Clinical trial NCT01749358: Dose Optimization for Stroke Evaluation
Official title: Optimizing the Dose of Rehabilitation After Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Cerebrovascular Disorders
Brain Ischemia
Infarction
Keywords: stroke
hemiparesis
physical therapy
occupational therapy
neurorehabilitation
patient focused
motor learning
motor control
skill acquisition
skill training
motor recovery
task oriented training
task specific training
arm function
hand function
upper extremity
arm therapy
physical rehabilitation
arm rehabilitation
motor function
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2012-12-13
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

* Ischemic or hemorrhagic stroke that occured at least 6 months ago.
* 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:

* Severe upper extremity sensory impairment
* 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.

Primary outcomes:
measure: Bilateral Arm Reaching Test (BART)
timeFrame: Change from Baseline to up to 4 months post-randomization
measure: Wolf Motor Function Test (WMFT)
timeFrame: Change from Baseline to up to 4 months post-randomization
measure: Motor Activity Log (MAL)
timeFrame: Change from Baseline to up to 4 months post-randomization
measure: Bilateral Arm Reaching Test (BART)
timeFrame: Change from Baseline to up to 10 months post-randomization
measure: Wolf Motor Function Test (WMFT)
timeFrame: Change from Baseline to up to 10 months post-randomization
measure: Motor Activity Log (MAL)
timeFrame: Change from Baseline to up to 10 months post-randomization
Secondary outcomes:
measure: Stroke Impact Scale (SIS)
timeFrame: Change from Baseline to up to 4 months post-randomization
measure: Upper Extremity Fugl-Meyer (UEFM)
timeFrame: Change from Baseline to up to 4 months post-randomization
measure: Stroke Impact Scale (SIS)
timeFrame: Change from Baseline to up to 10 months post-randomization
measure: Upper Extremity Fugl-Meyer (UEFM)
timeFrame: Change from Baseline to up to 10 months post-randomization
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California-Health Sciences Campus
state: California
Study officials:
affiliation: University of Southern California
name: Carolee Winstein, PhD, PT, FAPTA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Nicolas Schweighofer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Clarisa Martinez, PT, DPT
role: STUDY_DIRECTOR
References:
citation: 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.