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

Not yet recruiting

Phase N/A Results N/A

Trial Description

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

Interventions

  • RAPAELⓇ Smart Glove digital treatment system Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: RAPAELⓇ Smart Glove 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)
  • Additional occupational therapy Behavioral
    Intervention Desc: 30 minutes of additional conventional occupational therapy session composed of hand dexteriy training
    ARM 1: Kind: Experimental
    Label: Additional occupation therapy 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)

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in upper extremity function (FMA) 2 weeks No
Secondary Change in brain plasticity (fMRI) baseline and 4 weeks and 8 weeks No
Secondary Change in brain plasticity (fNIRS) baseline and 4 weeks and 8 weeks No
Secondary Change in upper extremity function (MEP) baseline and 4 weeks and 8 weeks No
Secondary Change in upper extremity function(MMT&ROM) baseline and 2,4,8 weeks No
Secondary Change in activities of daily livings (MI) baseline and 2,4,8 weeks No
Secondary Change in upper extremity function (ARAT) baseline and 2,4,8 weeks No
Secondary Change in upper extremity function (Box&Block test) baseline and 2,4,8 weeks No
Secondary Change in upper extremity function (9-hole pegboard test) baseline and 2,4,8 weeks No
Secondary Change in upper extremity function (Jebson-Taylor Hand Function Test) baseline and 2,4,8 weeks No
Secondary Change in upper extremity function (Modified Ashworth scale) baseline and 2,4,8 weeks No
Secondary Change in upper extremity function (Grip strength test) baseline and 2,4,8 weeks No
Secondary Change in upper extremity function (Grasp/Pinch power) baseline and 2,4,8 weeks No
Secondary Change in upper extremity sensory function (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) baseline and 2,4,8 weeks No
Secondary Change in activities of daily livings (K-MBI) baseline and 2,4,8 weeks No
Secondary Change in cognition function (K-MMSE) baseline and 2,4,8 weeks No
Secondary Change in depressive mood (K-GDS) baseline and 2,4,8 weeks No
Secondary Change in quality of life (SF-8) baseline and 2,4,8 weeks No

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