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

NCT ID: NCT02431390

Last Updated: 2015-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-03-31

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).

Conditions

Stroke; Cerebral Vascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

RAPAELⓇ Smart Glove digital treatment system

Intervention Type: DEVICE

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.

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)

Group Type: ACTIVE_COMPARATOR

Additional occupational therapy

Intervention Type: BEHAVIORAL

30 minutes of additional conventional occupational therapy session composed of hand dexteriy training

Interventions

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.

Intervention Type: DEVICE

Additional occupational therapy

30 minutes of additional conventional occupational therapy session composed of hand dexteriy training

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: collaborator

Sungkyunkwan University

OTHER

Sponsor Role: collaborator

NEOFECT Rehabilitation Solutions

OTHER

Sponsor Role: collaborator

Pusan National University

OTHER

Sponsor Role: lead

Responsible Party

Yong-il Shin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong-Il Shin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Countries

South Korea

Central Contacts

Yong-Il Shin, Ph.D.

Role: CONTACT

rmshin01@gmail.com

82-55-360-2872

Other Identifiers

PNUYH-03-2015-002

Identifier Type: -

Identifier Source: org_study_id