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OpenTrials
Completed

NCT Number: NCT01749358

Dose Optimization for Stroke Evaluation

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.

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Key information

Conditions

Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Neurologic Manifestations Paresis Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Southern California-Health Sciences Campus

Los Angeles, California, 90089, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Accelerated Skill Acquisition Program (ASAP)

Behavioral

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

Behavioral

This is an observation-only group. Any therapy received while in this group will be dosed according to usual and customary practice.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

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

Registry information

Official study title

Optimizing the Dose of Rehabilitation After Stroke.

Acronym: DOSE

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 13, 2012
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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