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Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke

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ClinicalTrials.gov Identifier: NCT02871700
Recruitment Status : Recruiting
First Posted : August 18, 2016
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:

The specific aims of this study will be to:

  1. investigate the treatment efficacy of Action observation therapy (AOT), mirror therapy (MT) versus a control intervention on motor and functional outcomes of stroke patients.
  2. compare the mechanisms and changes in cortical neural activity after AOT, MT, and control intervention by using magnetoencephalography (MEG).
  3. determine the correlations between neural activation changes and clinical outcomes after AOT and MT.
  4. identify who are the potential good responders to AOT and MT.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Action observation therapy Behavioral: Mirror therapy Behavioral: Customary bilateral UE training Not Applicable

Detailed Description:
In this 3-year study project, the investigators will design a comparative, randomized controlled trial to (1) investigate the treatment efficacy of AOT, MT versus a control intervention on motor and functional outcomes of stroke patients, (2) compare the mechanisms and changes in cortical neural activity after AOT, MT, and control intervention by using magnetoencephalography (MEG), (3) determine the correlations between neural activation changes and clinical outcomes after AOT and MT, and (4) identify who are the potential good responders to AOT and MT. An estimated total of 90 patients with subacute stroke will be recruited in this study. All participants will be randomly assigned to receive AOT, MT, or control intervention for a 3-week training period (a total of 15 sessions). Outcome measures will be conducted at baseline, immediately after treatment, and 3 months follow-up. For the MEG study, the investigators anticipate to recruit 12 to 15 patients in each group. The patients can still participate in this study to receive treatments and clinical evaluations even if they do not meet the MEG eligibility criteria or are not willing to participate in the MEG study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke: Rehabilitation Outcomes and Neural Mechanisms by MEG
Study Start Date : August 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: Action observation therapy (AOT)
Action observation therapy (AOT)
Behavioral: Action observation therapy
The patients were asked to observe everyday life actions of which they had motor experience or the actions belong to the motor repertoire of observers', they had better performance. The common categories of motor actions and tasks for stroke patients are selected in this study: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-extremity (UE) functional tasks practice.

Experimental: Mirror therapy (MT)
Mirror therapy (MT)
Behavioral: Mirror therapy
The MT group will receive 60 minutes of upper-limb training in a mirror box. MT treatment activities will include AROM exercises (10 to 15 minutes), reaching movement or object manipulation (15 to 20 minutes), and functional tasks practice (30 minutes) in a mirror box.

Active Comparator: Control group
Customary bilateral UE training
Behavioral: Customary bilateral UE training
The participants in this group will receive dose-matched customary bilateral UE training programs for 1 hour per session. The treatment protocol of control group will also include: (a) AROM exercises (10 to 15 minutes), (b) reaching movement or object manipulation (15 to 20 minutes), and (3) functional tasks practice (30 minutes).




Primary Outcome Measures :
  1. 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 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 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.

  3. Change scores of Wolf Motor Function Test [ Time Frame: baseline, 3 weeks , 3 months ]
    The Wolf Motor Function Test was initially developed to assess the effect of constraint-induced movement therapy. Through the timed score, function score and grip score to quantify upper extremity motor function in people with stroke.

  4. Change scores of Medical Research Council scale [ Time Frame: baseline, 3 weeks , 3 months ]
    The muscle power of the affected arm will be examined by the Medical Research Council scale.

  5. Change scores of Motor Activity Log [ Time Frame: baseline, 3 weeks , 3 months ]
    The Motor Activity Log consists of 30 structured questions to interview how the patients rate the frequency (amount of use subscale) and quality (quality of movement subscale) of movements while using their affected arm to accomplish 30 daily activities.

  6. Change scores of Chedoke Arm and Hand Activity Inventory [ Time Frame: baseline, 3 weeks , 3 months ]
    The Chedoke Arm and Hand Activity Inventory is a new measurement development for assessing upper extremity function after stroke.

  7. Change scores of Revised Nottingham Sensory Assessment [ Time Frame: baseline, 3 weeks , 3 months ]
    The Revised Nottingham Sensory Assessment includes the assessment of tactile sensation, kinesthetic sensation, and stereognosis and is a reliable measure of sensory function in stroke patients.

  8. 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 UE.

  9. Change scores of Questionnaire Upon Mental Imagery [ Time Frame: baseline, 3 weeks , 3 months ]
    The short-form of Questionnaire Upon Mental Imagery is applied to assess patient's ability of mental imagery.

  10. 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.

  11. Change scores of Stroke Impact Scale 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.

  12. Change scores of ActiGraph [ Time Frame: baseline, 3 weeks ]
    The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The main outcome parameters will be the average intensity of physical activity (counts/minute), types of activity, and energy expenditure(Kcal) in real life.

  13. Magnetoencephalography [ Time Frame: baseline, 3 weeks ]
    Magnetoencephalography can directly measure cortical neural activity and detect the oscillatory signals mainly by the changes in the postsynaptic fields of pyramidal cells

  14. Change scores of Visual Analogue Scale for pain [ Time Frame: baseline, 3 weeks ]
    Patient-reported pain on the Visual Analogue Scale

  15. Change scores of Visual Analogue Scale for fatigue [ Time Frame: baseline, 3 weeks ]
    Patient-reported fatigue on the Visual Analogue Scale



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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:

  1. diagnosed as having a unilateral stroke
  2. 1 to 6 months after stroke onset
  3. from 20 to 80 years of age
  4. a baseline score of the Fugl-Meyer Assessment (FMA) of 20 to 60
  5. able to follow the study instructions (measured by the Montreal Cognitive Assessment)
  6. capable of participating in therapy and assessment sessions

Exclusion Criteria:

  1. patients with global or receptive aphasia
  2. severe neglect
  3. major medical problems, or comorbidities that influenced UE usage or caused severe pain

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): NCT02871700


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

Locations
Taiwan
Taipei Tzu Chi hospital, Buddhist Tzu Chi Medical fundation Recruiting
Taipei, Taiwan, 231
Contact: Yu-Wei Hsieh, PhD    +886-3-2118800 ext 3820    ywhsieh@mail.cgu.edu.tw   
Cathay General Hospital (Taipei and Sijhi) Recruiting
Taipei, Taiwan
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, Taiwan, 33351
Contact: Yu-Wei Hsieh, PhD    +886-3-2118800 ext 3820    ywhsieh@mail.cgu.edu.tw   
Taoyuan Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Yu-Wei Hsieh, PhD    +886-3-2118800 ext 3820    ywhsieh@mail.cgu.edu.tw   
Contact: Chih-Chi Chen, MD    +886-3-3281200 ext 3846    m7041@adm.cgmh.org.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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02871700     History of Changes
Other Study ID Numbers: 104-9173A3
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chang Gung Memorial Hospital:
stroke
translational rehabilitation
mirror neuron system
action observation
mirror therapy
MEG

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