Dose Optimization for Stroke Evaluation

NCT01749358 | Completed Phase 1

• 1 other identifier: R01HD065438
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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.

  Change from Baseline to up to 4 months post-randomization

• 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.

  Change from Baseline to up to 4 months post-randomization

• 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.

  Change from Baseline to up to 4 months post-randomization

• 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.

  Change from Baseline to up to 10 months post-randomization

• 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.

  Change from Baseline to up to 10 months post-randomization

• 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.

  Change from Baseline to up to 10 months post-randomization

Secondary Outcomes (4)

• Stroke Impact Scale (SIS)

  Change from Baseline to up to 4 months post-randomization

• Upper Extremity Fugl-Meyer (UEFM)

  Change from Baseline to up to 4 months post-randomization

• Stroke Impact Scale (SIS)

  Change from Baseline to up to 10 months post-randomization

• Upper Extremity Fugl-Meyer (UEFM)

  Change from Baseline to up to 10 months post-randomization

Study Arms (4)

High Therapy Dose

EXPERIMENTAL

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)

Moderate Therapy Dose

EXPERIMENTAL

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)

Low Therapy Dose

EXPERIMENTAL

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)

Active Monitoring

OTHER

This is an observation only group.

Behavioral: Active Monitoring

Interventions

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.

High Therapy Dose; Low Therapy Dose; Moderate Therapy Dose

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.

Active Monitoring

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Southern California-Health Sciences Campus

Los Angeles, California, 90089, United States

Location

Related Publications (2)

• Schweighofer N, Ye D, Luo H, D'Argenio DZ, Winstein C. Long-term forecasting of a motor outcome following rehabilitation in chronic stroke via a hierarchical bayesian dynamic model. J Neuroeng Rehabil. 2023 Jun 29;20(1):83. doi: 10.1186/s12984-023-01202-y.

  PMID: 37386512 DERIVED

• 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.

  PMID: 31164067 DERIVED

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders; Brain Ischemia; Infarction; Paresis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Carolee Winstein, PhD, PT, FAPTA

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Nicolas Schweighofer, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Clarisa Martinez, PT, DPT

  University of Southern California

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: December 13, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 6, 2017

Record last verified: 2016-10

Locations

US (1)