Clinical trial NCT02548234: Effect of Mirror Therapy Versus Bilateral Arm Training for Rehabilitation After Chronic Stroke
Official title: Effect of Mirror Therapy Versus Bilateral Arm Training for Rehabilitation After Chronic Stroke: a Pilot Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Randomized control trial
Mirror therapy
Bilateral arm training
Comparative efficacy research
Neurorehabilitation
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 29
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study purpose is to compare the efficacy of mirror therapy and bilateral arm training on movement strategies of the affected upper extremity and functional outcome in chronic stroke patients.

Detailed description: Study background: Approximately 80% of stroke survivors have an upper and/or lower limb impairment (Barker 1997), and impairment of the arm explains up to 50% of the variance in functional limitation after stroke. Brain imaging research using magnetoencephalography found that mirror therapy combined with bilateral arm training could potentially aid stroke rehabilitation by normalizing an asymmetrical pattern of movement-related beta desynchronization in primary motor cortex. However, different neural mechanisms may cause different effect of motor control recovery after the two different approaches, which have yet to be studied. Study purpose：To compare the efficacy of mirror therapy and bilateral arm training on movement strategies of the affected upper extremity and functional outcome in chronic stroke patients. Study method: This was a single-blind, randomized, comparative efficacy research. Sixty participants with chronic stroke will be recruited in the occupational therapy clinics at four hospitals and randomly assigned to the mirror therapy and bilateral arm training groups. The intervention will consist of 1.5 hrs/day, 5 days/wk for 4 wks, including 3 days of hospital-based therapy and 5 days of home practice. Primary outcomes were muscular properties (grip strength) and sensorimotor measurements. Secondary outcomes included measures of daily functions to gain insight about movement capabilities. The validity and reliability of all measurements have been proposed. Finally, the Mann-Whitney U test and the Fisher exact test will be used to compare the significant differences between the two approaches. The effect size of dependent variables will be reported also.

Eligibility criteria: Inclusion Criteria:

* more than 6 months after onset of an ischemic or hemorrhage stroke
* no excessive spasticity on all joints of the affected arm

Exclusion Criteria:

* history of stroke or other neurologic, neuromuscular, or orthopedic disease
* participation in other experimental rehabilitation or drug studies concurrent with this study

Primary outcomes:
measure: The efficacy of mirror therapy versus bilateral arm training on sensorimotor functions
timeFrame: within four weeks (plus or minus 3 days) after intervention
Secondary outcomes:
measure: The efficacy of mirror therapy versus bilateral arm training on motor performance
timeFrame: within four weeks (plus or minus 3 days) after intervention
measure: The efficacy of mirror therapy versus bilateral arm training on motor performance
timeFrame: within four weeks (plus or minus 3 days) after intervention
measure: The efficacy of mirror therapy versus bilateral arm training on quality of life
timeFrame: within four weeks (plus or minus 3 days) after intervention
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: National Taiwan University
name: Keh-Chung Lin, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thieme H, Mehrholz J, Pohl M, Behrens J, Dohle C. Mirror therapy for improving motor function after stroke. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD008449. doi: 10.1002/14651858.CD008449.pub2.
citation: Wu CY, Huang PC, Chen YT, Lin KC, Yang HW. Effects of mirror therapy on motor and sensory recovery in chronic stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2013 Jun;94(6):1023-30. doi: 10.1016/j.apmr.2013.02.007. Epub 2013 Feb 15.
citation: Samuelkamaleshkumar S, Reethajanetsureka S, Pauljebaraj P, Benshamir B, Padankatti SM, David JA. Mirror therapy enhances motor performance in the paretic upper limb after stroke: a pilot randomized controlled trial. Arch Phys Med Rehabil. 2014 Nov;95(11):2000-5. doi: 10.1016/j.apmr.2014.06.020. Epub 2014 Jul 23.
citation: Wolf A, Scheiderer R, Napolitan N, Belden C, Shaub L, Whitford M. Efficacy and task structure of bimanual training post stroke: a systematic review. Top Stroke Rehabil. 2014 May-Jun;21(3):181-96. doi: 10.1310/tsr2103-181.