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

• Sponsor: Pusan National University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02431390
• Collaborator: Samsung Medical Center (Other), Sungkyunkwan University (Other), NEOFECT Rehabilitation Solutions (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Stroke; Cerebral Vascular Accident	Device: RAPAELⓇ Smart Glove digital treatment system; Behavioral: Additional occupational therapy	N/A

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,

1. 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)

2. Activity of daily living. Korean version of Modified Barthel index (K-MBI)

3. Cognition function test. Korean-mini mental state examination (K-MMSE)

4. Depressive mood. Korean-Geriatric Depression Scale (K-GDS)

5. Quality of life. Short form-8(SF-8)

6. Neuroimaging tools. Motor evoked potentials (MEP), Functional Magnetic Resonance Imaging (fMRI), Functional near-infrared spectroscopy (fNIRS).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of RAPAELⓇ Smart Glove Digital Treatment System on Upper Limb Functional Recovery and Brain Plasticity in Stroke Patients
• Study Start Date: May 1, 2015
• Anticipated Primary Completion Date: Mar 1, 2017
• Anticipated Study Completion Date: Mar 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in upper extremity function (FMA) [2 weeks]

   Fugl-Meyer Assessment(FMA) of upper extremity

Secondary Outcome Measures

1. Change in brain plasticity (fMRI) [baseline and 4 weeks and 8 weeks]

   fMRI

2. Change in brain plasticity (fNIRS) [baseline and 4 weeks and 8 weeks]

   Functional near-infrared spectroscopy(fNIRS)

3. Change in upper extremity function (MEP) [baseline and 4 weeks and 8 weeks]

   Measured by Motor evoked potential(MEP)

4. Change in upper extremity function(MMT&ROM) [baseline and 2,4,8 weeks]

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

5. Change in activities of daily livings (MI) [baseline and 2,4,8 weeks]

   Motricity index(MI)

6. Change in upper extremity function (ARAT) [baseline and 2,4,8 weeks]

   Action Research Arm test(ARAT)

7. Change in upper extremity function (Box&Block test) [baseline and 2,4,8 weeks]

   Box&Block test

8. Change in upper extremity function (9-hole pegboard test) [baseline and 2,4,8 weeks]

   9-hole pegboard test

9. Change in upper extremity function (Jebson-Taylor Hand Function Test) [baseline and 2,4,8 weeks]

   Jebson-Taylor Hand Function Test

10. Change in upper extremity function (Modified Ashworth scale) [baseline and 2,4,8 weeks]

    Modified Ashworth scale

11. Change in upper extremity function (Grip strength test) [baseline and 2,4,8 weeks]

    Grip strength test

12. Change in upper extremity function (Grasp/Pinch power) [baseline and 2,4,8 weeks]

    Grasp/Pinch power

13. 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)

14. Change in upper extremity sensory function (Two point discrimination and Monofilament) [baseline and 2,4,8 weeks]

    Two point discrimination and Monofilament

15. Change in activities of daily livings (K-MBI) [baseline and 2,4,8 weeks]

    Korean version of Modified Barthel index(K-MBI)

16. Change in cognition function (K-MMSE) [baseline and 2,4,8 weeks]

    Korean-mini mental state examination(K-MMSE)

17. Change in depressive mood (K-GDS) [baseline and 2,4,8 weeks]

    Korean-Geriatric Depression Scale(K-GDS)

18. Change in quality of life (SF-8) [baseline and 2,4,8 weeks]

    Short form-8(SF-8)

19. Change in upper extremity function (FMA) [baseline and 2,4,8 weeks]

    Fugl-Meyer Assessment(FMA) of upper extremity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pusan National University Yangsan Hospital	Yangsan		Korea, Republic of	626-770

Sponsors and Collaborators

• Pusan National University
• Samsung Medical Center
• Sungkyunkwan University
• NEOFECT Rehabilitation Solutions

Investigators

• Principal Investigator: Yong-Il Shin, Ph.D., Pusan National University Yangsan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yong-il Shin, Associate Professor, Pusan National University
• ClinicalTrials.gov Identifier: NCT02431390
• Other Study ID Numbers: PNUYH-03-2015-002
• First Posted: May 1, 2015
• Last Update Posted: May 1, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Yong-il Shin, Associate Professor, Pusan National University: RAPAELⓇ Smart Glove digital treatment system; Rehabilitation; Stroke; Upper limbs
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of May 1, 2015