NCT02431390

Upper Limb Biofeedback Rehabilitation System (RAPAELⓇ Smart Glove Digital Treatment System) Training for Stroke Recovery

Effect of RAPAELⓇ Smart Glove Digital Treatment System on Upper Limb Functional Recovery and Brain Plasticity in Stroke Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Pusan National University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Stroke
• Cerebral Vascular Accident

Interventions

Type	Name	Description
DEVICE	RAPAELⓇ 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.
BEHAVIORAL	Additional occupational therapy	30 minutes of additional conventional occupational therapy session composed of hand dexteriy training

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2015-05-01
• Last updated: 2015-05-01

Locations

1 site across 1 country: South Korea