Does More Practice Improve Arm Movement After Stroke?
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| First Received Date ICMJE | June 3, 2010 | ||||||||
| Last Updated Date | May 26, 2011 | ||||||||
| Start Date ICMJE | May 2010 | ||||||||
| Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Action Research Arm Test (ARAT) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ] Standardized assessment of upper extremity function |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01146379 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Does More Practice Improve Arm Movement After Stroke? | ||||||||
| Official Title ICMJE | Dose Response of Movement Practice During Stroke Rehabilitation | ||||||||
| Brief Summary | Arm weakness happens a lot after a stroke. People often get physical or occupational therapy after their stroke to learn how to use their arm again. This study will help figure out how much therapy should be given to restore as much arm function as possible. |
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| Detailed Description | Dose has emerged as a key factor promoting functional recovery after stroke. Currently, a lack of data on the dose-response relationship impedes progress in the field of stroke rehabilitation. The goal of the proposed project is to define the range of doses of movement practice that produce the greatest improvements in outcomes in people with chronic stroke. Borrowing from animal models of stroke, dose in humans can be quantified by the number of repetitions of task-specific practice. Our central hypothesis is that there exists a range of doses for people with stroke, below which, there is minimal benefit, and above which, further practice does not result in further benefit. The range of beneficial doses is likely to vary based on the severity of motor deficits and the presence of non-motor deficits in other domains. Using a randomized, parallel dose-response design, we will evaluate the benefits of four different doses of task-specific upper extremity training with matched schedules of 1 hr sessions, 4 sessions/wk for 8 wks, in 100 people with chronic stroke. Total repetition doses to be evaluated (3200, 6400, 9600, & individualized-maximum) are based on our preliminary data. The individualized-maximum group may extend their sessions beyond 8 wks until meeting defined stop criteria. Our primary aim will test whether larger total doses result in better outcomes than smaller total doses. Benefits of the four doses will be evaluated at the impairment, activity, and participation levels, since understanding the dose-response relationship at all levels of measurement is critical for advancing rehabilitation research. We hypothesize that improvements will be greatest in the 9600 and individualized-maximum, followed by the 6400, and then the 3200 repetition dose groups. Our secondary aim is to characterize the dose-response relationship of upper extremity task-specific practice. With data from multiple assessment points, individual curve modeling will be used to estimate dose ranges, below which, there is minimal benefit, and above which, further practice does not result in further benefit. Furthermore, we will determine how various factors modify the dose estimates. We hypothesize that the severity of motor deficits will be the primary modifier of the dose-response relationship, with larger doses needed for those with more mild motor deficits. We further expect that needed doses will be larger for those with depression and hemispatial neglect. Our team is well-positioned to investigate the critical issue of dose because of our expertise in stroke rehabilitation research and measurement, our understanding of the challenges of clinical practice and clinical research, and our ready access to this patient population. Expected outcomes from this project are empirically-driven estimates indicating the amount of movement practice required to drive maximal improvements and how these estimates can be individually modified for people undergoing stroke rehabilitation. Our estimates will immediately impact rehabilitation research and clinical practice. The importance of this project transcends stroke rehabilitation; our primary results will be of high value to many other rehabilitation populations also impeded by the lack of knowledge regarding dose-response relationships. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Stroke | ||||||||
| Intervention ICMJE | Other: Intensive task-specific upper extremity rehabilitation
The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | May 2015 | ||||||||
| Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01146379 | ||||||||
| Other Study ID Numbers ICMJE | 10-0230 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Catherine E. Lang, PT, PhD, Washington University School of Medicine | ||||||||
| Study Sponsor ICMJE | Washington University School of Medicine | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Washington University School of Medicine | ||||||||
| Verification Date | May 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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