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

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 Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: ADSTEP

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: training; The subjects receive the ADSTEP intervention	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Self-Reported Falls at 8 months	Paper Fall Calendars	daily for 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Functional Gait Assessment / Dynamic Gait Index	Functional Gait Assessment / Dynamic Gait Index	At baseline, 8 weeks, and 8 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Walking Aid Satisfaction	Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0)	At baseline, 8 weeks, and 8 months
Change from Baseline in Physical Activity	International Physical Activity Questionnaire (IPAQ)	At baseline, 8 weeks, and 8 months
Change from Baseline in Walking Ability	Multiple Sclerosis Walking Scale-12 (MSWS-12). Min/max score: 12/60, higher indicates worse outcome	At baseline, 8 weeks, and 8 months
Change from Baseline in Quality of Life	Multiple Sclerosis Impact Scale-29 (MSIS-29). Min/max score: 29/145, higher indicates worse outcome	At baseline, 8 weeks, and 8 months

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Portland VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2020
• Primary Completion (Actual): January 26, 2023
• Study Completion (Actual): January 26, 2023

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: physical therapy; fall prevention; walking aid
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: 20191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data obtained will be placed in a data repository maintained at the VA Portland Health Care System. Data in the repository will be accessible to other researchers at the discretion of the repository director, upon execution of a data use agreement.
• IPD Sharing Time Frame: Data will become available shortly after completion of data collection (anticipated for December 2021). Data will be available indefinitely thereafter.
• IPD Sharing Access Criteria: Execution of a data use agreement with VA Portland Health Care System

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No