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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: ADSTEP

• Registration Number: NCT04145934
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-31
• Study Start: 2020-02-06
• Primary Completion: 2023-01-26
• Study Completion: 2023-01-26
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
training	ADSTEP	The subjects receive the ADSTEP intervention

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Self-Reported Falls at 8 months	daily for 8 months	Paper Fall Calendars

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Functional Gait Assessment / Dynamic Gait Index	At baseline, 8 weeks, and 8 months	Functional Gait Assessment / Dynamic Gait Index

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States