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出境医 / 临床实验 / Feasibility of Action Observation and Repetitive Task Practice on Upper Extremity Outcomes in Chronic Stroke Survivors

Feasibility of Action Observation and Repetitive Task Practice on Upper Extremity Outcomes in Chronic Stroke Survivors

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.

Condition or disease Intervention/treatment Phase
Stroke Hemiparesis Behavioral: Action Observation + Repetitive Task Practice Behavioral: Placebo Video + Repetitive Task Practice Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A pilot randomized controlled single blinded, parallel-group study design
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.
Primary Purpose: Treatment
Official Title: The Feasibility of Action Observation and Repetitive Task Practice Combined Practice Schedule on Upper Extremity Outcomes in Moderately Impaired Chronic Stroke Survivors
Actual Study Start Date : June 27, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Action Observation + Repetitive Task Practice
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.
 Behavioral: Action 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
Placebo Comparator: Placebo Video + Repetitive Task Practice
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.
 Behavioral: Placebo Video + Repetitive Task Practice
Observing a video of static images and physically repetitively performing functional task for upper extremity hemiparesis
Outcome Measures
Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from Baseline in the The Arm Motor Ability Test [ Time Frame: Pretest, immediately after the intervention, and 1 month post intervention ]
    Assessment to evaluate function during activities of daily living of the hemiplegic upper limb

  2. Change from Baseline in the Motor Activity Log [ Time Frame: 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

  3. Change from baseline in smoothness of movements measured by three-axis accelerometer [ Time Frame: 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

  4. Change from Baseline in Stroke Impact Scale 2.0 [ Time Frame: 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.

  5. Survey to assess subjects experience in the study [ Time Frame: 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.

  6. Daily Diary [ Time Frame: Each day during 8 week intervention ]
    A diary to measure everyday application of functional tasks learned in the protocol and compliance with HEP

  7. Number of trials/ repetitions per task [ Time Frame: 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

  8. Change in Movement time to complete task [ Time Frame: 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

  9. Change in Amount of physical assist to perform task [ Time Frame: 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

  10. Change in Number of verbal cues given to perform task [ Time Frame: 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

  11. Change in the number of errors during task performance [ Time Frame: Each session (3 times per week) during 8 week intervention ]
    Measure the number of errors that a subject demonstrates while performing a task


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Layout table for investigator information
Principal Investigator: John Buford, PhD Ohio State University
Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date March 4, 2020
Actual Study Start Date  ICMJE June 27, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Change from Baseline in the The Arm Motor Ability Test [ Time Frame: 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 [ Time Frame: 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 smoothness of movements measured by three-axis accelerometer [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Each day during 8 week intervention ]
    A diary to measure everyday application of functional tasks learned in the protocol and compliance with HEP
  • Number of trials/ repetitions per task [ Time Frame: 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 Movement time to complete task [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Each session (3 times per week) during 8 week intervention ]
    Measure the number of errors that a subject demonstrates while performing a task
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of Action Observation and Repetitive Task Practice on Upper Extremity Outcomes in Chronic Stroke Survivors
Official Title  ICMJE The Feasibility of Action Observation and Repetitive Task Practice Combined Practice Schedule on Upper Extremity Outcomes in Moderately Impaired Chronic Stroke Survivors
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A pilot randomized controlled single blinded, parallel-group study design
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.
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Hemiparesis
Intervention  ICMJE
  • Behavioral: Action 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
  • Behavioral: Placebo Video + Repetitive Task Practice
    Observing a video of static images and physically repetitively performing functional task for upper extremity hemiparesis
Study Arms  ICMJE
  • Experimental: Action Observation + Repetitive Task Practice
    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.
    Intervention: Behavioral: Action Observation + Repetitive Task Practice
  • Placebo Comparator: Placebo Video + Repetitive Task Practice
    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: Behavioral: Placebo Video + Repetitive Task Practice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2019) 		15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04015271
Other Study ID Numbers  ICMJE 2019H0197
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party John Buford, PT, PhD, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Buford, PhD Ohio State University
PRS Account Ohio State University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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