Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2012-03-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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High Therapy Dose
Sixty total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist).
Accelerated Skill Acquisition Program (ASAP)
A focused, intense, evidence-based, upper extremity rehabilitation program. The training intervention is based on the fundamental elements of skill acquisition through task-specific practice, impairment mitigation to increase capacity, and motivational enhancements to build self-confidence Dosage of therapy (number of hours of therapy) will vary based on group assignment. Frequency is 4x/week, 1 week per month for 3 months in a train-wait-train paradigm. A 2-hour orientation session precedes the first visit.
Moderate Therapy Dose
Thirty total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist).
Accelerated Skill Acquisition Program (ASAP)
A focused, intense, evidence-based, upper extremity rehabilitation program. The training intervention is based on the fundamental elements of skill acquisition through task-specific practice, impairment mitigation to increase capacity, and motivational enhancements to build self-confidence Dosage of therapy (number of hours of therapy) will vary based on group assignment. Frequency is 4x/week, 1 week per month for 3 months in a train-wait-train paradigm. A 2-hour orientation session precedes the first visit.
Low Therapy Dose
Fifteen total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist).
Accelerated Skill Acquisition Program (ASAP)
A focused, intense, evidence-based, upper extremity rehabilitation program. The training intervention is based on the fundamental elements of skill acquisition through task-specific practice, impairment mitigation to increase capacity, and motivational enhancements to build self-confidence Dosage of therapy (number of hours of therapy) will vary based on group assignment. Frequency is 4x/week, 1 week per month for 3 months in a train-wait-train paradigm. A 2-hour orientation session precedes the first visit.
Active Monitoring
This is an observation only group.
Active Monitoring
This is an observation-only group. Any therapy received while in this group will be dosed according to usual and customary practice.
Interventions
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Accelerated Skill Acquisition Program (ASAP)
A focused, intense, evidence-based, upper extremity rehabilitation program. The training intervention is based on the fundamental elements of skill acquisition through task-specific practice, impairment mitigation to increase capacity, and motivational enhancements to build self-confidence Dosage of therapy (number of hours of therapy) will vary based on group assignment. Frequency is 4x/week, 1 week per month for 3 months in a train-wait-train paradigm. A 2-hour orientation session precedes the first visit.
Active Monitoring
This is an observation-only group. Any therapy received while in this group will be dosed according to usual and customary practice.
Eligibility Criteria
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Inclusion Criteria
* At least 21 years of age
* Persistent arm and hand weakness, with some ability to release a grasp
* Able to provide consent to participate
* No history of a medical condition that limited arm or hand use prior to the stroke
* Medically stable
* Able to participate for 10 months and attend evaluations at the University of Southern California (USC) Health Sciences Campus.
* Able to communicate in English or Spanish.
Exclusion Criteria
* Neglect
* Current major depressive disorder
* Severe arthritis or orthopedic problems that limit arm or hand movement
* Pain that interferes with daily activities
* Currently enrolled in other rehabilitation or drug intervention studies
* Living too far from the training site to participate reliably
* Receiving oral or injected anti-spasticity medications during study treatment.
* Pregnancy.
21 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Southern California
OTHER
Responsible Party
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Carolee Winstein
Professor
Principal Investigators
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Carolee Winstein, PhD, PT, FAPTA
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Nicolas Schweighofer, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Clarisa Martinez, PT, DPT
Role: STUDY_DIRECTOR
University of Southern California
Locations
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University of Southern California-Health Sciences Campus
Los Angeles, California, United States
Countries
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References
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Schweighofer N, Ye D, Luo H, D'Argenio DZ, Winstein C. Long-term forecasting of a motor outcome following rehabilitation in chronic stroke via a hierarchical bayesian dynamic model. J Neuroeng Rehabil. 2023 Jun 29;20(1):83. doi: 10.1186/s12984-023-01202-y.
Winstein C, Kim B, Kim S, Martinez C, Schweighofer N. Dosage Matters. Stroke. 2019 Jul;50(7):1831-1837. doi: 10.1161/STROKEAHA.118.023603. Epub 2019 Jun 5.
Other Identifiers
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