Clinical trial NCT04978311: Mirror Feedback, Augmented Task-Specific, Impairment-Oriented Therapy, Home Practice, Stroke Rehabilitation
Official title: The Effects of Mirror Feedback Augmented Task-Specific and Impairment-Oriented Therapy With Home Practice in Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Rehabilitation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators will (1) examine immediate and long-term effects of MT priming with task-specific training versus MT-priming with impairment-oriented training, relative to a dose-matched control therapy on motor function, arm activities, quality of life, etc; (2) provide comprehensive evaluations based on the ICF model to identify the specific benefits of MT-priming regimens; and (3) explore demographic and clinical characteristics of participants that may predict treatment outcomes.

Detailed description: Stroke is one of the major causes of long-term disability. Most stroke survivors suffer from arm paresis even in the chronic phase. There is a need to develop novel strategies to augment therapeutic efficacy in stroke rehabilitation. One potential method to enhance treatment efficacy is through the "priming" technique. Among all priming techniques, mirror therapy (MT) has been proposed to be a promising method to augment effects of motor re-training. The investigators propose a 3-year research project to determine the effects of MT-priming on augmenting stroke interventions. The investigators select two types of evidence-based neurorehabilitation, the task-specific training and the impairment-oriented training, to be primed by MT based on their unique treatment benefits on restoring arm ability. In addition, the investigators will provide customized home practice corresponding to each type of interventions. Specifically, the investigators will (1) examine immediate and long-term effects of MT priming with task-specific training versus MT-priming with impairment-oriented training, relative to a dose-matched control therapy on motor function, arm activities, quality of life, etc; (2) provide comprehensive evaluations based on the ICF model to identify the specific benefits of MT-priming regimens; and (3) explore demographic and clinical characteristics of participants that may predict treatment outcomes.

Eligibility criteria: Inclusion criteria:

* A first ever-stroke≧3 months
* Baseline Fugl-Meyer assessment of upper extremity scale (FMA-UE) between 18 to 56 (Fugl-Meyer et al. 1975)
* No excessive muscle spasticity of the affected arm (Modified Ashworth Scale \< 3 at any joints of the affected arm) (Bohannon \& Smith 1987)
* Able to follow examiners' commands and study instructions (Mini-Mental State Examination score≧22) (Folstein et al. 1975)
* No participation in any other experimental rehabilitation or drug studies during period of this project

Exclusion criteria:

* Concomitant neurologic, neuromuscular or orthopedic conditions that may interfere with participation of this project
* Epilepsy within three months

Primary outcomes:
measure: Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks, and 18 weeks
timeFrame: Baseline, 6 weeks, and 18 weeks
measure: Change from Baseline Motor Activity Log (MAL) at 6 weeks, and 18 weeks
timeFrame: Baseline, 6 weeks and 18 weeks
Secondary outcomes:
measure: Change from Baseline Nottingham Extended Activities of Daily Living Scale (NEADL) at 6 weeks, and 18 weeks
timeFrame: Baseline, 6 weeks and 18 weeks
measure: Change from Baseline Stroke Impact Scale Version 3.0 (SIS 3.0) at 6 weeks, and 18 weeks
timeFrame: Baseline, 6 weeks, and 18 weeks
measure: Change from Baseline Wolf Motor Function Test (WMFT) score at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Grip and Pinch strength at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Chedoke Arm and Hand Activity Inventory (CAHAI) at 6 weeks
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Feng Yuan Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hosipital
Study officials:
affiliation: School of Occupational Therapy, National Taiwan University, Taipei, Taiwan
name: Keh-chung Lin, ScD
role: PRINCIPAL_INVESTIGATOR
References: