Multiple SclerosisADTNCT02408718
Assistive Device Training in Multiple Sclerosis
A study testing Assistive Device Training in people with Multiple Sclerosis, run by Portland VA Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a training program in the use of ambulatory assistive devices (such as canes, walkers, etc) can reduce falls and increase functional mobility and neural connectivity in people with Multiple Sclerosis. 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?
- Assistive Device Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Sep 2016
- 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
- Multiple Sclerosis of any type,
- self-reported history of at least 1 fall in the previous year,
- able to walk at least 25 feet with or without an assistive device,
- clinically stable Multiple Sclerosis (no relapse in 30 days prior to enrollment),
- intermittent or constant unilateral or bilateral assistance required to walk,
- right-handed, willingness to remain consistent with medication use and level of physical activity for the duration of the study.
Who cannot join
- serious psychiatric or medical conditions that would preclude reliable participation in the study,
- dementia (MMSE <24),
- deafness,
- blindness,
- inability to follow directions in English,
- significant upper extremity tremor or weakness,
- more than 1 hour of assistive device training within the previous 3 years,
- any exclusions to receiving MRI scans (implanted devices, anxiety, claustrophobia, body weight over 350 lbs).
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System
Portland, Oregon, 97239
About this study
Official title: Assistive Device Training for Functional Mobility and Connectivity in Multiple Sclerosis
The purpose of this study is to determine whether a training program in the use of ambulatory assistive devices (such as canes, walkers, etc) can reduce falls and increase functional mobility and neural connectivity in people with Multiple Sclerosis.
Read the detailed description
40 people with Multiple Sclerosis, who routinely use ambulatory assistive devices and have fallen at least once in the past year, will be randomized into two groups. One group will receive a 6-week training program in the use of their assistive device; the other group will be wait-listed, and may choose to receive the training after their participation in the study is completed. All participants will receive mobility assessments at baseline, 6-8 weeks later, and 3 months after that. All participants will record their falls on falls calendars. Participants in the training group will receive MRI scans to assess neural connectivity at baseline and after completion of the training program.
The purpose of the study is to determine whether participation in the training program reduces falls and increases functional mobility when compared to the wait-listed group, and also to determine whether any change in neural connectivity, as assessed by MRI scans, is seen in those who participate in the training.
- Conditions
- Multiple Sclerosis
- Being tested
- Assistive Device Training
- Keywords
- Mobility, walking aids, falls, gait and balance
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assistive Device TrainingBehavioural
Six-week training program on the proper use of the subject's assistive device (eg. cane, walker, etc).
| Study group | Role | What they receive |
|---|---|---|
| Training group | Active comparator | Subjects randomized to this group will receive a 6 week Assistive Device Training program in the use of their assistive device. They will have mobility assessments taken at baseline, after the training program has been completed, and 3 months later. During this time, their falls will be recorded monthly using prospective falls calendars. Members of this group will also receive MRI scans at baseline and after the completion of the training program. Receives: Behavioral: Assistive Device Training |
| Wait-list control | No intervention | Subjects in this group will participate in the same mobility assessments and completion of the falls calendars, but will receive no intervention during this time. These subjects will have the opportunity to receive the training sessions when all assessment visits have been completed. These subjects will not receive MRI scans. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Functional Mobility at Completion of Training and the Following Three Months
Timed Up and Go test, Timed 25-Foot Walk, 2 minute timed walk), Multiple Sclerosis Walking Scale-12
Measured: At baseline, 1 week after completion of training, 3 months later
Change from Baseline in Falls at Completion of Training and the Following Three Months
Change in rate of falls between time frames
Measured: First week of training, last week of training, 3 months later
Change from Baseline in Functional Neural Connectivity (fMRI) at Completion of Training
Resting-state (task free) functional Magnetic Resonance Imaging (fcMRI)
Measured: At baseline, 1 week after completion of training
Secondary outcomes (4)
Change from Baseline in Satisfaction with Assistive Device at Completion of Training and the Following Three Months
Quebec User Evaluation of Satisfaction with Assistive Technologies
Measured: At baseline, 1 week after completion of training, 3 months later
Change from Baseline in Balance Confidence at Completion of Training and the Following Three Months
Activities-specific Balance Confidence Questionnaire
Measured: At baseline, 1 week after completion of training, 3 months later
Change from Baseline in Multiple Sclerosis Impact at Completion of Training and the Following Three Months
Multiple Sclerosis Impact Scale-29
Measured: At baseline, 1 week after completion of training, 3 months later
Change from Baseline in Physical Activity at Completion of Training and the Following Three Months
International Physical Activity Questionnaire
Measured: At baseline, 1 week after completion of training, 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portland VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Michelle H. Cameron, MD, PT, MCR, Portland VA Medical Center
- Investigators
- Michelle H. Cameron, MD, PT MCR, Principal investigator, Portland VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408718
- Sponsor's protocol ID
- 3559
- Acronym
- ADT
- Status last verified
- Apr 2016
- First submitted
- 27 Mar 2015
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Martini DN, Zeeboer E, Hildebrand A, Fling BW, Hugos CL, Cameron MH. ADSTEP: Preliminary Investigation of a Multicomponent Walking Aid Program in People With Multiple Sclerosis. Arch Phys Med Rehabil. 2018 Oct;99(10):2050-2058. doi: 10.1016/j.apmr.2018.05.023. Epub 2018 Jun 26.
