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Dose Optimization for Stroke Evaluation (DOSE)

Primary Purpose

Stroke, Cerebrovascular Disorders, Brain Ischemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Accelerated Skill Acquisition Program (ASAP)
Active Monitoring
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring 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

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Southern California-Health Sciences Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

High Therapy Dose

Moderate Therapy Dose

Low Therapy Dose

Active Monitoring

Arm Description

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).

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).

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).

This is an observation only group.

Outcomes

Primary Outcome Measures

Bilateral Arm Reaching Test (BART)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.

Full Information

First Posted
June 25, 2012
Last Updated
April 4, 2017
Sponsor
University of Southern California
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01749358
Brief Title
Dose Optimization for Stroke Evaluation
Acronym
DOSE
Official Title
Optimizing the Dose of Rehabilitation After Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Therapy Dose
Arm Type
Experimental
Arm Description
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).
Arm Title
Moderate Therapy Dose
Arm Type
Experimental
Arm Description
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).
Arm Title
Low Therapy Dose
Arm Type
Experimental
Arm Description
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).
Arm Title
Active Monitoring
Arm Type
Other
Arm Description
This is an observation only group.
Intervention Type
Behavioral
Intervention Name(s)
Accelerated Skill Acquisition Program (ASAP)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Monitoring
Intervention Description
This is an observation-only group. Any therapy received while in this group will be dosed according to usual and customary practice.
Primary Outcome Measure Information:
Title
Bilateral Arm Reaching Test (BART)
Description
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.
Time Frame
Change from Baseline to up to 4 months post-randomization
Title
Wolf Motor Function Test (WMFT)
Description
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.
Time Frame
Change from Baseline to up to 4 months post-randomization
Title
Motor Activity Log (MAL)
Description
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.
Time Frame
Change from Baseline to up to 4 months post-randomization
Title
Bilateral Arm Reaching Test (BART)
Description
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.
Time Frame
Change from Baseline to up to 10 months post-randomization
Title
Wolf Motor Function Test (WMFT)
Description
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.
Time Frame
Change from Baseline to up to 10 months post-randomization
Title
Motor Activity Log (MAL)
Description
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.
Time Frame
Change from Baseline to up to 10 months post-randomization
Secondary Outcome Measure Information:
Title
Stroke Impact Scale (SIS)
Description
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.
Time Frame
Change from Baseline to up to 4 months post-randomization
Title
Upper Extremity Fugl-Meyer (UEFM)
Description
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.
Time Frame
Change from Baseline to up to 4 months post-randomization
Title
Stroke Impact Scale (SIS)
Description
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.
Time Frame
Change from Baseline to up to 10 months post-randomization
Title
Upper Extremity Fugl-Meyer (UEFM)
Description
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.
Time Frame
Change from Baseline to up to 10 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolee Winstein, PhD, PT, FAPTA
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicolas Schweighofer, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Clarisa Martinez, PT, DPT
Organizational Affiliation
University of Southern California
Official's Role
Study Director
Facility Information:
Facility Name
University of Southern California-Health Sciences Campus
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31164067
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.
Results Reference
derived

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Dose Optimization for Stroke Evaluation

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