Multiple SclerosisADSTEPNCT04145934
A Randomized Controlled Trial of a Multicomponent Walking Aid Program for People With MS
A study testing ADSTEP in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- ADSTEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2020to 26 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
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
- Being tested
- ADSTEP
- Keywords
- fall prevention, walking aid, physical therapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADSTEPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| training | Experimental | The subjects receive the ADSTEP intervention Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Self-Reported Falls at 8 months
Paper Fall Calendars
Measured: daily for 8 months
Secondary outcomes (1)
Change from Baseline in Functional Gait Assessment / Dynamic Gait Index
Functional Gait Assessment / Dynamic Gait Index
Measured: At baseline, 8 weeks, and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start6 Feb 2020
- Primary completion26 Jan 2023
- Study completion26 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Portland VA Medical Center
- Responsible party
- Principal investigator, Michelle Cameron, Oregon Health and Science University
- Investigators
- Michelle Cameron, PT, MD, MCR, Principal investigator, Oregon Health & Science University / VA Portland Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145934
- Sponsor's protocol ID
- 20191
- Acronym
- ADSTEP
- Status last verified
- Mar 2023
- First submitted
- 29 Oct 2019
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Multicomponent Walking Aid Program for People With MS
- ClinicalTrials.gov ID
- NCT04145934
- Acronym / sponsor ID
- ADSTEP / 20191
- Conditions
- Multiple Sclerosis
- Keywords
- fall prevention, walking aid, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Portland VA Medical Center
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training | Experimental | Behavioral: ADSTEPThe subjects receive the ADSTEP intervention |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADSTEPADSTEP 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. | Behavioural | training |
Primary outcome
Change from Baseline in Self-Reported Falls at 8 months
Time frame: daily for 8 months
Paper Fall Calendars
1 secondary outcome
Change from Baseline in Functional Gait Assessment / Dynamic Gait Index
Time frame: At baseline, 8 weeks, and 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Cameron, PT, MD, MCR principal investigator
Oregon Health & Science University / VA Portland Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADSTEP in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Self-Reported Falls at 8 months (time frame: daily for 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.