Clinical trial NCT03246139: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
neurorehabilitation
mirror neuron system
action observation
motor imagery
MEG
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 17
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 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.

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.

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.

Primary outcomes:
measure: Change scores of Modified Rankin Scale
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of Fugl-Meyer Assessment
timeFrame: baseline, 3 weeks , 3 months
Secondary outcomes:
measure: Change scores of Box and Block Test
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of Movement Imagery Questionnaire, revised second version
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of Functional Independence Measure
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of physical intensity measured by activity monitors
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of energy expenditure measured by activity monitors
timeFrame: baseline, 3 weeks , 3 months
measure: Change scores of Stroke Impact Scale (SIS) Version 3.0
timeFrame: baseline, 3 weeks , 3 months
measure: Magnetoencephalography (MEG)
timeFrame: baseline, 3 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei medical university hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taoyuan City
country: Taiwan
facility: Taoyuan Chang Gung Memorial Hospital
city: Taoyuan City
country: Taiwan
facility: Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare
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: