Clinical trial NCT04015271: Feasibility of Action Observation and Repetitive Task Practice on Upper Extremity Outcomes in Chronic Stroke Survivors
Official title: The Feasibility of Action Observation and Repetitive Task Practice Combined Practice Schedule on Upper Extremity Outcomes in Moderately Impaired Chronic Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis
Keywords: stroke
hemiparesis
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot randomized controlled single blinded, parallel-group study design
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Upper extremity section of the Fugl-Meyer Scale
timeFrame: Pretest, immediately after the intervention, and 1 month post intervention
Secondary outcomes:
measure: Change from Baseline in the The Arm Motor Ability Test
timeFrame: Pretest, immediately after the intervention, and 1 month post intervention
measure: Change from Baseline in the Motor Activity Log
timeFrame: Pretest, immediately after the intervention, and 1 month post intervention
measure: Change from baseline in smoothness of movements measured by three-axis accelerometer
timeFrame: Each session (3 times per week) during 8 week intervention
measure: Change from Baseline in Stroke Impact Scale 2.0
timeFrame: Pretest, immediately after the intervention, and 1 month post intervention
measure: Survey to assess subjects experience in the study
timeFrame: immediately after the intervention, and 1 month post intervention
measure: Daily Diary
timeFrame: Each day during 8 week intervention
measure: Number of trials/ repetitions per task
timeFrame: Each session (3 times per week) during 8 week intervention
measure: Change in Movement time to complete task
timeFrame: Each session (3 times per week) during 8 week intervention
measure: Change in Amount of physical assist to perform task
timeFrame: Each session (3 times per week) during 8 week intervention
measure: Change in Number of verbal cues given to perform task
timeFrame: Each session (3 times per week) during 8 week intervention
measure: Change in the number of errors during task performance
timeFrame: Each session (3 times per week) during 8 week intervention
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: John Buford, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.