StrokeNCT02431390
Upper Limb Biofeedback Rehabilitation System (RAPAELⓇ Smart Glove Digital Treatment System) Training for Stroke Recovery
A study testing RAPAELⓇ Smart Glove digital treatment system and Additional occupational therapy in people with Stroke and Cerebral Vascular Accident, run by Pusan National University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Cerebral Vascular Accident
- What is being tested?
- RAPAELⓇ Smart Glove digital treatment system and Additional occupational therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, 626-770
About this study
Official title: 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
Read the 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:
- Primary outcome. -Fugl-Meyer assessment,
- 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)
- Activity of daily living. Korean version of Modified Barthel index (K-MBI)
- Cognition function test. Korean-mini mental state examination (K-MMSE)
- Depressive mood. Korean-Geriatric Depression Scale (K-GDS)
- Quality of life. Short form-8(SF-8)
- Neuroimaging tools. Motor evoked potentials (MEP), Functional Magnetic Resonance Imaging (fMRI), Functional near-infrared spectroscopy (fNIRS).
- Conditions
- Stroke, Cerebral Vascular Accident
- Being tested
- RAPAELⓇ Smart Glove digital treatment system, Additional occupational therapy
- Keywords
- RAPAELⓇ Smart Glove digital treatment system, Rehabilitation, Stroke, Upper limbs
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAPAELⓇ Smart Glove digital treatment systemDevice
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 occupational therapyBehavioural
30 minutes of additional conventional occupational therapy session composed of hand dexteriy training
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Behavioral: Additional occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in upper extremity function (FMA)
Fugl-Meyer Assessment(FMA) of upper extremity
Measured: 2 weeks
Secondary outcomes (19)
Change in brain plasticity (fMRI)
fMRI
Measured: baseline and 4 weeks and 8 weeks
Change in brain plasticity (fNIRS)
Functional near-infrared spectroscopy(fNIRS)
Measured: baseline and 4 weeks and 8 weeks
Change in upper extremity function (MEP)
Measured by Motor evoked potential(MEP)
Measured: baseline and 4 weeks and 8 weeks
Change in upper extremity function(MMT&ROM)
Measured by manual muscle test(MMT) \& range of motion(ROM)
Measured: baseline and 2,4,8 weeks
Change in activities of daily livings (MI)
Motricity index(MI)
Measured: baseline and 2,4,8 weeks
Change in upper extremity function (ARAT)
Action Research Arm test(ARAT)
Measured: baseline and 2,4,8 weeks
Change in upper extremity function (Box&Block test)
Box\&Block test
Measured: baseline and 2,4,8 weeks
Change in upper extremity function (9-hole pegboard test)
9-hole pegboard test
Measured: baseline and 2,4,8 weeks
Change in upper extremity function (Jebson-Taylor Hand Function Test)
Jebson-Taylor Hand Function Test
Measured: baseline and 2,4,8 weeks
Change in upper extremity function (Modified Ashworth scale)
Modified Ashworth scale
Measured: baseline and 2,4,8 weeks
Change in upper extremity function (Grip strength test)
Grip strength test
Measured: baseline and 2,4,8 weeks
Change in upper extremity function (Grasp/Pinch power)
Grasp/Pinch power
Measured: baseline and 2,4,8 weeks
Change in upper extremity sensory function (VAS)
Visual Analogue Scale(VAS)
Measured: 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)
Two point discrimination and Monofilament
Measured: baseline and 2,4,8 weeks
Change in activities of daily livings (K-MBI)
Korean version of Modified Barthel index(K-MBI)
Measured: baseline and 2,4,8 weeks
Change in cognition function (K-MMSE)
Korean-mini mental state examination(K-MMSE)
Measured: baseline and 2,4,8 weeks
Change in depressive mood (K-GDS)
Korean-Geriatric Depression Scale(K-GDS)
Measured: baseline and 2,4,8 weeks
Change in quality of life (SF-8)
Short form-8(SF-8)
Measured: baseline and 2,4,8 weeks
Change in upper extremity function (FMA)
Fugl-Meyer Assessment(FMA) of upper extremity
Measured: baseline and 2,4,8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Sungkyunkwan University, NEOFECT Rehabilitation Solutions
- Responsible party
- Principal investigator, Yong-il Shin, Pusan National University
- Investigators
