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

Stroke Clinical Trial

Official title:

Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke: Rehabilitation Outcomes and Neural Mechanisms by MEG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871700
• Other study ID #: 104-9173A3
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: October 2017

Study information

• Verified date: January 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.
• 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).

Locations

Country	Name	City	State
Taiwan	Cathay General Hospital (Taipei and Sijhi)	Taipei
Taiwan	Taipei Tzu Chi hospital, Buddhist Tzu Chi Medical fundation	Taipei
Taiwan	Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare	Taoyuan
Taiwan	Taoyuan Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change scores of Fugl-Meyer Assessment	Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.	baseline, 3 weeks , 3 months
Secondary	Change scores of Modified Rankin Scale	The Modified Rankin Scale is used to assess the degree of stroke disability.	baseline, 3 weeks , 3 months
Secondary	Change scores of Box and Block Test	The Box and Block Test is a measure of hand dexterity with satisfactory reliability and validity in patients with stroke.	baseline, 3 weeks , 3 months
Secondary	Change scores of Wolf Motor Function Test	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.	baseline, 3 weeks , 3 months
Secondary	Change scores of Medical Research Council scale	The muscle power of the affected arm will be examined by the Medical Research Council scale.	baseline, 3 weeks , 3 months
Secondary	Change scores of Motor Activity Log	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.	baseline, 3 weeks , 3 months
Secondary	Change scores of Chedoke Arm and Hand Activity Inventory	The Chedoke Arm and Hand Activity Inventory is a new measurement development for assessing upper extremity function after stroke.	baseline, 3 weeks , 3 months
Secondary	Change scores of Revised Nottingham Sensory Assessment	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.	baseline, 3 weeks , 3 months
Secondary	Change scores of ABILHAND questionnaire	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.	baseline, 3 weeks , 3 months
Secondary	Change scores of Questionnaire Upon Mental Imagery	The short-form of Questionnaire Upon Mental Imagery is applied to assess patient's ability of mental imagery.	baseline, 3 weeks , 3 months
Secondary	Change scores of Functional Independence Measure	The Functional Independence Measure is a frequently used scale to assess basic activities of daily function.	baseline, 3 weeks , 3 months
Secondary	Change scores of Stroke Impact Scale Version 3.0	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.	baseline, 3 weeks , 3 months
Secondary	Change scores of ActiGraph	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.	baseline, 3 weeks
Secondary	Magnetoencephalography	Magnetoencephalography can directly measure cortical neural activity and detect the oscillatory signals mainly by the changes in the postsynaptic fields of pyramidal cells	baseline, 3 weeks
Secondary	Change scores of Visual Analogue Scale for pain	Patient-reported pain on the Visual Analogue Scale	baseline, 3 weeks
Secondary	Change scores of Visual Analogue Scale for fatigue	Patient-reported fatigue on the Visual Analogue Scale	baseline, 3 weeks