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

Pusan National University

Status: Unknown

Conditions: Cerebral Vascular Accident; Stroke

Treatments: Behavioral: Additional occupational therapy; Device: RAPAELⓇ Smart Glove digital treatment system

Study type: Interventional

Funder types: Other

Identifiers

NCT02431390

PNUYH-03-2015-002

Details and patient eligibility

About

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

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

RAPAELⓇ Smart Glove group

Experimental group

Description:

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)

Treatment:

Device: RAPAELⓇ Smart Glove digital treatment system

Additional occupation therapy group

Active Comparator group

Description:

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)

Treatment:

Behavioral: Additional occupational therapy