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

NCT ID: NCT04015271

Last Updated: 2020-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-27

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Stroke Hemiparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A pilot randomized controlled single blinded, parallel-group study design
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
The care provider completing intervention and the outcomes assessor are members of the research team and blinded to group assignment.

Study Groups

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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.

Group Type EXPERIMENTAL

Action Observation + Repetitive Task Practice

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Placebo Video + Repetitive Task Practice

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Placebo Video + Repetitive Task Practice

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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John Buford, PT, PhD

Professor and Director of Physical Therapy Division, School of Health and Rehabilitation Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Buford, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35930301 (View on PubMed)

Other Identifiers

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2019H0197

Identifier Type: -

Identifier Source: org_study_id

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