Back to resultsFeasibility of Action Observation and Repetitive Task Practice on Upper Extremity Outcomes in Chronic Stroke Survivors
Primary Purpose
Stroke, Hemiparesis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Action Observation + Repetitive Task Practice
Placebo Video + Repetitive Task Practice
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, hemiparesis
Eligibility Criteria
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
Sites / Locations
- The Ohio State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Action Observation + Repetitive Task Practice
Placebo Video + Repetitive Task Practice
Arm Description
Action Observation (AO) therapy regimen will include watching a 6 minute video of another person completing a specified functional task (Putting on a shirt, pick up a sandwich and bring to mouth, eat food with a spoon, or cut meat with knife and fork). Subjects will be instructed to carefully watch the AO video and prepare to physically perform the task immediately after observing the video. The Repetitive Task Practice (RTP) therapy regimen emphasizes repeated physical performance with the hemiplegic upper limb for 24 minutes of a specified functional task that is matched to the AO recording. The AO + RTP regimens will be repeated for a total of 60 minutes. Each Subject will complete a Home Exercise Program (HEP) will include practicing components and movement patterns of the functional task that was difficult for the patient to perform during RTP intervention for 30 minutes each day outside of scheduled intervention sessions.
The control placebo videos (PV) will be 6 minutes, and will include a series of changing static images without animals, human beings, or sound (i.e. pictures of buildings, trees, cruise ships, mountains, beach umbrellas, beds, and tables). A Repetitive Task Practice (RTP) therapy regimen will be completed immediately after observing the PV, which emphasizes repeated physical performance with the hemiplegic upper limb for 24 minutes of a specified functional task. These tasks include putting on a shirt, picking up a sandwich and bringing it to mouth, eating food with a spoon, or cutting meat with knife and fork. The PV + RTP regimens will be repeated for a total of 60 minutes. Each Subject will complete a Home Exercise Program (HEP) will include practicing components and movement patterns of the functional task that was difficult for the patient to perform during RTP intervention for 30 minutes each day outside of scheduled intervention sessions.
Outcomes
Primary Outcome Measures
Change from Baseline in Upper extremity section of the Fugl-Meyer Scale
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
Change from Baseline in the The Arm Motor Ability Test
Assessment to evaluate function during activities of daily living of the hemiplegic upper limb
Change from Baseline in the Motor Activity Log
Assessment to evaluate the activity limitation of hemiplegic upper limb functional use in the community
Change from baseline in smoothness of movements measured by three-axis accelerometer
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
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
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
A diary to measure everyday application of functional tasks learned in the protocol and compliance with HEP
Number of trials/ repetitions per task
Measurement of the number of times a subject completes a task in a one hour session
Change in Movement time to complete task
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
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
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
Measure the number of errors that a subject demonstrates while performing a task
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04015271
Brief Title
Feasibility of Action Observation and Repetitive Task Practice on Upper Extremity Outcomes in Chronic Stroke Survivors
Official Title
The Feasibility of Action Observation and Repetitive Task Practice Combined Practice Schedule on Upper Extremity Outcomes in Moderately Impaired Chronic Stroke Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
stroke, hemiparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A pilot randomized controlled single blinded, parallel-group study design
Masking
Care ProviderOutcomes Assessor
Masking Description
The care provider completing intervention and the outcomes assessor are members of the research team and blinded to group assignment.
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Action Observation + Repetitive Task Practice
Arm Type
Experimental
Arm Description
Action Observation (AO) therapy regimen will include watching a 6 minute video of another person completing a specified functional task (Putting on a shirt, pick up a sandwich and bring to mouth, eat food with a spoon, or cut meat with knife and fork). Subjects will be instructed to carefully watch the AO video and prepare to physically perform the task immediately after observing the video. The Repetitive Task Practice (RTP) therapy regimen emphasizes repeated physical performance with the hemiplegic upper limb for 24 minutes of a specified functional task that is matched to the AO recording. The AO + RTP regimens will be repeated for a total of 60 minutes. Each Subject will complete a Home Exercise Program (HEP) will include practicing components and movement patterns of the functional task that was difficult for the patient to perform during RTP intervention for 30 minutes each day outside of scheduled intervention sessions.
