Cerebral Vascular Accident, Stroke
Conditions
Keywords
RAPAELⓇ Smart Glove digital treatment system, Rehabilitation, Stroke, Upper limbs
Brief summary
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
Detailed description
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).
Interventions
DEVICERAPAELⓇ Smart Glove digital treatment system
The RAPAELⓇ Smart Glove digital treatment system is constituted for stroke rehabilitation. For use, stroke patients wear the gloves and play the games or puzzle for rehabilitation of upper limbs. The system provides biofeedback to user.
BEHAVIORALAdditional occupational therapy
30 minutes of additional conventional occupational therapy session composed of hand dexteriy training
Sponsors
Samsung Medical Center
Sungkyunkwan University
NEOFECT Rehabilitation Solutions
Pusan National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in upper extremity function (FMA) | 2 weeks | Fugl-Meyer Assessment(FMA) of upper extremity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in brain plasticity (fNIRS) | baseline and 4 weeks and 8 weeks | Functional near-infrared spectroscopy(fNIRS) |
| Change in upper extremity function (MEP) | baseline and 4 weeks and 8 weeks | Measured by Motor evoked potential(MEP) |
| Change in upper extremity function(MMT&ROM) | baseline and 2,4,8 weeks | Measured by manual muscle test(MMT) & range of motion(ROM) |
| Change in activities of daily livings (MI) | baseline and 2,4,8 weeks | Motricity index(MI) |
| Change in upper extremity function (ARAT) | baseline and 2,4,8 weeks | Action Research Arm test(ARAT) |
| Change in upper extremity function (Box&Block test) | baseline and 2,4,8 weeks | Box&Block test |
| Change in upper extremity function (9-hole pegboard test) | baseline and 2,4,8 weeks | 9-hole pegboard test |
| Change in upper extremity function (Jebson-Taylor Hand Function Test) | baseline and 2,4,8 weeks | Jebson-Taylor Hand Function Test |
| Change in upper extremity function (Modified Ashworth scale) | baseline and 2,4,8 weeks | Modified Ashworth scale |
| Change in brain plasticity (fMRI) | baseline and 4 weeks and 8 weeks | fMRI |
| Change in upper extremity function (Grasp/Pinch power) | baseline and 2,4,8 weeks | Grasp/Pinch power |
| Change in upper extremity sensory function (VAS) | from baseline to 2 weeks after each 10 session and 4 weeks after final the session | Visual Analogue Scale(VAS) |
| Change in upper extremity sensory function (Two point discrimination and Monofilament) | baseline and 2,4,8 weeks | Two point discrimination and Monofilament |
| Change in activities of daily livings (K-MBI) | baseline and 2,4,8 weeks | Korean version of Modified Barthel index(K-MBI) |
| Change in cognition function (K-MMSE) | baseline and 2,4,8 weeks | Korean-mini mental state examination(K-MMSE) |
| Change in depressive mood (K-GDS) | baseline and 2,4,8 weeks | Korean-Geriatric Depression Scale(K-GDS) |
| Change in quality of life (SF-8) | baseline and 2,4,8 weeks | Short form-8(SF-8) |
| Change in upper extremity function (FMA) | baseline and 2,4,8 weeks | Fugl-Meyer Assessment(FMA) of upper extremity |
| Change in upper extremity function (Grip strength test) | baseline and 2,4,8 weeks | Grip strength test |
Countries
South Korea
Contacts
Primary ContactYong-Il Shin, Ph.D.
Outcome results
None listed