Dose Optimization for Stroke Evaluation (DOSE)

April 4, 2017 updated by: Carolee Winstein, University of Southern California

Optimizing the Dose of Rehabilitation After Stroke.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline to up to 4 months post-randomization
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.
Change from Baseline to up to 4 months post-randomization
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.
Change from Baseline to up to 4 months post-randomization
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.
Change from Baseline to up to 10 months post-randomization
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.
Change from Baseline to up to 10 months post-randomization
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.
Change from Baseline to up to 10 months post-randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline to up to 4 months post-randomization
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.
Change from Baseline to up to 4 months post-randomization
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.
Change from Baseline to up to 10 months post-randomization
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.
Change from Baseline to up to 10 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

December 11, 2012

First Posted (Estimate)

December 13, 2012

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HD065438 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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