Dose Optimization for Stroke Evaluation

Phase 1

Completed

• Conditions: Stroke; Brain Ischemia; Cerebrovascular Disorders; Infarction

• Registration Number: NCT01749358
• Lead Sponsor: University of Southern California

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-13
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-10
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bilateral Arm Reaching Test (BART)	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)	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)	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 Outcome Measures

Name	Time	Method
Stroke Impact Scale (SIS)	Change from Baseline to up to 10 months post-randomization	A self-report measure to assess the ways in which an individual's health and life are impacted after a stroke. SIS will be used to assess changes in participant self-report of the impact of the stroke on health and life relative to dosage of physical therapy.
Upper Extremity Fugl-Meyer (UEFM)	Change from Baseline to up to 10 months post-randomization	A test of motor function and sensation for the arm that is most affected by the stroke. UEFM will assess change in motor function relative to dose of physical therapy.

Trial Locations

Locations (1)

University of Southern California-Health Sciences Campus; 🇺🇸 Los Angeles, California, United States