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

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

Study Overview

• Status: Unknown
• Conditions: Stroke; Cerebral Vascular Accident
• Intervention / Treatment: Device: RAPAELⓇ Smart Glove digital treatment system; Behavioral: Additional occupational therapy

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).

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yangsan, Korea, Republic of, 626-770
    • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RAPAELⓇ Smart Glove group; The experimental group includes 40 stroke patients. The group will receive the conventional occupational therapy(30min per session, 5 times per week, during 4 weeks of hand dexterity training) and RAPAELⓇ Smart Glove digital treatment system training. RAPAELⓇ Smart Glove digital treatment training will consist of games and play to facilitate the function of upper limbs and brain plasticity. RAPAELⓇ Smart Glove group will be provided the 20 training session. (30min per session, 5 times per week, during 4 weeks)	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.
Active Comparator: Additional occupation therapy group; The active comparator group includes 40 stroke patients.The occupational therapy group will receive the conventional occupational therapy(30min per session, 5 times per week, during 4 weeks of hand dexterity training) sessions twice. Additional conventional occupational therapy sessions are comprised of the training for upper limb and cognition. The additional occupational therapy group will be provided the 20 additional session (30min per session, 5 times per week, during 4 weeks)	Behavioral: Additional occupational therapy; 30 minutes of additional conventional occupational therapy session composed of hand dexteriy training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in upper extremity function (FMA)	Fugl-Meyer Assessment(FMA) of upper extremity	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in brain plasticity (fMRI)	fMRI	baseline and 4 weeks and 8 weeks
Change in brain plasticity (fNIRS)	Functional near-infrared spectroscopy(fNIRS)	baseline and 4 weeks and 8 weeks
Change in upper extremity function (MEP)	Measured by Motor evoked potential(MEP)	baseline and 4 weeks and 8 weeks
Change in upper extremity function(MMT&ROM)	Measured by manual muscle test(MMT) & range of motion(ROM)	baseline and 2,4,8 weeks
Change in activities of daily livings (MI)	Motricity index(MI)	baseline and 2,4,8 weeks
Change in upper extremity function (ARAT)	Action Research Arm test(ARAT)	baseline and 2,4,8 weeks
Change in upper extremity function (Box&Block test)	Box&Block test	baseline and 2,4,8 weeks
Change in upper extremity function (9-hole pegboard test)	9-hole pegboard test	baseline and 2,4,8 weeks
Change in upper extremity function (Jebson-Taylor Hand Function Test)	Jebson-Taylor Hand Function Test	baseline and 2,4,8 weeks
Change in upper extremity function (Modified Ashworth scale)	Modified Ashworth scale	baseline and 2,4,8 weeks
Change in upper extremity function (Grip strength test)	Grip strength test	baseline and 2,4,8 weeks
Change in upper extremity function (Grasp/Pinch power)	Grasp/Pinch power	baseline and 2,4,8 weeks
Change in upper extremity sensory function (VAS)	Visual Analogue Scale(VAS)	from baseline to 2 weeks after each 10 session and 4 weeks after final the session
Change in upper extremity sensory function (Two point discrimination and Monofilament)	Two point discrimination and Monofilament	baseline and 2,4,8 weeks
Change in activities of daily livings (K-MBI)	Korean version of Modified Barthel index(K-MBI)	baseline and 2,4,8 weeks
Change in cognition function (K-MMSE)	Korean-mini mental state examination(K-MMSE)	baseline and 2,4,8 weeks
Change in depressive mood (K-GDS)	Korean-Geriatric Depression Scale(K-GDS)	baseline and 2,4,8 weeks
Change in quality of life (SF-8)	Short form-8(SF-8)	baseline and 2,4,8 weeks
Change in upper extremity function (FMA)	Fugl-Meyer Assessment(FMA) of upper extremity	baseline and 2,4,8 weeks

Collaborators and Investigators

• Sponsor: Pusan National University
• Collaborators: Samsung Medical Center; NEOFECT Rehabilitation Solutions; Sungkyunkwan University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: April 12, 2015
• First Submitted That Met QC Criteria: April 27, 2015
• First Posted (Estimate): May 1, 2015

Study Record Updates

• Last Update Posted (Estimate): May 1, 2015
• Last Update Submitted That Met QC Criteria: April 27, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Upper limbs; RAPAELⓇ Smart Glove digital treatment system
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: PNUYH-03-2015-002