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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assistive Device Training | Behavioral | Six-week training program on the proper use of the subject's assistive device (eg. cane, walker, etc). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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) | At baseline, 1 week after completion of training |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle H. Cameron, MD, PT MCR | Portland VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29958906 | Derived | 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. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Activities-specific Balance Confidence Questionnaire |
| 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 | 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 | At baseline, 1 week after completion of training, 3 months later |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |