Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke: Rehabilitation Outcomes and Neural Mechanisms by MEG
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 21
- Locations
- 4
- Primary Endpoint
- Change scores of Fugl-Meyer Assessment
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The specific aims of this study will be to:
- investigate the treatment efficacy of Action observation therapy (AOT), mirror therapy (MT) versus a control intervention on motor and functional outcomes of stroke patients.
- compare the mechanisms and changes in cortical neural activity after AOT, MT, and control intervention by using magnetoencephalography (MEG).
- determine the correlations between neural activation changes and clinical outcomes after AOT and MT.
- identify who are the potential good responders to AOT and MT.
Detailed Description
In this 3-year study project, the investigators will design a comparative, randomized controlled trial to (1) investigate the treatment efficacy of AOT, MT versus a control intervention on motor and functional outcomes of stroke patients, (2) compare the mechanisms and changes in cortical neural activity after AOT, MT, and control intervention by using magnetoencephalography (MEG), (3) determine the correlations between neural activation changes and clinical outcomes after AOT and MT, and (4) identify who are the potential good responders to AOT and MT. An estimated total of 90 patients with subacute stroke will be recruited in this study. All participants will be randomly assigned to receive AOT, MT, or control intervention for a 3-week training period (a total of 15 sessions). Outcome measures will be conducted at baseline, immediately after treatment, and 3 months follow-up. For the MEG study, the investigators anticipate to recruit 12 to 15 patients in each group. The patients can still participate in this study to receive treatments and clinical evaluations even if they do not meet the MEG eligibility criteria or are not willing to participate in the MEG study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •diagnosed as having a unilateral stroke
- •1 to 6 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 (measured by the Montreal Cognitive Assessment)
- •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
Outcomes
Primary Outcomes
Change scores of Fugl-Meyer Assessment
Time Frame: baseline, 3 weeks , 3 months
Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.
Secondary Outcomes
- Change scores of Modified Rankin Scale(baseline, 3 weeks , 3 months)
- Change scores of Box and Block Test(baseline, 3 weeks , 3 months)
- Change scores of Chedoke Arm and Hand Activity Inventory(baseline, 3 weeks , 3 months)
- Change scores of Wolf Motor Function Test(baseline, 3 weeks , 3 months)
- Change scores of Medical Research Council scale(baseline, 3 weeks , 3 months)
- Change scores of Motor Activity Log(baseline, 3 weeks , 3 months)
- Change scores of Revised Nottingham Sensory Assessment(baseline, 3 weeks , 3 months)
- Change scores of ABILHAND questionnaire(baseline, 3 weeks , 3 months)
- Change scores of Questionnaire Upon Mental Imagery(baseline, 3 weeks , 3 months)
- Change scores of Functional Independence Measure(baseline, 3 weeks , 3 months)
- Change scores of Stroke Impact Scale Version 3.0(baseline, 3 weeks , 3 months)
- Change scores of ActiGraph(baseline, 3 weeks)
- Magnetoencephalography(baseline, 3 weeks)
- Change scores of Visual Analogue Scale for pain(baseline, 3 weeks)
- Change scores of Visual Analogue Scale for fatigue(baseline, 3 weeks)