Clinical trial NCT02871700: Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke
Official title: Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke: Rehabilitation Outcomes and Neural Mechanisms by MEG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
translational rehabilitation
mirror neuron system
action observation
mirror therapy
MEG
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The specific aims of this study will be to:

1. investigate the treatment efficacy of Action observation therapy (AOT), mirror therapy (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.
4. 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.

Eligibility criteria: Inclusion Criteria:

1. diagnosed as having a unilateral stroke
2. 1 to 6 months after stroke onset
3. from 20 to 80 years of age
4. a baseline score of the Fugl-Meyer Assessment (FMA) of 20 to 60
5. able to follow the study instructions (measured by the Montreal Cognitive Assessment)
6. capable of participating in therapy and assessment sessions

Exclusion Criteria:

1. patients with global or receptive aphasia
2. severe neglect
3. major medical problems, or comorbidities that influenced UE usage or caused severe pain

Primary outcomes:
measure: Change scores of Fugl-Meyer Assessment
timeFrame: baseline, 3 weeks , 3 months
Secondary outcomes:
measure: Change scores of Modified Rankin Scale
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of Box and Block Test
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of Wolf Motor Function Test
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of Medical Research Council scale
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of Motor Activity Log
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of Chedoke Arm and Hand Activity Inventory
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of Revised Nottingham Sensory Assessment
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of ABILHAND questionnaire
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of Questionnaire Upon Mental Imagery
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of Functional Independence Measure
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of Stroke Impact Scale Version 3.0
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of ActiGraph
timeFrame: baseline, 3 weeks
measure: Magnetoencephalography
timeFrame: baseline, 3 weeks
measure: Change scores of Visual Analogue Scale for pain
timeFrame: baseline, 3 weeks
measure: Change scores of Visual Analogue Scale for fatigue
timeFrame: baseline, 3 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Tzu Chi hospital, Buddhist Tzu Chi Medical fundation
city: Taipei
country: Taiwan
facility: Cathay General Hospital (Taipei and Sijhi)
city: Taoyuan
country: Taiwan
facility: Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare
city: Taoyuan
country: Taiwan
facility: Taoyuan Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, and Healthy Aging Research Center, Chang Gung University
name: Yu-Wei Hsieh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsieh YW, Lin YH, Zhu JD, Wu CY, Lin YP, Chen CC. Treatment Effects of Upper Limb Action Observation Therapy and Mirror Therapy on Rehabilitation Outcomes after Subacute Stroke: A Pilot Study. Behav Neurol. 2020 Jan 2;2020:6250524. doi: 10.1155/2020/6250524. eCollection 2020.
citation: Shih TY, Wu CY, Lin KC, Cheng CH, Hsieh YW, Chen CL, Lai CJ, Chen CC. Effects of action observation therapy and mirror therapy after stroke on rehabilitation outcomes and neural mechanisms by MEG: study protocol for a randomized controlled trial. Trials. 2017 Oct 4;18(1):459. doi: 10.1186/s13063-017-2205-z.