The Feasibility of Action Observation and Repetitive Task Practice Combined Practice Schedule on Upper Extremity Outcomes in Moderately Impaired Chronic Stroke Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ohio State University
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Change from Baseline in Upper extremity section of the Fugl-Meyer Scale
Study Overview
Brief Summary
The objective of this pilot randomized controlled single blinded, parallel-group study is to detect change of the Action Observation (AO) and Repetitive Task Practice (RTP) combined practice schedule on upper limb motor impairment outcomes in chronic, moderately impaired stroke survivors.
Detailed Description
The current proposal aims to conduct a pilot randomized controlled single blinded, parallel-group study design to detect change of the Action Observation (AO) and Repetitive Task Practice (RTP) combined practice schedule on upper limb (UL) motor impairment outcomes in the chronic, moderately impaired stroke survivor. Individuals will be randomized to 1) experimental conditions of AO + RTP practice schedule, or 2) control condition of Placebo Video (PV) + RTP, and will receive an assigned regimen from a blinded intervention therapist for one hour, 3 times per week, for 8 weeks (total of 24 sessions), and a daily 30 minute HEP. A blinded assessor will complete assessments on each subject at three distinct time points of pretest, post intervention, and 1 month post intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
The care provider completing intervention and the outcomes assessor are members of the research team and blinded to group assignment.
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Experienced a stroke resulting in a Upper Extremity Fugl Meyer score >17 < 49
- •Experienced a post stroke > 6 months
- •> 24 on the Folstein Mini Mental Status Examination
- •Experienced only one stroke
- •Discharged from all forms of physical rehabilitation intervention
- •Visual acuity of 20/50 or greater with or without corrective lenses
- •> 19 on the Hooper Visual Organization Test
- •Unilateral stroke only
- •Cerebral stroke
- •Age of onset of stroke greater than 18 years old.
Exclusion Criteria
- •< 18 years old
- •> 5 on a 10-point visual analog pain scale in the affected UL
- •> 2 on the Modified Ashworth Scale in the affected UL to exclude individuals with hypertonia, spasticity, joint rigidity, and joint contracture
- •Participating in any experimental rehabilitation or drug studies
- •Uncontrolled cardiovascular, or pulmonary disease, or other disease that would preclude involvement in a therapeutic treatment
- •Neurological disorder other than stroke
- •> 31 on Beck Depression Inventory ("Severe Depression")
- •Unable to regularly attend treatment sessions and follow-up due to distance from the center or inadequate social support
- •Cerebellar stroke with ataxia
Outcomes
Primary Outcomes
Change from Baseline in Upper extremity section of the Fugl-Meyer Scale
Time Frame: Pretest, immediately after the intervention, and 1 month post intervention
Assessment to evaluate motor impairment of the hemiplegic upper limb. Multiple time points will be used to asses the change in motor impairment. Items are scored on a 3 point ordinal scale (0 = cannot perform, 2 = can perform fully), and are totaled for a maximum of 66 possible points.
Secondary Outcomes
- Change from baseline in smoothness of movements measured by three-axis accelerometer(Each session (3 times per week) during 8 week intervention)
- Change from Baseline in Stroke Impact Scale 2.0(Pretest, immediately after the intervention, and 1 month post intervention)
- Change from Baseline in the The Arm Motor Ability Test(Pretest, immediately after the intervention, and 1 month post intervention)
- Daily Diary(Each day during 8 week intervention)
- Change in Amount of physical assist to perform task(Each session (3 times per week) during 8 week intervention)
- Change from Baseline in the Motor Activity Log(Pretest, immediately after the intervention, and 1 month post intervention)
- Change in Movement time to complete task(Each session (3 times per week) during 8 week intervention)
- Survey to assess subjects experience in the study(immediately after the intervention, and 1 month post intervention)
- Number of trials/ repetitions per task(Each session (3 times per week) during 8 week intervention)
- Change in Number of verbal cues given to perform task(Each session (3 times per week) during 8 week intervention)
- Change in the number of errors during task performance(Each session (3 times per week) during 8 week intervention)
Investigators
John Buford, PT, PhD
Professor and Director of Physical Therapy Division, School of Health and Rehabilitation Sciences
Ohio State University