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Dose Optimization for Stroke Evaluation (DOSE)

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Carolee Winstein, University of Southern California
ClinicalTrials.gov Identifier:
NCT01749358
First received: June 25, 2012
Last updated: April 4, 2017
Last verified: October 2016
  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: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Optimizing the Dose of Rehabilitation After Stroke.

Resource links provided by NLM:


Further study details as provided by Carolee Winstein, University of Southern California:

Primary Outcome Measures:
  • Bilateral Arm Reaching Test (BART) [ Time Frame: Change from Baseline to up to 4 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 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 ]
    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 ]
    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 ]
    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 Outcome Measures:
  • Stroke Impact Scale (SIS) [ Time Frame: Change from Baseline to up to 4 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) [ Time Frame: Change from Baseline to up to 4 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.

  • Stroke Impact Scale (SIS) [ Time Frame: 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) [ Time Frame: 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.


Enrollment: 60
Study Start Date: March 2012
Study Completion Date: August 2016
Primary Completion Date: August 2016 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
University of Southern California-Health Sciences Campus
Los Angeles, California, United States, 90089
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

Responsible Party: Carolee Winstein, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT01749358     History of Changes
Other Study ID Numbers: R01HD065438 ( US NIH Grant/Contract Award Number )
Study First Received: June 25, 2012
Last Updated: April 4, 2017

Keywords provided by Carolee Winstein, 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:
Stroke
Infarction
Ischemia
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on June 22, 2017