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

Pusan National University80 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke Cerebral Vascular Accident

Interventions

RAPAELⓇ Smart Glove digital treatment systemDEVICE

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.

Additional occupational therapyBEHAVIORAL

30 minutes of additional conventional occupational therapy session composed of hand dexteriy training

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Pusan National University Yangsan Hospital

Yangsan, South Korea

Outcomes

Primary Outcomes

Change in upper extremity function (FMA)

Fugl-Meyer Assessment(FMA) of upper extremity

Time frame: 2 weeks

Secondary Outcomes

Change in brain plasticity (fMRI)

fMRI

Time frame: baseline and 4 weeks and 8 weeks

Change in brain plasticity (fNIRS)

Functional near-infrared spectroscopy(fNIRS)

Time frame: baseline and 4 weeks and 8 weeks

Change in upper extremity function (MEP)

Measured by Motor evoked potential(MEP)

Time frame: baseline and 4 weeks and 8 weeks

Change in upper extremity function(MMT&ROM)

Measured by manual muscle test(MMT) \& range of motion(ROM)

Time frame: baseline and 2,4,8 weeks

Change in activities of daily livings (MI)

Motricity index(MI)

Time frame: baseline and 2,4,8 weeks

Change in upper extremity function (ARAT)

Action Research Arm test(ARAT)

Time frame: baseline and 2,4,8 weeks

Change in upper extremity function (Box&Block test)

Box\&Block test

Time frame: baseline and 2,4,8 weeks

Change in upper extremity function (9-hole pegboard test)

Central Contacts

Yong-Il Shin, Ph.D.

CONTACT

82-55-360-2872 rmshin01@gmail.com

Data from ClinicalTrials.gov

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