Hemiparesis, Stroke
Conditions
Keywords
stroke, hemiparesis
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.
Interventions
BEHAVIORALAction Observation + Repetitive Task Practice
Observing a video of another person performing a functional task and physically repetitively performing the same task for upper extremity hemiparesis
BEHAVIORALPlacebo Video + Repetitive Task Practice
Observing a video of static images and physically repetitively performing functional task for upper extremity hemiparesis
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The care provider completing intervention and the outcomes assessor are members of the research team and blinded to group assignment.
Intervention model description
A pilot randomized controlled single blinded, parallel-group study design
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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. |
| 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. |
| 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 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 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 |
| 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 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 |
| 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 |
Countries
United States
Outcome results
None listed