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

Not Applicable

• Conditions: Stroke; Cerebral Vascular Accident
• Interventions: Device: RAPAELⓇ Smart Glove digital treatment system; Behavioral: Additional occupational therapy

• Registration Number: NCT02431390
• Lead Sponsor: Pusan National University

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).

Study Timeline

• Status Verified: 2015-04
• Study First Submitted: 2015-04-12
• Study First Submitted QC: 2015-04-27
• Last Update Submitted: 2015-04-27
• Study Start: 2015-05
• Study First Posted: 2015-05-01
• Last Update Posted: 2015-05-01
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RAPAELⓇ Smart Glove group	RAPAELⓇ Smart Glove digital treatment system	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)
Additional occupation therapy group	Additional occupational therapy	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)

Primary Outcome Measures

Name	Time	Method
Change in upper extremity function (FMA)	2 weeks	Fugl-Meyer Assessment(FMA) of upper extremity

Secondary Outcome Measures

Name	Time	Method
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 brain plasticity (fMRI)	baseline and 4 weeks and 8 weeks	fMRI
Change in upper extremity function (FMA)	baseline and 2,4,8 weeks	Fugl-Meyer Assessment(FMA) of upper extremity
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 (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 upper extremity function (Grip strength test)	baseline and 2,4,8 weeks	Grip strength test
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)

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Korea, Republic of