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NCT number NCT03246139
Study type Interventional
Source Chang Gung Memorial Hospital
Contact Yu-Wei Hsieh, PhD
Phone 886-3-2118800
Status Recruiting
Phase N/A
Start date August 1, 2017
Completion date July 31, 2020

Clinical Trial 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 customary rehabilitation 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.

Clinical Trial 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 customary rehabilitation 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 Design

Related Conditions & MeSH terms

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