Three Months
timeFrame: First week of training, last week of training, 3 months later
measure: Change from Baseline in Functional Neural Connectivity (fMRI) at Completion of Training
timeFrame: At baseline, 1 week after completion of training
Secondary outcomes:
measure: Change from Baseline in Satisfaction with Assistive Device at Completion of Training and the Following Three Months
timeFrame: At baseline, 1 week after completion of training, 3 months later
measure: Change from Baseline in Balance Confidence at Completion of Training and the Following Three Months
timeFrame: At baseline, 1 week after completion of training, 3 months later
measure: Change from Baseline in Multiple Sclerosis Impact at Completion of Training and the Following Three Months
timeFrame: At baseline, 1 week after completion of training, 3 months later
measure: Change from Baseline in Physical Activity at Completion of Training and the Following Three Months
timeFrame: At baseline, 1 week after completion of training, 3 months later
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
Study officials:
affiliation: Portland VA Medical Center
name: Michelle H. Cameron, MD, PT MCR
role: PRINCIPAL_INVESTIGATOR
References:
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.