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

Multiple Sclerosis Clinical Trial

— ADSTEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04145934
• Other study ID #: 20191
• Status: Completed
• Phase: N/A
• Start date: February 6, 2020
• Est. completion date: January 26, 2023

Study information

• Verified date: March 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 26, 2023
• Est. primary completion date: January 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis

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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Portland VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change from Baseline in Physical Activity	International Physical Activity Questionnaire (IPAQ)	At baseline, 8 weeks, and 8 months
Other	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
Other	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
Primary	Change from Baseline in Self-Reported Falls at 8 months	Paper Fall Calendars	daily for 8 months
Secondary	Change from Baseline in Functional Gait Assessment / Dynamic Gait Index	Functional Gait Assessment / Dynamic Gait Index	At baseline, 8 weeks, and 8 months