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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04015271
• Other study ID #: 2019H0197
• Status: Completed
• Phase: N/A
• Start date: June 27, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

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 Video + Repetitive Task Practice
Observing a video of static images and physically repetitively performing functional task for upper extremity hemiparesis

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pretest, immediately after the intervention, and 1 month post intervention
Secondary	Change from Baseline in the The Arm Motor Ability Test	Assessment to evaluate function during activities of daily living of the hemiplegic upper limb	Pretest, immediately after the intervention, and 1 month post intervention
Secondary	Change from Baseline in the Motor Activity Log	Assessment to evaluate the activity limitation of hemiplegic upper limb functional use in the community	Pretest, immediately after the intervention, and 1 month post intervention
Secondary	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	Each session (3 times per week) during 8 week intervention
Secondary	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.	Pretest, immediately after the intervention, and 1 month post intervention
Secondary	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.	immediately after the intervention, and 1 month post intervention
Secondary	Daily Diary	A diary to measure everyday application of functional tasks learned in the protocol and compliance with HEP	Each day during 8 week intervention
Secondary	Number of trials/ repetitions per task	Measurement of the number of times a subject completes a task in a one hour session	Each session (3 times per week) during 8 week intervention
Secondary	Change in Movement time to complete task	Measure the amount of time required for a subject to complete a task during performance of task	Each session (3 times per week) during 8 week intervention
Secondary	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	Each session (3 times per week) during 8 week intervention
Secondary	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	Each session (3 times per week) during 8 week intervention
Secondary	Change in the number of errors during task performance	Measure the number of errors that a subject demonstrates while performing a task	Each session (3 times per week) during 8 week intervention