Multiple Sclerosis
Conditions
Keywords
fall prevention, walking aid, physical therapy
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.
Interventions
BEHAVIORALADSTEP
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.
Sponsors
Portland VA Medical Center
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. A definite diagnosis of MS of any type; 2. 18 years of age or older; 3. Self-reported history of at least one fall in the previous year; 4. Ability to walk at least 25 feet with or without an assistive device; 5. Intermittent or constant unilateral or bilateral assistance required to walk; 6. No MS exacerbations for the past 30 days; 7. Willingness to complete a written daily record of falls for about 8 months.
Exclusion criteria
1. Currently receiving physical therapy, or having any plans to receive physical therapy in the upcoming 8 months (duration of study participation); 2. Serious psychiatric or medical conditions that would preclude reliable participation in the study (e.g. dementia, deafness, blindness); 3. Inability to follow directions in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Self-Reported Falls at 8 months | daily for 8 months | Paper Fall Calendars |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Functional Gait Assessment / Dynamic Gait Index | At baseline, 8 weeks, and 8 months | Functional Gait Assessment / Dynamic Gait Index |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Walking Aid Satisfaction | At baseline, 8 weeks, and 8 months | Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) |
| Change from Baseline in Physical Activity | At baseline, 8 weeks, and 8 months | International Physical Activity Questionnaire (IPAQ) |
| Change from Baseline in Walking Ability | At baseline, 8 weeks, and 8 months | Multiple Sclerosis Walking Scale-12 (MSWS-12). Min/max score: 12/60, higher indicates worse outcome |
| Change from Baseline in Quality of Life | At baseline, 8 weeks, and 8 months | Multiple Sclerosis Impact Scale-29 (MSIS-29). Min/max score: 29/145, higher indicates worse outcome |
Countries
United States
Outcome results
None listed