A Randomized Controlled Trial of a Multicomponent Walking Aid Program for People With MS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Self-Reported Falls at 8 months
Study Overview
Brief Summary
This is a randomized controlled trial of the Assistive Device Selection, Training, and Education Program (ADSTEP). ADSTEP is a training program of six weekly one-on-one sessions with a physical therapist intended to reduce falls among people who use a hand-held walking aid, such as a cane or a walker. ADSTEP focuses on training in the use of the walking aid, and includes gait evaluation, walking aid selection and fitting, and progressive task-oriented training with the walking aid.
Participants will be randomized to receive ADSTEP or a waitlist control intervention; those in the control condition will receive National MS Society brochures on fall prevention and walking aid selection, and a letter will be sent informing their care provider that the subject reports falling. All subjects will complete an assessment visit at baseline, and follow-up assessments at about 8 weeks and about 6 months after that. Subjects will complete paper questionnaires of patient reported outcomes (PROs), a modified Functional Gait Assessment / Dynamic Gait Index, and will track fall sustained over their participation in the study using monthly paper fall calendars. At the end of study participation, all subjects in the control group will be offered the opportunity to receive ADSTEP.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A definite diagnosis of MS of any type;
- •18 years of age or older;
- •Self-reported history of at least one fall in the previous year;
- •Ability to walk at least 25 feet with or without an assistive device;
- •Intermittent or constant unilateral or bilateral assistance required to walk;
- •No MS exacerbations for the past 30 days;
- •Willingness to complete a written daily record of falls for about 8 months.
Exclusion Criteria
- •Currently receiving physical therapy, or having any plans to receive physical therapy in the upcoming 8 months (duration of study participation);
- •Serious psychiatric or medical conditions that would preclude reliable participation in the study (e.g. dementia, deafness, blindness);
- •Inability to follow directions in English.
Arms & Interventions
training
The subjects receive the ADSTEP intervention
Intervention: ADSTEP (Behavioral)
waitlist
These subjects receive two brochures on fall prevention and walking aid selection, and a letter is sent to their care provider informing them that the subject has reported falling. Subjects in this group will be offered the ADSTEP intervention once their study participation is complete.
Outcomes
Primary Outcomes
Change from Baseline in Self-Reported Falls at 8 months
Time Frame: daily for 8 months
Paper Fall Calendars
Secondary Outcomes
- Change from Baseline in Functional Gait Assessment / Dynamic Gait Index(At baseline, 8 weeks, and 8 months)
Investigators
Michelle Cameron
Neurologist
Oregon Health and Science University