Upper Limb Biofeedback Rehabilitation System (RAPAELⓇ Smart Glove Digital Treatment System) Training for Stroke Recovery
Upper Limb Biofeedback Rehabilitation System (RAPAELⓇ Smart Glove Digital Treatment System) Training for Stroke Recovery
This study is to investigate whether the RAPAELⓇ Smart Glove digital treatment system
 improves the upper extremity function of stroke patients compared to other clinical treatment
 by measuring serial behavioral and neuroimaging assessments and to find out therapeutic
 effect or adverse effect and patient's feed back responses
80 stroke patients(subacute=40, chronic=40) were recruited and randomized to receive either
 occupation therapy(OT) with or without RAPAELⓇ Smart Glove digital therapy. Groups were
 divided as follow: Group 1 (5times/4wks, total 20 sessions) Conventional occupation therapy +
 additional occupation therapy(30min). Group 2 (5times/4wks, total 20 sessions) Conventional
 occupation therapy + RAPAELⓇ Smart Glove digital treatment(30min).

 After the baseline assessment, patients are divided into two groups by drawing for simple
 random sampling. Total four times of behavioral and neuroimaging assessments were evaluated
 at baseline, immediately and 2 weeks after each 10 sessions and at 4 weeks after the final
 session. Assessment tools are as follow:

 1. Primary outcome.

 -Fugl-Meyer assessment,

 2. Motor and sensory function. MMT&ROM, Motricity index(MI),Action Research Arm test(ARAT),
 Box&block test, Box&Block test, 9-hole pegboard test, Jebsen-Taylor hand function test,
 Modified Ashworth scale(MAS), Grip strength test, Grasp/pinch power, Visual analogue
 scale(VAS), Sensory test(two point discrimination, monofilament)

 3. Activity of daily living. Korean version of Modified Barthel index (K-MBI)

 4. Cognition function test. Korean-mini mental state examination (K-MMSE)

 5. Depressive mood. Korean-Geriatric Depression Scale (K-GDS)

 6. Quality of life. Short form-8(SF-8)

 7. Neuroimaging tools. Motor evoked potentials (MEP), Functional Magnetic Resonance Imaging
 (fMRI), Functional near-infrared spectroscopy (fNIRS).
Inclusion Criteria:

 -  Subjects who hemiplegic due to stroke

 -  Subjects who have more than 22 points of Fugl-Meyer Assessment score in upper
 extremity

 -  40 subjects who have diagnosed as stroke before 3weeks to 3 months(subacute)

 -  40 subjects who have diagnosed as stroke more than 6 months ago(chronic)

 Exclusion Criteria:

 -  Subjects who have spasticity and upper extremity dysfunction at unaffected side

 -  Subjects who have bilateral or multiple brain lesion

 -  Subjects who have non-controllable medial or surgical disease

 -  Subjects who is less than 20 years old

 -  Subjects who have pre-existing and active major neurological or psychiatric disease

 -  Subjects who have less than 10 degrees of active wrist range of motion

 -  Subjects who can not complete outcome measurement task

 -  Subjects who have limitation of communication due to aphasia

 -  Subjects who have less than 17 points of K-MMSE

 -  Subjects who is pregnant

 -  Subjects who have pain or other muscle wasting disease which may interrupt upper
 extremity exercise