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

NCT04015271 | Completed

• 1 other identifier: 2019H0197
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Hemiparesis

Keywords

stroke; hemiparesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change from Baseline in the The Arm Motor Ability Test

  Pretest, immediately after the intervention, and 1 month post intervention

• Change from Baseline in the Motor Activity Log

  Pretest, immediately after the intervention, and 1 month post intervention

• Change from baseline in smoothness of movements measured by three-axis accelerometer

  Each session (3 times per week) during 8 week intervention

• Change from Baseline in Stroke Impact Scale 2.0

  Pretest, immediately after the intervention, and 1 month post intervention

• Survey to assess subjects experience in the study

  immediately after the intervention, and 1 month post intervention

Study Arms (2)

Action Observation + Repetitive Task Practice

EXPERIMENTAL

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.

Behavioral: Action Observation + Repetitive Task Practice

Placebo Video + Repetitive Task Practice

PLACEBO COMPARATOR

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.

Behavioral: Placebo Video + Repetitive Task Practice

Interventions

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

Action Observation + Repetitive Task Practice

Placebo Video + Repetitive Task Practice BEHAVIORAL

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

Placebo Video + Repetitive Task Practice

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 35930301 DERIVED

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

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

Study Officials

• John Buford, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The care provider completing intervention and the outcomes assessor are members of the research team and blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Physical Therapy Division, School of Health and Rehabilitation Sciences

Model Details: A pilot randomized controlled single blinded, parallel-group study design

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 10, 2019
• Study Start: June 27, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)