Dose Optimization for Stroke Evaluation

Stroke Clinical Trial

— DOSE  

Official title:

Optimizing the Dose of Rehabilitation After Stroke.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749358
• Other study ID #: R01HD065438
• Secondary ID: R01HD065438
• Status: Completed
• Phase: Phase 1
• First received: June 25, 2012
• Last updated: April 4, 2017
• Start date: March 2012
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebrovascular Disorders
• Infarction
• Ischemia
• Stroke

Intervention

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. Any therapy received while in this group will be dosed according to usual and customary practice.

Locations

Country	Name	City	State
United States	University of Southern California-Health Sciences Campus	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	Change from Baseline to up to 4 months post-randomization
Secondary	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.	Change from Baseline to up to 4 months post-randomization
Secondary	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.	Change from Baseline to up to 10 months post-randomization
Secondary	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.	Change from Baseline to up to 10 months post-randomization