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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02431390
• Other study ID #: PNUYH-03-2015-002
• Status: Not yet recruiting
• Phase: N/A
• First received: April 12, 2015
• Last updated: April 27, 2015
• Start date: May 2015
• Est. completion date: March 2017

Study information

• Verified date: April 2015
• Source: Pusan National University School of Medicine
• Contact: Yong-Il Shin, Ph.D.
• Phone: 82-55-360-2872
• Email: rmshin01[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Vascular Accident
• Stroke

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (4)

Lead Sponsor	Collaborator
Pusan National University School of Medicine	Neofect, Samsung Medical Center, Sungkyunkwan University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in upper extremity function (FMA)	Fugl-Meyer Assessment(FMA) of upper extremity	2 weeks	No
Secondary	Change in brain plasticity (fMRI)	fMRI	baseline and 4 weeks and 8 weeks	No
Secondary	Change in brain plasticity (fNIRS)	Functional near-infrared spectroscopy(fNIRS)	baseline and 4 weeks and 8 weeks	No
Secondary	Change in upper extremity function (MEP)	Measured by Motor evoked potential(MEP)	baseline and 4 weeks and 8 weeks	No
Secondary	Change in upper extremity function(MMT&ROM)	Measured by manual muscle test(MMT) & range of motion(ROM)	baseline and 2,4,8 weeks	No
Secondary	Change in activities of daily livings (MI)	Motricity index(MI)	baseline and 2,4,8 weeks	No
Secondary	Change in upper extremity function (ARAT)	Action Research Arm test(ARAT)	baseline and 2,4,8 weeks	No
Secondary	Change in upper extremity function (Box&Block test)	Box&Block test	baseline and 2,4,8 weeks	No
Secondary	Change in upper extremity function (9-hole pegboard test)	9-hole pegboard test	baseline and 2,4,8 weeks	No
Secondary	Change in upper extremity function (Jebson-Taylor Hand Function Test)	Jebson-Taylor Hand Function Test	baseline and 2,4,8 weeks	No
Secondary	Change in upper extremity function (Modified Ashworth scale)	Modified Ashworth scale	baseline and 2,4,8 weeks	No
Secondary	Change in upper extremity function (Grip strength test)	Grip strength test	baseline and 2,4,8 weeks	No
Secondary	Change in upper extremity function (Grasp/Pinch power)	Grasp/Pinch power	baseline and 2,4,8 weeks	No
Secondary	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	No
Secondary	Change in upper extremity sensory function (Two point discrimination and Monofilament)	Two point discrimination and Monofilament	baseline and 2,4,8 weeks	No
Secondary	Change in activities of daily livings (K-MBI)	Korean version of Modified Barthel index(K-MBI)	baseline and 2,4,8 weeks	No
Secondary	Change in cognition function (K-MMSE)	Korean-mini mental state examination(K-MMSE)	baseline and 2,4,8 weeks	No
Secondary	Change in depressive mood (K-GDS)	Korean-Geriatric Depression Scale(K-GDS)	baseline and 2,4,8 weeks	No
Secondary	Change in quality of life (SF-8)	Short form-8(SF-8)	baseline and 2,4,8 weeks	No
Secondary	Change in upper extremity function (FMA)	Fugl-Meyer Assessment(FMA) of upper extremity	baseline and 2,4,8 weeks	No