Clinical trial NCT04145934: A Randomized Controlled Trial of a Multicomponent Walking Aid Program for People With MS
Official title: A Randomized Controlled Trial of a Multicomponent Walking Aid Program for People With MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: fall prevention
walking aid
physical therapy
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Portland VA Medical Center
First posted: 2019-10-31
Enrollment: 78
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: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Self-Reported Falls at 8 months
timeFrame: daily for 8 months
Secondary outcomes:
measure: Change from Baseline in Functional Gait Assessment / Dynamic Gait Index
timeFrame: At baseline, 8 weeks, and 8 months
Other outcomes:
measure: Change from Baseline in Walking Aid Satisfaction
timeFrame: At baseline, 8 weeks, and 8 months
measure: Change from Baseline in Physical Activity
timeFrame: At baseline, 8 weeks, and 8 months
measure: Change from Baseline in Walking Ability
timeFrame: At baseline, 8 weeks, and 8 months
measure: Change from Baseline in Quality of Life
timeFrame: At baseline, 8 weeks, and 8 months
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health & Science University / VA Portland Health Care System
name: Michelle Cameron, PT, MD, MCR
role: PRINCIPAL_INVESTIGATOR
References: