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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: Customary bilateral UE training; Behavioral: Mirror therapy; Behavioral: Action observation therapy

• Registration Number: NCT02871700
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-18
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Customary bilateral UE training	Customary bilateral UE training
Mirror therapy (MT)	Mirror therapy	Mirror therapy (MT)
Action observation therapy (AOT)	Action observation therapy	Action observation therapy (AOT)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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	baseline, 3 weeks , 3 months	The Chedoke Arm and Hand Activity Inventory is a new measurement development for assessing upper extremity function after stroke.
Change scores of Wolf Motor Function Test	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.
Change scores of Medical Research Council scale	baseline, 3 weeks , 3 months	The muscle power of the affected arm will be examined by the Medical Research Council scale.
Change scores of Motor Activity Log	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.
Change scores of Revised Nottingham Sensory Assessment	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.
Change scores of ABILHAND questionnaire	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.
Change scores of Questionnaire Upon Mental Imagery	baseline, 3 weeks , 3 months	The short-form of Questionnaire Upon Mental Imagery is applied to assess patient's ability of mental 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 Stroke Impact Scale 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.
Change scores of ActiGraph	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.
Magnetoencephalography	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
Change scores of Visual Analogue Scale for pain	baseline, 3 weeks	Patient-reported pain on the Visual Analogue Scale
Change scores of Visual Analogue Scale for fatigue	baseline, 3 weeks	Patient-reported fatigue on the Visual Analogue Scale

Trial Locations

Locations (4)

Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare; 🇨🇳 Taoyuan, Taiwan

Cathay General Hospital (Taipei and Sijhi); 🇨🇳 Taipei, Taiwan

Taipei Tzu Chi hospital, Buddhist Tzu Chi Medical fundation; 🇨🇳 Taipei, Taiwan

Taoyuan Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan