Clinical trial NCT02431390: Upper Limb Biofeedback Rehabilitation System (RAPAELⓇ Smart Glove Digital Treatment System) Training for Stroke Recovery
Official title: Effect of RAPAELⓇ Smart Glove Digital Treatment System on Upper Limb Functional Recovery and Brain Plasticity in Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Cerebral Vascular Accident
Keywords: RAPAELⓇ Smart Glove digital treatment system
Rehabilitation
Stroke
Upper limbs
Lead sponsor: Pusan National University
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Sungkyunkwan University
name: NEOFECT Rehabilitation Solutions
First posted: 2015-05-01
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in upper extremity function (FMA)
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in brain plasticity (fMRI)
timeFrame: baseline and 4 weeks and 8 weeks
measure: Change in brain plasticity (fNIRS)
timeFrame: baseline and 4 weeks and 8 weeks
measure: Change in upper extremity function (MEP)
timeFrame: baseline and 4 weeks and 8 weeks
measure: Change in upper extremity function(MMT&ROM)
timeFrame: baseline and 2,4,8 weeks
measure: Change in activities of daily livings (MI)
timeFrame: baseline and 2,4,8 weeks
measure: Change in upper extremity function (ARAT)
timeFrame: baseline and 2,4,8 weeks
measure: Change in upper extremity function (Box&Block test)
timeFrame: baseline and 2,4,8 weeks
measure: Change in upper extremity function (9-hole pegboard test)
timeFrame: baseline and 2,4,8 weeks
measure: Change in upper extremity function (Jebson-Taylor Hand Function Test)
timeFrame: baseline and 2,4,8 weeks
measure: Change in upper extremity function (Modified Ashworth scale)
timeFrame: baseline and 2,4,8 weeks
measure: Change in upper extremity function (Grip strength test)
timeFrame: baseline and 2,4,8 weeks
measure: Change in upper extremity function (Grasp/Pinch power)
timeFrame: baseline and 2,4,8 weeks
measure: Change in upper extremity sensory function (VAS)
timeFrame: from baseline to 2 weeks after each 10 session and 4 weeks after final the session
measure: Change in upper extremity sensory function (Two point discrimination and Monofilament)
timeFrame: baseline and 2,4,8 weeks
measure: Change in activities of daily livings (K-MBI)
timeFrame: baseline and 2,4,8 weeks
measure: Change in cognition function (K-MMSE)
timeFrame: baseline and 2,4,8 weeks
measure: Change in depressive mood (K-GDS)
timeFrame: baseline and 2,4,8 weeks
measure: Change in quality of life (SF-8)
timeFrame: baseline and 2,4,8 weeks
measure: Change in upper extremity function (FMA)
timeFrame: baseline and 2,4,8 weeks
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Yong-Il Shin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: