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

April 27, 2015 updated by: Yong-il Shin, Pusan National University

Effect of RAPAELⓇ Smart Glove Digital Treatment System on Upper Limb Functional Recovery and Brain Plasticity in Stroke Patients

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Yangsan, Korea, Republic of, 626-770
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in upper extremity function (FMA)
Time Frame: 2 weeks
Fugl-Meyer Assessment(FMA) of upper extremity
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in brain plasticity (fMRI)
Time Frame: baseline and 4 weeks and 8 weeks
fMRI
baseline and 4 weeks and 8 weeks
Change in brain plasticity (fNIRS)
Time Frame: baseline and 4 weeks and 8 weeks
Functional near-infrared spectroscopy(fNIRS)
baseline and 4 weeks and 8 weeks
Change in upper extremity function (MEP)
Time Frame: baseline and 4 weeks and 8 weeks
Measured by Motor evoked potential(MEP)
baseline and 4 weeks and 8 weeks
Change in upper extremity function(MMT&ROM)
Time Frame: baseline and 2,4,8 weeks
Measured by manual muscle test(MMT) & range of motion(ROM)
baseline and 2,4,8 weeks
Change in activities of daily livings (MI)
Time Frame: baseline and 2,4,8 weeks
Motricity index(MI)
baseline and 2,4,8 weeks
Change in upper extremity function (ARAT)
Time Frame: baseline and 2,4,8 weeks
Action Research Arm test(ARAT)
baseline and 2,4,8 weeks
Change in upper extremity function (Box&Block test)
Time Frame: baseline and 2,4,8 weeks
Box&Block test
baseline and 2,4,8 weeks
Change in upper extremity function (9-hole pegboard test)
Time Frame: baseline and 2,4,8 weeks
9-hole pegboard test
baseline and 2,4,8 weeks
Change in upper extremity function (Jebson-Taylor Hand Function Test)
Time Frame: baseline and 2,4,8 weeks
Jebson-Taylor Hand Function Test
baseline and 2,4,8 weeks
Change in upper extremity function (Modified Ashworth scale)
Time Frame: baseline and 2,4,8 weeks
Modified Ashworth scale
baseline and 2,4,8 weeks
Change in upper extremity function (Grip strength test)
Time Frame: baseline and 2,4,8 weeks
Grip strength test
baseline and 2,4,8 weeks
Change in upper extremity function (Grasp/Pinch power)
Time Frame: baseline and 2,4,8 weeks
Grasp/Pinch power
baseline and 2,4,8 weeks
Change in upper extremity sensory function (VAS)
Time Frame: from baseline to 2 weeks after each 10 session and 4 weeks after final the session
Visual Analogue Scale(VAS)
from baseline to 2 weeks after each 10 session and 4 weeks after final the session
Change in upper extremity sensory function (Two point discrimination and Monofilament)
Time Frame: baseline and 2,4,8 weeks
Two point discrimination and Monofilament
baseline and 2,4,8 weeks
Change in activities of daily livings (K-MBI)
Time Frame: baseline and 2,4,8 weeks
Korean version of Modified Barthel index(K-MBI)
baseline and 2,4,8 weeks
Change in cognition function (K-MMSE)
Time Frame: baseline and 2,4,8 weeks
Korean-mini mental state examination(K-MMSE)
baseline and 2,4,8 weeks
Change in depressive mood (K-GDS)
Time Frame: baseline and 2,4,8 weeks
Korean-Geriatric Depression Scale(K-GDS)
baseline and 2,4,8 weeks
Change in quality of life (SF-8)
Time Frame: baseline and 2,4,8 weeks
Short form-8(SF-8)
baseline and 2,4,8 weeks
Change in upper extremity function (FMA)
Time Frame: baseline and 2,4,8 weeks
Fugl-Meyer Assessment(FMA) of upper extremity
baseline and 2,4,8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pusan National University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Samsung Medical Center
NEOFECT Rehabilitation Solutions
Sungkyunkwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PNUYH-03-2015-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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