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

NCT02431390 | Unknown DMC

• 1 other identifier: PNUYH-03-2015-002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke; Cerebral Vascular Accident

Keywords

RAPAELⓇ Smart Glove digital treatment system; Rehabilitation; Stroke; Upper limbs

Outcome Measures

Primary Outcomes (1)

• Change in upper extremity function (FMA)

  Fugl-Meyer Assessment(FMA) of upper extremity

  2 weeks

Secondary Outcomes (19)

• Change in brain plasticity (fMRI)

  baseline and 4 weeks and 8 weeks

• Change in brain plasticity (fNIRS)

  baseline and 4 weeks and 8 weeks

• Change in upper extremity function (MEP)

  baseline and 4 weeks and 8 weeks

• Change in upper extremity function(MMT&ROM)

  baseline and 2,4,8 weeks

• Change in activities of daily livings (MI)

  baseline and 2,4,8 weeks

Study Arms (2)

RAPAELⓇ Smart Glove group

EXPERIMENTAL

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

Additional occupation therapy group

ACTIVE COMPARATOR

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

Interventions

RAPAELⓇ Smart Glove digital treatment system 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.

RAPAELⓇ Smart Glove group

Additional occupational therapy BEHAVIORAL

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

Additional occupation therapy group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who hemiplegic due to stroke
• Subjects who have more than 22 points of Fugl-Meyer Assessment score in upper extremity
• subjects who have diagnosed as stroke before 3weeks to 3 months(subacute)
• subjects who have diagnosed as stroke more than 6 months ago(chronic)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University: lead
• Samsung Medical Center: collaborator
• Sungkyunkwan University: collaborator
• NEOFECT Rehabilitation Solutions: collaborator

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, 626-770, South Korea

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yong-Il Shin, Ph.D.

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong-Il Shin, Ph.D.

CONTACT

82-55-360-2872; rmshin01@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 12, 2015
• First Posted: May 1, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 1, 2015

Record last verified: 2015-04

Locations

KR (1)