PubMed 29958906
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistive Device Training for Functional Mobility and Connectivity in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02408718
- Acronym / sponsor ID
- ADT / 3559
- Conditions
- Multiple Sclerosis
- Keywords
- Mobility, walking aids, falls, gait and balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Portland VA Medical CenterUS federal agency
- Collaborators
- Oregon Health and Science University
- Study start
- Jul 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 3 Apr 2015 (estimated)
- 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.
The purpose of this study is to determine whether a training program in the use of ambulatory assistive devices (such as canes, walkers, etc) can reduce falls and increase functional mobility and neural connectivity in people with Multiple Sclerosis.
Detailed description
40 people with Multiple Sclerosis, who routinely use ambulatory assistive devices and have fallen at least once in the past year, will be randomized into two groups. One group will receive a 6-week training program in the use of their assistive device; the other group will be wait-listed, and may choose to receive the training after their participation in the study is completed. All participants will receive mobility assessments at baseline, 6-8 weeks later, and 3 months after that. All participants will record their falls on falls calendars. Participants in the training group will receive MRI scans to assess neural connectivity at baseline and after completion of the training program.
The purpose of the study is to determine whether participation in the training program reduces falls and increases functional mobility when compared to the wait-listed group, and also to determine whether any change in neural connectivity, as assessed by MRI scans, is seen in those who participate in the training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Active comparator | Behavioral: Assistive Device TrainingSubjects randomized to this group will receive a 6 week Assistive Device Training program in the use of their assistive device. They will have mobility assessments taken at baseline, after the training program has been completed, and 3 months later. During this time, their falls will be recorded monthly using prospective falls calendars. Members of this group will also receive MRI scans at baseline and after the completion of the training program. |
| Wait-list control | No intervention | –Subjects in this group will participate in the same mobility assessments and completion of the falls calendars, but will receive no intervention during this time. These subjects will have the opportunity to receive the training sessions when all assessment visits have been completed. These subjects will not receive MRI scans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Multiple Sclerosis of any type,
- self-reported history of at least 1 fall in the previous year,
- able to walk at least 25 feet with or without an assistive device,
- clinically stable Multiple Sclerosis (no relapse in 30 days prior to enrollment),
- intermittent or constant unilateral or bilateral assistance required to walk,
Key exclusion criteria (8 listed)
- serious psychiatric or medical conditions that would preclude reliable participation in the study,
- dementia (MMSE <24),
- 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 |
|---|---|---|
| Assistive Device TrainingSix-week training program on the proper use of the subject's assistive device (eg. cane, walker, etc). | Behavioural | Training group |
Primary outcome
Change from Baseline in Functional Mobility at Completion of Training and the Following Three Months
Time frame: At baseline, 1 week after completion of training, 3 months later
Timed Up and Go test, Timed 25-Foot Walk, 2 minute timed walk), Multiple Sclerosis Walking Scale-12
Change from Baseline in Falls at Completion of Training and the Following Three Months
Time frame: First week of training, last week of training, 3 months later
Change in rate of falls between time frames
Change from Baseline in Functional Neural Connectivity (fMRI) at Completion of Training
Time frame: At baseline, 1 week after completion of training
Resting-state (task free) functional Magnetic Resonance Imaging (fcMRI)
4 secondary outcomes
Change from Baseline in Satisfaction with Assistive Device at Completion of Training and the Following Three Months
Time frame: At baseline, 1 week after completion of training, 3 months later
Change from Baseline in Balance Confidence at Completion of Training and the Following Three Months
Time frame: At baseline, 1 week after completion of training, 3 months later
Change from Baseline in Multiple Sclerosis Impact at Completion of Training and the Following Three Months
Time frame: At baseline, 1 week after completion of training, 3 months later
Change from Baseline in Physical Activity at Completion of Training and the Following Three Months
Time frame: At baseline, 1 week after completion of training, 3 months later
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 21 Sep 2016.
- Derived from this study: PubMed 29958906Martini DN, Zeeboer E, Hildebrand A, Fling BW, Hugos CL, Cameron MH. ADSTEP: Preliminary Investigation of a Multicomponent Walking Aid Program in People With Multiple Sclerosis. Arch Phys Med Rehabil. 2018 Oct;99(10):2050-2058. doi: 10.1016/j.apmr.2018.05.023. Epub 2018 Jun 26.
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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 H. Cameron, MD, PT MCR principal investigator
Portland VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assistive Device Training in people with Multiple Sclerosis, run by Portland VA Medical Center 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 6 inclusion and 8 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 21 Sep 2016. 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 Functional Mobility at Completion of Training and the Following Three Months (time frame: At baseline, 1 week after completion of training, 3 months later). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02408718, which also lists 1 linked publication.
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 21 Sep 2016.