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

NCT04145934 | Completed

• 1 other identifier: 20191
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

fall prevention; walking aid; physical therapy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Self-Reported Falls at 8 months

  Paper Fall Calendars

  daily for 8 months

Secondary Outcomes (1)

• Change from Baseline in Functional Gait Assessment / Dynamic Gait Index

  At baseline, 8 weeks, and 8 months

Other Outcomes (4)

• Change from Baseline in Walking Aid Satisfaction

  At baseline, 8 weeks, and 8 months

• Change from Baseline in Physical Activity

  At baseline, 8 weeks, and 8 months

• Change from Baseline in Walking Ability

  At baseline, 8 weeks, and 8 months

Study Arms (2)

training

EXPERIMENTAL

The subjects receive the ADSTEP intervention

Behavioral: ADSTEP

waitlist

NO INTERVENTION

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.

Interventions

ADSTEP BEHAVIORAL

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.

training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A definite diagnosis of MS of any type;
• years of age or older;
• Self-reported history of at least one fall in the previous year;
• Ability to walk at least 25 feet with or without an assistive device;
• Intermittent or constant unilateral or bilateral assistance required to walk;
• No MS exacerbations for the past 30 days;
• Willingness to complete a written daily record of falls for about 8 months.

You may not qualify if:

• Currently receiving physical therapy, or having any plans to receive physical therapy in the upcoming 8 months (duration of study participation);
• Serious psychiatric or medical conditions that would preclude reliable participation in the study (e.g. dementia, deafness, blindness);
• Inability to follow directions in English.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Portland VA Medical Center: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Michelle Cameron, PT, MD, MCR

  Oregon Health & Science University / VA Portland Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: February 6, 2020
• Primary Completion: January 26, 2023
• Study Completion: January 26, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available shortly after completion of data collection (anticipated for December 2021). Data will be available indefinitely thereafter.
• Access Criteria: Execution of a data use agreement with VA Portland Health Care System

Locations

US (1)