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Action Observation, Imagery and Execution for Stroke Rehabilitation

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Action observation, imagery & execution
Action observation
Control treatment
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, neurorehabilitation, mirror neuron system, action observation, motor imagery, MEG

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taipei medical university hospital
  • Taipei Medical University Shuang Ho Hospital
  • Taoyuan Chang Gung Memorial Hospital
  • Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Action observation, imagery & execution

Action observation

Control treatment

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)
The CAHAI measures the upper-limb motor function after stroke.
Change scores of Movement Imagery Questionnaire, revised second version
The MIQ-RS will be applied to assess patient's ability of motor imagery.
Change scores of Functional Independence Measure
The Functional Independence Measure is a frequently used scale to assess basic activities of daily function.
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.
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.
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.
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).

Full Information

First Posted
August 3, 2017
Last Updated
January 25, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03246139
Brief Title
Action Observation, Imagery and Execution for Stroke Rehabilitation
Official Title
Action Observation, Imagery and Execution as a New Intervention Strategy for Stroke Rehabilitation: Short- and Long-term Treatment Effects and Neural Mechanism
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 23, 2017 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The specific study aims will be: 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. To examine the neural mechanisms and changes in cortical neural activity after the interventions in stroke patients. To examine the correlations between AOIE-induced brain activation changes and the clinical efficacy of AOIE. To identify who are the possible good responders to the therapy based on baseline motor function and motor imagery ability of the participants.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, neurorehabilitation, mirror neuron system, action observation, motor imagery, MEG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Action observation, imagery & execution
Arm Type
Experimental
Arm Title
Action observation
Arm Type
Active Comparator
Arm Title
Control treatment
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Action observation, imagery & execution
Intervention Description
The participants will be asked to observe movements through a video clip, practice motor imagery, and executing the movements that the participants observed.
Intervention Type
Behavioral
Intervention Name(s)
Action observation
Intervention Description
The participants will be asked to observe videos and then practice what the participants observed.
Intervention Type
Behavioral
Intervention Name(s)
Control treatment
Intervention Description
The participants will receive UE training without watching videos or imagining movements/tasks.
Primary Outcome Measure Information:
Title
Change scores of Modified Rankin Scale
Description
The Modified Rankin Scale is used to assess the degree of stroke disability.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of Fugl-Meyer Assessment
Description
Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.
Time Frame
baseline, 3 weeks , 3 months
Secondary Outcome Measure Information:
Title
Change scores of Box and Block Test
Description
The Box and Block Test is a measure of hand dexterity with satisfactory reliability and validity in patients with stroke.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)
Description
The CAHAI measures the upper-limb motor function after stroke.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of Movement Imagery Questionnaire, revised second version
Description
The MIQ-RS will be applied to assess patient's ability of motor imagery.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of Functional Independence Measure
Description
The Functional Independence Measure is a frequently used scale to assess basic activities of daily function.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of physical intensity measured by activity monitors
Description
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.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of energy expenditure measured by activity monitors
Description
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.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of Stroke Impact Scale (SIS) Version 3.0
Description
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.
Time Frame
baseline, 3 weeks , 3 months
Title
Magnetoencephalography (MEG)
Description
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).
Time Frame
baseline, 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Wei Hsieh, PhD
Organizational Affiliation
Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, and Healthy Aging Research Center, Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei medical university hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Taipei Medical University Shuang Ho Hospital
City
Taipei
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
Taoyuan Chang Gung Memorial Hospital
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare
City
Taoyuan City
ZIP/Postal Code
3351
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Action Observation, Imagery and Execution for Stroke Rehabilitation

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