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Completed

NCT Number: NCT04015271

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiparesis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Action Observation + Repetitive Task Practice

Behavioral

Observing a video of another person performing a functional task and physically repetitively performing the same task for upper extremity hemiparesis

Placebo Video + Repetitive Task Practice

Behavioral

Observing a video of static images and physically repetitively performing functional task for upper extremity hemiparesis

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

The Feasibility of Action Observation and Repetitive Task Practice Combined Practice Schedule on Upper Extremity Outcomes in Moderately Impaired Chronic Stroke Survivors

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 10, 2019
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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