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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Mirror therapy Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Mirror therapy (MT)
    Description: Mirror therapy (MT)
  • Action observation therapy Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Action observation therapy (AOT)
    Description: Action observation therapy (AOT)
  • Customary bilateral UE training Behavioral
    Intervention Desc: 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).
    ARM 1: Kind: Experimental
    Label: Control group
    Description: Customary bilateral UE training

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change scores of Fugl-Meyer Assessment baseline, 3 weeks , 3 months No
Secondary Change scores of Modified Rankin Scale baseline, 3 weeks , 3 months No
Secondary Change scores of Box and Block Test baseline, 3 weeks , 3 months No
Secondary Change scores of ABILHAND questionnaire baseline, 3 weeks , 3 months No
Secondary Change scores of Questionnaire Upon Mental Imagery baseline, 3 weeks , 3 months No
Secondary Change scores of Functional Independence Measure baseline, 3 weeks , 3 months No
Secondary Change scores of Stroke Impact Scale Version 3.0 baseline, 3 weeks , 3 months No
Secondary Change scores of ActiGraph baseline, 3 weeks No
Secondary Magnetoencephalography baseline, 3 weeks No
Secondary Change scores of Visual Analogue Scale for pain baseline, 3 weeks Yes
Secondary Change scores of Visual Analogue Scale for fatigue baseline, 3 weeks Yes
Secondary Change scores of Wolf Motor Function Test baseline, 3 weeks , 3 months No
Secondary Change scores of Medical Research Council scale baseline, 3 weeks , 3 months No
Secondary Change scores of Motor Activity Log baseline, 3 weeks , 3 months No
Secondary Change scores of Chedoke Arm and Hand Activity Inventory baseline, 3 weeks , 3 months No
Secondary Change scores of Revised Nottingham Sensory Assessment baseline, 3 weeks , 3 months No

Sponsors