A Randomized Controlled Trial of a Multicomponent Walking Aid Program for People With MS

Oregon Health and Science University78 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Multiple Sclerosis

ADSTEPBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change from Baseline in Self-Reported Falls at 8 months

Paper Fall Calendars

Time frame: daily for 8 months

Secondary Outcomes

Change from Baseline in Functional Gait Assessment / Dynamic Gait Index

Functional Gait Assessment / Dynamic Gait Index

Time frame: At baseline, 8 weeks, and 8 months