Arm Title
Placebo Video + Repetitive Task Practice
Arm Type
Placebo Comparator
Arm Description
The control placebo videos (PV) will be 6 minutes, and will include a series of changing static images without animals, human beings, or sound (i.e. pictures of buildings, trees, cruise ships, mountains, beach umbrellas, beds, and tables). A Repetitive Task Practice (RTP) therapy regimen will be completed immediately after observing the PV, which emphasizes repeated physical performance with the hemiplegic upper limb for 24 minutes of a specified functional task. These tasks include putting on a shirt, picking up a sandwich and bringing it to mouth, eating food with a spoon, or cutting meat with knife and fork. The PV + RTP regimens will be repeated for a total of 60 minutes. Each Subject will complete a Home Exercise Program (HEP) will include practicing components and movement patterns of the functional task that was difficult for the patient to perform during RTP intervention for 30 minutes each day outside of scheduled intervention sessions.
Intervention Type
Behavioral
Intervention Name(s)
Action Observation + Repetitive Task Practice
Intervention Description
Observing a video of another person performing a functional task and physically repetitively performing the same task for upper extremity hemiparesis
Intervention Type
Behavioral
Intervention Name(s)
Placebo Video + Repetitive Task Practice
Intervention Description
Observing a video of static images and physically repetitively performing functional task for upper extremity hemiparesis
Primary Outcome Measure Information:
Title
Change from Baseline in Upper extremity section of the Fugl-Meyer Scale
Description
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.
Time Frame
Pretest, immediately after the intervention, and 1 month post intervention
Secondary Outcome Measure Information:
Title
Change from Baseline in the The Arm Motor Ability Test
Description
Assessment to evaluate function during activities of daily living of the hemiplegic upper limb
Time Frame
Pretest, immediately after the intervention, and 1 month post intervention
Title
Change from Baseline in the Motor Activity Log
Description
Assessment to evaluate the activity limitation of hemiplegic upper limb functional use in the community
Time Frame
Pretest, immediately after the intervention, and 1 month post intervention
Title
Change from baseline in smoothness of movements measured by three-axis accelerometer
Description
A Fitbit will be used to quantify the amount of upper limb motor activity during an intervention session and heart rate
Time Frame
Each session (3 times per week) during 8 week intervention
Title
Change from Baseline in Stroke Impact Scale 2.0
Description
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.
Time Frame
Pretest, immediately after the intervention, and 1 month post intervention
Title
Survey to assess subjects experience in the study
Description
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.
Time Frame
immediately after the intervention, and 1 month post intervention
Title
Daily Diary
Description
A diary to measure everyday application of functional tasks learned in the protocol and compliance with HEP
Time Frame
Each day during 8 week intervention
Title
Number of trials/ repetitions per task
Description
Measurement of the number of times a subject completes a task in a one hour session
Time Frame
Each session (3 times per week) during 8 week intervention
Title
Change in Movement time to complete task
Description
Measure the amount of time required for a subject to complete a task during performance of task
Time Frame
Each session (3 times per week) during 8 week intervention
Title
Change in Amount of physical assist to perform task
Description
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
Time Frame
Each session (3 times per week) during 8 week intervention
Title
Change in Number of verbal cues given to perform task
Description
Measure the number of verbal cues that are required for a subject to perform a task
Time Frame
Each session (3 times per week) during 8 week intervention
Title
Change in the number of errors during task performance
Description
Measure the number of errors that a subject demonstrates while performing a task
Time Frame
Each session (3 times per week) during 8 week intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Buford, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35930301
Citation
Borges LR, Fernandes AB, Oliveira Dos Passos J, Rego IAO, Campos TF. Action observation for upper limb rehabilitation after stroke. Cochrane Database Syst Rev. 2022 Aug 5;8(8):CD011887. doi: 10.1002/14651858.CD011887.pub3.
Results Reference
derived
Learn more about this trial
Feasibility of Action Observation and Repetitive Task Practice on Upper Extremity Outcomes in Chronic Stroke Survivors
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