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Action Observation, Imagery and Execution for Stroke Rehabilitation

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ClinicalTrials.gov Identifier: NCT03246139
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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 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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Action observation, imagery & execution Behavioral: Action observation Behavioral: Customary upper-extremity rehabilitation Not Applicable

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 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 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 : August 1, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


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: Customary upper-extremity rehabilitation Behavioral: Customary upper-extremity rehabilitation
The participants will receive UE training without watching videos or imagining movements/tasks.




Primary Outcome Measures :
  1. Change scores of Modified Rankin Scale [ Time Frame: baseline, 3 weeks , 3 months ]
    The Modified Rankin Scale is used to assess the degree of stroke disability.

  2. Change scores of Fugl-Meyer Assessment [ Time Frame: baseline, 3 weeks , 3 months ]
    Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.


Secondary Outcome Measures :
  1. Change scores of Box and Block Test [ Time Frame: 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.

  2. Change scores of ABILHAND questionnaire [ Time Frame: baseline, 3 weeks , 3 months ]
    The ABILHAND Questionnaire is a self-reported and Rasch-based scale that assesses patients' perceived difficulty in performing daily activities that require the use of the bilateral.

  3. Change scores of Movement Imagery Questionnaire, revised second version [ Time Frame: baseline, 3 weeks , 3 months ]
    The MIQ-RS will be applied to assess patient's ability of motor imagery.

  4. Change scores of Functional Independence Measure [ Time Frame: baseline, 3 weeks , 3 months ]
    The Functional Independence Measure is a frequently used scale to assess basic activities of daily function.

  5. Change scores of physical intensity measured by activity monitors [ Time Frame: 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.

  6. Change scores of energy expenditure measured by activity monitors [ Time Frame: 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.

  7. Change scores of Stroke Impact Scale (SIS) Version 3.0 [ Time Frame: 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.

  8. Magnetoencephalography (MEG) [ Time Frame: 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).



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246139


Contacts
Contact: Yu-Wei Hsieh, PhD 886-3-2118800 ext 3820 ywhsieh@mail.cgu.edu.tw

Locations
Taiwan
Taipei medical university hospital Recruiting
Taipei, Taiwan, 110
Contact: Yu-Wei Hsieh, PhD    +886-3-2118800 ext 3820    ywhsieh@mail.cgu.edu.tw   
Taipei Medical University Shuang Ho Hospital Recruiting
Taipei, Taiwan, 23561
Contact: Yu-wei Hsieh, PhD    +886-3-2118800 ext 3820    ywhsieh@mail.cgu.edu.tw   
Taoyuan Chang Gung Memorial Hospital Recruiting
Taoyuan City, Taiwan, 333
Contact: Yu-Wei Hsieh, PhD    +886-3-2118800 ext 3820    ywhsieh@mail.cgu.edu.tw   
Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare Recruiting
Taoyuan City, Taiwan, 3351
Contact: Yu-Wei Hsieh, PhD    +886-3-2118800 ext 3820    ywhsieh@mail.cgu.edu.tw   
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

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03246139     History of Changes
Other Study ID Numbers: 201602056A3
N201705016 ( Other Identifier: Taipei Medical University - JointInstitutional Review Board )
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chang Gung Memorial Hospital:
stroke
neurorehabilitation
mirror neuron system
action observation
motor imagery
MEG

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases