Action Observation, Imagery and Execution for Stroke Rehabilitation

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03246139

Collaborator

(none)

Enrollment

Locations

Arms

35.3

Actual Duration (Months)

4.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: Action observation, imagery & execution Behavioral: Action observation Behavioral: Control treatment	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Action Observation, Imagery and Execution as a New Intervention Strategy for Stroke Rehabilitation: Short- and Long-term Treatment Effects and Neural Mechanism

Actual Study Start Date :

Aug 23, 2017

Actual Primary Completion Date :

Jul 31, 2020

Actual Study Completion Date :

Jul 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Action observation, imagery & execution	Behavioral: 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.
Active Comparator: Action observation	Behavioral: Action observation The participants will be asked to observe videos and then practice what the participants observed.
Active Comparator: Control treatment	Behavioral: Control treatment The participants will receive UE training without watching videos or imagining movements/tasks.

Arm

Intervention/Treatment

Experimental: Action observation, imagery & execution

Behavioral: 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.

Active Comparator: Action observation

Behavioral: Action observation

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

Active Comparator: Control treatment

Behavioral: Control treatment

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

Outcome Measures

Primary Outcome Measures

Change scores of Modified Rankin Scale [baseline, 3 weeks , 3 months]
The Modified Rankin Scale is used to assess the degree of stroke disability.
Change scores of Fugl-Meyer Assessment [baseline, 3 weeks , 3 months]
Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.

Secondary Outcome Measures

Change scores of Box and Block Test [baseline, 3 weeks , 3 months]
The Box and Block Test is a measure of hand dexterity with satisfactory reliability and validity in patients with stroke.
Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI) [baseline, 3 weeks , 3 months]
The CAHAI measures the upper-limb motor function after stroke.
Change scores of Movement Imagery Questionnaire, revised second version [baseline, 3 weeks , 3 months]
The MIQ-RS will be applied to assess patient's ability of motor imagery.
Change scores of Functional Independence Measure [baseline, 3 weeks , 3 months]
The Functional Independence Measure is a frequently used scale to assess basic activities of daily function.
Change scores of physical intensity measured by activity monitors [baseline, 3 weeks , 3 months]
The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The parameter of average intensity of physical activity (counts/minute) will be reported.
Change scores of energy expenditure measured by activity monitors [baseline, 3 weeks , 3 months]
The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The parameter of energy expenditure(Kcal) will be reported.
Change scores of Stroke Impact Scale (SIS) Version 3.0 [baseline, 3 weeks , 3 months]
The Stroke Impact Scale Version 3.0 is a patient-reported outcome to evaluate function, participation, and health-related quality of life of stroke survivors with sound psychometric properties.
Magnetoencephalography (MEG) [baseline, 3 weeks]
Magnetoencephalography (MEG) can directly measure cortical neural activity and detect the oscillatory signals mainly by the changes in the postsynaptic fields of pyramidal cells. The MEG assessment will be conducted at baseline and immediately after treatment (3 weeks).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Taipei medical university hospital	Taipei	Taiwan	110
2	Taipei Medical University Shuang Ho Hospital	Taipei	Taiwan	23561
3	Taoyuan Chang Gung Memorial Hospital	Taoyuan City	Taiwan	333
4	Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare	Taoyuan City	Taiwan	3351

Sponsors and Collaborators

Chang Gung Memorial Hospital

Investigators

Principal Investigator: Yu-Wei Hsieh, PhD, Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, and Healthy Aging Research Center, Chang Gung University