Action Observation, Imagery and Execution for Stroke Rehabilitation

NCT ID: NCT03246139

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-23
• Study Completion Date: 2020-07-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Action observation, imagery & execution

Group Type: EXPERIMENTAL

Action observation, imagery & execution

Intervention Type: BEHAVIORAL

The participants will be asked to observe movements through a video clip, practice motor imagery, and executing the movements that the participants observed.

Action observation

Group Type: ACTIVE_COMPARATOR

Action observation

Intervention Type: BEHAVIORAL

The participants will be asked to observe videos and then practice what the participants observed.

Control treatment

Group Type: ACTIVE_COMPARATOR

Control treatment

Intervention Type: BEHAVIORAL

The participants will receive UE training without watching videos or imagining movements/tasks.

Interventions

Action observation, imagery & execution

The participants will be asked to observe movements through a video clip, practice motor imagery, and executing the movements that the participants observed.

Intervention Type: BEHAVIORAL

Action observation

The participants will be asked to observe videos and then practice what the participants observed.

Intervention Type: BEHAVIORAL

Control treatment

The participants will receive UE training without watching videos or imagining movements/tasks.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Wei Hsieh, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, and Healthy Aging Research Center, Chang Gung University

Locations

Taipei medical university hospital

Taipei, , Taiwan

Taipei Medical University Shuang Ho Hospital

Taipei, , Taiwan

Taoyuan Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare

Taoyuan, , Taiwan

Countries

Taiwan

Other Identifiers

N201705016

Identifier Type: OTHER

Identifier Source: secondary_id

201602056A3

Identifier Type: -

Identifier Source: org_study_id