A Randomized Controlled Trial of a Multicomponent Walking Aid Program for People With MS (ADSTEP)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADSTEP
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Sclerosis focused on measuring fall prevention, walking aid, physical therapy
Eligibility Criteria
Inclusion Criteria:
- A definite diagnosis of MS of any type;
- 18 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
training
waitlist
Arm Description
The subjects receive the ADSTEP 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.
Outcomes
Primary Outcome Measures
Change from Baseline in Self-Reported Falls at 8 months
Paper Fall Calendars
Secondary Outcome Measures
Change from Baseline in Functional Gait Assessment / Dynamic Gait Index
Functional Gait Assessment / Dynamic Gait Index
Full Information
NCT ID
NCT04145934
First Posted
October 29, 2019
Last Updated
March 21, 2023
Sponsor
Oregon Health and Science University
Collaborators
Portland VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04145934
Brief Title
A Randomized Controlled Trial of a Multicomponent Walking Aid Program for People With MS
Acronym
ADSTEP
Official Title
A Randomized Controlled Trial of a Multicomponent Walking Aid Program for People With MS
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 6, 2020 (Actual)
Primary Completion Date
January 26, 2023 (Actual)
Study Completion Date
January 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Portland VA Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
fall prevention, walking aid, physical therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
training
Arm Type
Experimental
Arm Description
The subjects receive the ADSTEP intervention
Arm Title
waitlist
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ADSTEP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Self-Reported Falls at 8 months
Description
Paper Fall Calendars
Time Frame
daily for 8 months
Secondary Outcome Measure Information:
Title
Change from Baseline in Functional Gait Assessment / Dynamic Gait Index
Description
Functional Gait Assessment / Dynamic Gait Index
Time Frame
At baseline, 8 weeks, and 8 months
Other Pre-specified Outcome Measures:
Title
Change from Baseline in Walking Aid Satisfaction
Description
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0)
Time Frame
At baseline, 8 weeks, and 8 months
Title
Change from Baseline in Physical Activity
Description
International Physical Activity Questionnaire (IPAQ)
Time Frame
At baseline, 8 weeks, and 8 months
Title
Change from Baseline in Walking Ability
Description
Multiple Sclerosis Walking Scale-12 (MSWS-12). Min/max score: 12/60, higher indicates worse outcome
Time Frame
At baseline, 8 weeks, and 8 months
Title
Change from Baseline in Quality of Life
Description
Multiple Sclerosis Impact Scale-29 (MSIS-29). Min/max score: 29/145, higher indicates worse outcome
Time Frame
At baseline, 8 weeks, and 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A definite diagnosis of MS of any type;
18 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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Cameron, PT, MD, MCR
Organizational Affiliation
Oregon Health & Science University / VA Portland Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
A Randomized Controlled Trial of a Multicomponent Walking Aid Program for People With MS
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