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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02871700
• Date of registration: 01/08/2016
• Prospective Registration: Yes
• Primary sponsor: Chang Gung Memorial Hospital
• Public title: Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke
• Scientific title: Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke: Rehabilitation Outcomes and Neural Mechanisms by MEG
• Date of first enrolment: August 2016
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02871700
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Taiwan

Contacts

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

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

Behavioral: Action observation therapy

Behavioral: Mirror therapy

Behavioral: Customary bilateral UE training

Primary Outcome(s)

Change scores of Fugl-Meyer Assessment [Time Frame: baseline, 3 weeks , 3 months]

Secondary Outcome(s)

Change scores of ActiGraph [Time Frame: baseline, 3 weeks]

Change scores of Modified Rankin Scale [Time Frame: baseline, 3 weeks , 3 months]

Change scores of Visual Analogue Scale for pain [Time Frame: baseline, 3 weeks]

Change scores of Box and Block Test [Time Frame: baseline, 3 weeks , 3 months]

Change scores of Medical Research Council scale [Time Frame: baseline, 3 weeks , 3 months]

Change scores of Stroke Impact Scale Version 3.0 [Time Frame: baseline, 3 weeks , 3 months]

Change scores of Visual Analogue Scale for fatigue [Time Frame: baseline, 3 weeks]

Change scores of Motor Activity Log [Time Frame: baseline, 3 weeks , 3 months]

Change scores of Questionnaire Upon Mental Imagery [Time Frame: baseline, 3 weeks , 3 months]

Change scores of Wolf Motor Function Test [Time Frame: baseline, 3 weeks , 3 months]

Change scores of ABILHAND questionnaire [Time Frame: baseline, 3 weeks , 3 months]

Change scores of Chedoke Arm and Hand Activity Inventory [Time Frame: baseline, 3 weeks , 3 months]

Change scores of Functional Independence Measure [Time Frame: baseline, 3 weeks , 3 months]

Magnetoencephalography [Time Frame: baseline, 3 weeks]

Change scores of Revised Nottingham Sensory Assessment [Time Frame: baseline, 3 weeks , 3 months]

Secondary ID(s)

104-9173A3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors