Action Observation, Imagery and Execution for Stroke Rehabilitation

Action Observation, Imagery and Execution as a New Intervention Strategy for Stroke Rehabilitation: Short- and Long-term Treatment Effects and Neural Mechanism

The specific study aims will be:

1. To investigate the short- and long-term treatment effects of action observation, imagery, and execution therapy (AOIE) compared with an action observation therapy (AO) group and a control treatment group as controls on different aspects of outcomes in patients with stroke.
2. To examine the neural mechanisms and changes in cortical neural activity after the interventions in stroke patients.
3. To examine the correlations between AOIE-induced brain activation changes and the clinical efficacy of AOIE.
4. To identify who are the possible good responders to the therapy based on baseline motor function and motor imagery ability of the participants.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Action observation, imagery & execution; Behavioral: Action observation; Behavioral: Control treatment

Detailed Description

The investigators propose a 3-year randomized controlled trial to (1) investigate the short- and long-term treatment efficacy of AOIE, action observation alone, versus control treatment on clinical outcomes of patients with subacute stroke, (2) examine the neural mechanisms and activation changes after the 3 interventions by using an advanced brain imaging technique, magnetoencephalography (MEG), (3) determine the correlations between neural activation changes and clinical outcomes, and (4) identify who are the good responders to the AOIE therapy. An estimated total of 96 patients with subacute stroke will be recruited in this study. All participants will be randomly assigned to receive 1 of the 3 interventions for 3 weeks (a total of 15 sessions). Clinical outcome measures will be conducted at baseline, immediately after treatment (3 weeks), and at 3 months follow-up. The MEG assessment will be conducted at baseline and immediately after treatment (3 weeks). For the MEG study, The investigators anticipate to enroll 12 to 15 patients in each group to complete neuroimaging evaluation because of the specific eligibility criteria and high costs of MEG. The patients can still participate in the study, receiving rehabilitation therapy and clinical evaluations, even if the participants will not be included in the MEG study.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University Hospital
  • Taipei, Taiwan, 23561
    • Taipei Medical University Shuang Ho Hospital
  • Taoyuan City, Taiwan, 333
    • Taoyuan Chang Gung Memorial Hospital
  • Taoyuan City, Taiwan, 3351
    • Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosed as having a unilateral stroke;
• 1 to 12 months after stroke onset
• from 20 to 80 years of age
• a baseline score of the Fugl-Meyer Assessment (FMA) of 20 to 60
• able to follow the study instructions
• capable of participating in therapy and assessment sessions.

Exclusion Criteria:

• patients with global or receptive aphasia,
• severe neglect
• major medical problems, or comorbidities that influenced UE usage or caused severe pain

Additionally, if patients have no metal implants, no head traumas or neurosurgical operations, and can perform MEG motor tasks, the participants can additionally participate in the MEG assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Action observation, imagery & execution	Behavioral: Action observation, imagery & execution; The participants will be asked to observe movements through a video clip, practice motor imagery, and executing the movements that the participants observed.
Active Comparator: Action observation	Behavioral: Action observation; The participants will be asked to observe videos and then practice what the participants observed.
Active Comparator: Control treatment	Behavioral: Control treatment; The participants will receive UE training without watching videos or imagining movements/tasks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change scores of Modified Rankin Scale	The Modified Rankin Scale is used to assess the degree of stroke disability.	baseline, 3 weeks , 3 months
Change scores of Fugl-Meyer Assessment	Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.	baseline, 3 weeks , 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change scores of Box and Block Test	The Box and Block Test is a measure of hand dexterity with satisfactory reliability and validity in patients with stroke.	baseline, 3 weeks , 3 months
Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)	The CAHAI measures the upper-limb motor function after stroke.	baseline, 3 weeks , 3 months
Change scores of Movement Imagery Questionnaire, revised second version	The MIQ-RS will be applied to assess patient's ability of motor imagery.	baseline, 3 weeks , 3 months
Change scores of Functional Independence Measure	The Functional Independence Measure is a frequently used scale to assess basic activities of daily function.	baseline, 3 weeks , 3 months
Change scores of physical intensity measured by activity monitors	The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The parameter of average intensity of physical activity (counts/minute) will be reported.	baseline, 3 weeks , 3 months
Change scores of energy expenditure measured by activity monitors	The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The parameter of energy expenditure(Kcal) will be reported.	baseline, 3 weeks , 3 months
Change scores of Stroke Impact Scale (SIS) Version 3.0	The Stroke Impact Scale Version 3.0 is a patient-reported outcome to evaluate function, participation, and health-related quality of life of stroke survivors with sound psychometric properties.	baseline, 3 weeks , 3 months
Magnetoencephalography (MEG)	Magnetoencephalography (MEG) can directly measure cortical neural activity and detect the oscillatory signals mainly by the changes in the postsynaptic fields of pyramidal cells. The MEG assessment will be conducted at baseline and immediately after treatment (3 weeks).	baseline, 3 weeks

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Yu-Wei Hsieh, PhD, Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, and Healthy Aging Research Center, Chang Gung University

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2017
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: stroke; MEG; neurorehabilitation; mirror neuron system; action observation; motor imagery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 201602056A3; N201705016 (Other Identifier: Taipei Medical University - JointInstitutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No