Action Observation, Imagery and Execution for Stroke Rehabilitation

Chang Gung Medical Foundation

Status

Completed

Conditions

Stroke

Treatments

Behavioral: Action observation, imagery & execution

Behavioral: Control treatment

Behavioral: Action observation

Study type

Interventional

Funder types

Other

Identifiers

NCT03246139

N201705016 (Other Identifier)

201602056A3

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No 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.