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

The Ohio State University

Status: Completed

Conditions: Stroke; Hemiparesis

Treatments: Behavioral: Action Observation + Repetitive Task Practice; Behavioral: Placebo Video + Repetitive Task Practice

Study type: Interventional

Funder types: Other

Identifiers

NCT04015271

2019H0197

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups, including a placebo group

Action Observation + Repetitive Task Practice

Experimental group

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.

Treatment:

Behavioral: Action Observation + Repetitive Task Practice

Placebo Video + Repetitive Task Practice

Placebo Comparator group

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.

Treatment:

Behavioral: Placebo Video + Repetitive Task Practice