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

Ohio State University15 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Stroke Hemiparesis

Interventions

Action Observation + Repetitive Task PracticeBEHAVIORAL

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 PracticeBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

The Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: Pretest, immediately after the intervention, and 1 month post intervention

Secondary Outcomes

Change from Baseline in the The Arm Motor Ability Test

Assessment to evaluate function during activities of daily living of the hemiplegic upper limb

Time frame: Pretest, immediately after the intervention, and 1 month post intervention

Change from Baseline in the Motor Activity Log

Assessment to evaluate the activity limitation of hemiplegic upper limb functional use in the community

Time frame: Pretest, immediately after the intervention, and 1 month post intervention

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

Time frame: Each session (3 times per week) during 8 week intervention

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.

Time frame: Pretest, immediately after the intervention, and 1 month post intervention

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.