Clinical trial NCT01656876: The Effects of Mirror Therapy on Upper Extremity in Stroke Patients
Official title: The Effects of Mirror Therapy on Upper Extremity in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Comparative effectiveness research
Mirror therapy
Stroke rehabilitation
Clinical evaluation
Kinematic analysis
Mesh glove
Combined therapy
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2012-08-03
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare treatment efficacy of mirror therapy (MT), mirror therapy combining mesh glove (MG+MT) stimulation, and controlled treatment (CT) in people with stroke.

Detailed description: 55% to 75% of people after stroke have a paretic arm that causes motor impairment. Among novel rehabilitation interventions, MT was found to be beneficial and comparatively low-cost. MT reduced motor impairment possibly in part of recruiting the premotor cortex or balancing the neural activation within the primary motor cortex toward the affected hemisphere. However, the benefits in certain aspects of outcomes are under debate. Another treatment, MG, can be used to normalize muscle tone, suppress muscle spasticity, enhance residual volitional activity of hand and arm, or even increasing walking speed. In addition, providing MG stimulation might result in plastic changes in the primary motor cortex, and induced a long-lasting modulated effect on motor cortical excitability. The possible mechanism of brain plasticity underlying MG is collective with the mechanism behind the MT. Adding MG to MT might augment the cortical reorganization. In sum, combining MT with MG may supplement the disadvantage or uncertain effects of MT and broaden the benefited outcomes.

Eligibility criteria: Inclusion Criteria:

* The onset duration more than 3 months
* Demonstration of Brunnstrom stage equal to or above stage III of the affected upper extremity
* No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
* No serious visual and visual-perception impairments
* No concurrent participation in other drug or rehabilitation research
* No serious attention deficits
* No excessive spasticity in any of the joints of the affected UL exclusion criteria

Exclusion Criteria:

* Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation
* Excessive pain in any joint that might limit participation

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: Baseline, change from baseline in FMA at 4 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
measure: Wolf Motor Function Test (WMFT)
timeFrame: Baseline, change from baseline in WMFT at 4 weeks, change from baseline in WMFT at 16 weeks, change from baseline in WMFT at 28 weeks
measure: Accelerometers
timeFrame: Baseline, change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
measure: revised Nottingham Sensory Assessment (rNSA)
timeFrame: Baseline, change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
Secondary outcomes:
measure: Kinematic analyses
timeFrame: Baseline, change from baseline in kinematic parameters at 4 weeks
measure: Motor Activity Log (MAL)
timeFrame: Baseline, change from baseline in MAL at 4 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
measure: Semmes-Weinstein monofilaments
timeFrame: Baseline, change from baseline in Semmes-Weistein monofilaments at 4 weeks, change from baseline in Semmes-Weistein monofilaments at 16 weeks, change from baseline in Semmes-Weistein monofilaments at 28 weeks
measure: Functional Independence Measure (FIM)
timeFrame: Baseline, change from baseline in FIM at 4 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
measure: Stroke Impact Scale version 3.0 (SIS 3.0)
timeFrame: Baseline, change from baseline in SIS at 4 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
measure: 8-OHdG
timeFrame: Baseline, change from baseline in 8-OHDG at 4 weeks, change from baseline in 8-OHDG at 16 weeks, change from baseline in 8-OHDG at 28 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Shuang-Ho Hospital, Taipei Medical University
Study officials:
affiliation: Shuang-Ho Hospital, Taipei Medical University
name: Tsan-hon Liou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Occupational Therapy, College of Medicine, Chang Gung University
name: Ching-yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Occupational Therapy, College of Medicine, National Taiwan University
name: Keh-chung Lin, ScD
role: PRINCIPAL_INVESTIGATOR
References: