Dose Optimization for Stroke Evaluation - Full Text View

Purpose

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.

Condition	Intervention	Phase
Stroke Cerebrovascular Disorders Brain Ischemia Infarction	Behavioral: Accelerated Skill Acquisition Program (ASAP) Behavioral: Active Monitoring	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Optimizing the Dose of Rehabilitation After Stroke.

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Further study details as provided by University of Southern California:

Primary Outcome Measures:

Bilateral Arm Reaching Test (BART) [ Time Frame: Change from Baseline to up to 4 months post-randomization ] [ Designated as safety issue: No ]
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 two times per month for the four months following randomization, and one time a month for 6 months during the follow-up period 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 4 months post-randomization ] [ Designated as safety issue: No ]
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 4 months post-randomization ] [ Designated as safety issue: No ]
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.
Bilateral Arm Reaching Test (BART) [ Time Frame: Change from Baseline to up to 10 months post-randomization ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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:

Stroke Impact Scale (SIS) [ Time Frame: Change from Baseline to up to 4 months post-randomization ] [ Designated as safety issue: No ]
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) [ Time Frame: Change from Baseline to up to 4 months post-randomization ] [ Designated as safety issue: No ]
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.
Stroke Impact Scale (SIS) [ Time Frame: Change from Baseline to up to 10 months post-randomization ] [ Designated as safety issue: No ]
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) [ Time Frame: Change from Baseline to up to 10 months post-randomization ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	60
Study Start Date:	March 2012
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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).	Behavioral: 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.
Experimental: 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).	Behavioral: 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.
Experimental: 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).	Behavioral: 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.	Behavioral: 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

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749358

Contacts

Contact: Clarisa Martinez, PT, DPT	323-442-1410	clarisa@usc.edu
Contact: Carolee Winstein, PhD,PT,FAPTA	323-442-2903	winstein@usc.edu

Locations

United States, California
University of Southern California-Health Sciences Campus	Recruiting
Los Angeles, California, United States, 90089
Contact: Clarisa Martinez, PT, DPT 323-442-1410 clarisa@usc.edu
Principal Investigator: Carolee Winstein, PhD, PT, FAPTA
Principal Investigator: Nicolas Schweighofer, PhD

Sponsors and Collaborators

University of Southern California

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:	Carolee Winstein, PhD, PT, FAPTA	University of Southern California
Principal Investigator:	Nicolas Schweighofer, PhD	University of Southern California
Study Director:	Clarisa Martinez, PT, DPT	University of Southern California

More Information

No publications provided

Responsible Party:	University of Southern California
ClinicalTrials.gov Identifier:	NCT01749358 History of Changes
Other Study ID Numbers:	R01 HD065438, R01HD065438
Study First Received:	June 25, 2012
Last Updated:	December 11, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Southern California:

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

Additional relevant MeSH terms:

Cerebrovascular Disorders
Brain Ischemia
Infarction
Ischemia
Stroke
Cerebral Infarction
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis
Brain Infarction

ClinicalTrials.gov processed this record on May 16, 2013

Dose Optimization for Stroke Evaluation (DOSE)