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Clinical Trials/NCT01749358
NCT01749358
Completed
Phase 1

Optimizing the Dose of Rehabilitation After Stroke.

University of Southern California1 site in 1 country60 target enrollmentMarch 2012

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Southern California
Enrollment
60
Locations
1
Primary Endpoint
Bilateral Arm Reaching Test (BART)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

This study is about rehabilitation of arm function after a stroke. The investigators are testing the dosage of therapy that is needed for meaningful recovery of arm and hand function. Dosage of therapy refers to the amount of time (in this case, the total number of hours) that a person participates in treatment. The investigators hope to learn how much therapy time is needed in order for change to occur in arm and hand function after a person has had a stroke. Eligible candidates must have had a stroke affecting the use of an arm or hand at least 6 months ago.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
August 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carolee Winstein

Professor

University of Southern California

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Bilateral Arm Reaching Test (BART)

Time Frame: Change from Baseline to up to 10 months post-randomization

BART is a laboratory-based timed-reaching task for people with stroke that was developed to evaluate upper extremity use in free-choice and forced-use scenarios. BART will be performed 2 times at Baseline, pre- and post- intervention and 1 time a month for 6 months during follow-up to assess changes in upper extremity use relative to dosage of therapy.

Wolf Motor Function Test (WMFT)

Time Frame: Change from Baseline to up to 10 months post-randomization

Tests arm function based on time to complete 15 tasks performed with each arm. WMFT will be used to assess change in arm function relative to dose of physical therapy.

Motor Activity Log (MAL)

Time Frame: Change from Baseline to up to 10 months post-randomization

Semi-structured interview in which participants are asked to rate the quality of movement (QOM) of their more affected arm for 28 activities of daily living. MAL is used to assess changes in participant perspective of arm use in daily life relative to dose of physical therapy.

Secondary Outcomes

  • Stroke Impact Scale (SIS)(Change from Baseline to up to 10 months post-randomization)
  • Upper Extremity Fugl-Meyer (UEFM)(Change from Baseline to up to 10 months post-randomization)

Study Sites (1)

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