Feasibility of Action Observation and Repetitive Task Practice on Upper Extremity Outcomes in Chronic Stroke Survivors
- Conditions
- HemiparesisStroke
- Registration Number
- NCT04015271
- Lead Sponsor
- Ohio State University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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.
- < 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from Baseline in Upper extremity section of the Fugl-Meyer Scale 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 Outcome Measures
Name Time Method Change from baseline in smoothness of movements measured by three-axis accelerometer Each session (3 times per week) during 8 week intervention A Fitbit will be used to quantify the amount of upper limb motor activity during an intervention session and heart rate
Change from Baseline in Stroke Impact Scale 2.0 Pretest, immediately after the intervention, and 1 month post intervention Assessment to evaluate motor and functional changes in the hemiplegic upper. It is a 64-item self-report measure assessing 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation).A low score indicates a high impact on quality of life.
Change from Baseline in the The Arm Motor Ability Test Pretest, immediately after the intervention, and 1 month post intervention Assessment to evaluate function during activities of daily living of the hemiplegic upper limb
Daily Diary Each day during 8 week intervention A diary to measure everyday application of functional tasks learned in the protocol and compliance with HEP
Change in Amount of physical assist to perform task Each session (3 times per week) during 8 week intervention Measure how much assistance a subject requires to complete a task. Amount will be measured in the categories of tactile cue, 1 hand assistance, 2 hand assistance
Change from Baseline in the Motor Activity Log Pretest, immediately after the intervention, and 1 month post intervention Assessment to evaluate the activity limitation of hemiplegic upper limb functional use in the community
Change in Movement time to complete task Each session (3 times per week) during 8 week intervention Measure the amount of time required for a subject to complete a task during performance of task
Survey to assess subjects experience in the study immediately after the intervention, and 1 month post intervention A survey to examine the perceived experience of the intervention for subjects participating in the study. Subjects will answer on a 5 point ordinal scale (1 = Strongly disagree, 5 = Strongly Agree), and open ended questions will be descriptive questions to explain response on ordinal scale.
Number of trials/ repetitions per task Each session (3 times per week) during 8 week intervention Measurement of the number of times a subject completes a task in a one hour session
Change in Number of verbal cues given to perform task Each session (3 times per week) during 8 week intervention Measure the number of verbal cues that are required for a subject to perform a task
Change in the number of errors during task performance Each session (3 times per week) during 8 week intervention Measure the number of errors that a subject demonstrates while performing a task
Trial Locations
- Locations (1)
The Ohio State University
🇺🇸Columbus, Ohio, United States
The Ohio State University🇺🇸Columbus, Ohio, United States