- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02408718
Assistive Device Training in Multiple Sclerosis (ADT)
Assistive Device Training for Functional Mobility and Connectivity in Multiple Sclerosis
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Oregon
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Portland, Oregon, Förenta staterna, 97239
- VA Portland Health Care System
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Training group
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.
|
Six-week training program on the proper use of the subject's assistive device (eg.
cane, walker, etc).
|
Inget ingripande: Wait-list control
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change from Baseline in Functional Mobility at Completion of Training and the Following Three Months
Tidsram: 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
|
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
Tidsram: First week of training, last week of training, 3 months later
|
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
Tidsram: At baseline, 1 week after completion of training
|
Resting-state (task free) functional Magnetic Resonance Imaging (fcMRI)
|
At baseline, 1 week after completion of training
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change from Baseline in Satisfaction with Assistive Device at Completion of Training and the Following Three Months
Tidsram: At baseline, 1 week after completion of training, 3 months later
|
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
Tidsram: At baseline, 1 week after completion of training, 3 months later
|
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
Tidsram: At baseline, 1 week after completion of training, 3 months later
|
Multiple Sclerosis Impact Scale-29
|
At baseline, 1 week after completion of training, 3 months later
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Change from Baseline in Physical Activity at Completion of Training and the Following Three Months
Tidsram: At baseline, 1 week after completion of training, 3 months later
|
International Physical Activity Questionnaire
|
At baseline, 1 week after completion of training, 3 months later
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Michelle H. Cameron, MD, PT MCR, Portland VA Medical Center
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 3559
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