- Yong-Il Shin, Ph.D., Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431390
- Sponsor's protocol ID
- PNUYH-03-2015-002
- Status last verified
- Apr 2015
- First submitted
- 12 Apr 2015
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of RAPAELⓇ Smart Glove Digital Treatment System on Upper Limb Functional Recovery and Brain Plasticity in Stroke Patients
- ClinicalTrials.gov ID
- NCT02431390
- Acronym / sponsor ID
- PNUYH-03-2015-002
- Conditions
- Stroke, Cerebral Vascular Accident
- Keywords
- RAPAELⓇ Smart Glove digital treatment system, Rehabilitation, Stroke, Upper limbs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pusan National UniversityUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Sungkyunkwan University, NEOFECT Rehabilitation Solutions
- Study start
- May 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 1 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Primary outcome. -Fugl-Meyer assessment,
- 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)
- Activity of daily living. Korean version of Modified Barthel index (K-MBI)
- Cognition function test. Korean-mini mental state examination (K-MMSE)
- Depressive mood. Korean-Geriatric Depression Scale (K-GDS)
- Quality of life. Short form-8(SF-8)
- Neuroimaging tools. Motor evoked potentials (MEP), Functional Magnetic Resonance Imaging (fMRI), Functional near-infrared spectroscopy (fNIRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAPAELⓇ Smart Glove group | Experimental | Device: RAPAELⓇ Smart Glove digital treatment systemThe 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 occupation therapy group | Active comparator | Behavioral: Additional occupational therapyThe 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) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAPAELⓇ Smart Glove digital treatment systemThe 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. | Device | RAPAELⓇ Smart Glove group |
| Additional occupational therapy30 minutes of additional conventional occupational therapy session composed of hand dexteriy training | Behavioural | Additional occupation therapy group |
Primary outcome
Change in upper extremity function (FMA)
Time frame: 2 weeks
Fugl-Meyer Assessment(FMA) of upper extremity
19 secondary outcomes
Change in brain plasticity (fMRI)
Time frame: baseline and 4 weeks and 8 weeks
Change in brain plasticity (fNIRS)
Time frame: baseline and 4 weeks and 8 weeks
Change in upper extremity function (MEP)
Time frame: baseline and 4 weeks and 8 weeks
Change in upper extremity function(MMT&ROM)
Time frame: baseline and 2,4,8 weeks
Change in activities of daily livings (MI)
Time frame: baseline and 2,4,8 weeks
Change in upper extremity function (ARAT)
Time frame: baseline and 2,4,8 weeks
Change in upper extremity function (Box&Block test)
Time frame: baseline and 2,4,8 weeks
Change in upper extremity function (9-hole pegboard test)
Time frame: baseline and 2,4,8 weeks
Change in upper extremity function (Jebson-Taylor Hand Function Test)
Time frame: baseline and 2,4,8 weeks
Change in upper extremity function (Modified Ashworth scale)
Time frame: baseline and 2,4,8 weeks
Change in upper extremity function (Grip strength test)
Time frame: baseline and 2,4,8 weeks
Change in upper extremity function (Grasp/Pinch power)
Time frame: 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
Change in upper extremity sensory function (Two point discrimination and Monofilament)
Time frame: baseline and 2,4,8 weeks
Change in activities of daily livings (K-MBI)
Time frame: baseline and 2,4,8 weeks
Change in cognition function (K-MMSE)
Time frame: baseline and 2,4,8 weeks
Change in depressive mood (K-GDS)
Time frame: baseline and 2,4,8 weeks
Change in quality of life (SF-8)
Time frame: baseline and 2,4,8 weeks
Change in upper extremity function (FMA)
Time frame: baseline and 2,4,8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong-Il Shin, Ph.D. principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAPAELⓇ Smart Glove digital treatment system and Additional occupational therapy in people with Stroke and Cerebral Vascular Accident, run by Pusan National University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong-Il Shin, Ph.D. (82-55-360-2872, rmshin01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in upper extremity function (FMA) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2015.