StrokeNCT03270852
Enhanced Reality for Hemiparetic Arm in the Stroke Patients
A study testing Enhanced reality and No Enhanced reality in people with Stroke and Paresis, run by Ulsan University Hospital at 1 site in South Korea.
Trial summary
The researchers found that enhanced reality developed for the first time in the word by us had a synergistic or additive effect on brain plasticity in patients without central nervous system injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Paresis, Mirror Movement
- What is being tested?
- Enhanced reality and No Enhanced reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jun 2019to 31 Oct 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arm motor Fugl-Mayer scale; wrist/hand subscales ≥ 2-20
- 9-hole pegboard ; ≥ 25% of contra-lateral hand
Who cannot join
- Alexander apraxia scale ≤2
- NIH stroke scale question Ia-c ≥1
- Nottingham sensory scale; <75% of contra-lateral hand
- Ashworth scale ≥3
- NIH stroke scale question IX ≥2
- Beck depression inventory ≥21
Show all 9Show fewer
- Significant upper extremity disease causing hand or below elbow dysfunction
- Visual disturbance
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ulsan University Hospital
Ulsan, 682-714
Chang Ho Hwang, M.D., Ph.D., +82-52-250-7210, chhwang1220ciba@gmail.com
Chang Ho Hwang, M.D., Ph.D.
About this study
Official title: Enhanced Reality for Hemiparetic Arm in the Stroke Patients; Randomized Case-controlled Clinical Trial for Efficacy
The researchers found that enhanced reality developed for the first time in the word by us had a synergistic or additive effect on brain plasticity in patients without central nervous system injury. The aim of this study is to determine the validity and feasibility of enhanced reality in hemiparetic arm in the stroke patients with central nervous system injury.
Read the detailed description
Pre-interventional evaluation; within 1 day of initiation of the intervention; 10 days after initiation of the intervention; 30 days after termination of treatment.
- Conditions
- Stroke, Paresis, Mirror Movement
- Being tested
- Enhanced reality, No Enhanced reality
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced realityDevice
This prototype is developed by investigators for the first time so that it have no trademark or manufacturer name yet.
The patient sits facing the horizontal desk with the ER therapy device, and then raises the wrist joint to the fixed base. The hand, wrist, and distal forearm to be treated are positioned below the ER medical camera so that the wrist is visible on the screen. Fix the wrist and wrist joint using Velcro. When treating the distal forearm, detach the wrist fixing Velcro.
No Enhanced realityOther
Identical rehabilitation without enhanced reality
| Study group | Role | What they receive |
|---|---|---|
| Enhanced reality | Experimental | Patients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes.
ER therapy is provided 2 times a day for 10 minutes for 2 weeks (10 days of treatment week), except for time of installation, calibration, and 3 minute breaks. Receives: Device: Enhanced reality |
| No Enhanced reality | Active comparator | Patients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes. Receives: Other: No Enhanced reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Jebsen Taylor test
Jebsen-Taylor Hand Function Test
Measured: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
Secondary outcomes (1)
Change of Arm motor Fugl-Mayer scale
Arm motor Fugl-Mayer scale; wrist \& hand/proximal arm
Measured: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start13 Jun 2019
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Ho Hwang, Ulsan University Hospital
- Investigators
- Chang Ho Hwang, M.D., Ph.D., Study director, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270852
- Sponsor's protocol ID
- chhwang8
- Status last verified
- Aug 2019
- First submitted
- 30 Aug 2017
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Reality for Hemiparetic Arm in the Stroke Patients; Randomized Case-controlled Clinical Trial for Efficacy
- ClinicalTrials.gov ID
- NCT03270852
- Acronym / sponsor ID
- chhwang8
- Conditions
- Stroke, Paresis, Mirror Movement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 1 Sep 2017 (actual)
- 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.
The researchers found that enhanced reality developed for the first time in the word by us had a synergistic or additive effect on brain plasticity in patients without central nervous system injury. The aim of this study is to determine the validity and feasibility of enhanced reality in hemiparetic arm in the stroke patients with central nervous system injury.
Detailed description
Pre-interventional evaluation; within 1 day of initiation of the intervention; 10 days after initiation of the intervention; 30 days after termination of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced reality | Experimental | Device: Enhanced realityPatients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes. ER therapy is provided 2 times a day for 10 minutes for 2 weeks (10 days of treatment week), except for time of installation, calibration, and 3 minute breaks. |
| No Enhanced reality | Active comparator | Other: No Enhanced realityPatients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Arm motor Fugl-Mayer scale; wrist/hand subscales ≥ 2-20
- 9-hole pegboard ; ≥ 25% of contra-lateral hand
Key exclusion criteria (9 listed)
- Alexander apraxia scale ≤2
- NIH stroke scale question Ia-c ≥1
- Nottingham sensory scale; <75% of contra-lateral hand
- Ashworth scale ≥3
- NIH stroke scale question IX ≥2
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 |
|---|---|---|
| Enhanced realityThis prototype is developed by investigators for the first time so that it have no trademark or manufacturer name yet. The patient sits facing the horizontal desk with the ER therapy device, and then raises the wrist joint to the fixed base. The hand, wrist, and distal forearm to be treated are positioned below the ER medical camera so that the wrist is visible on the screen. Fix the wrist and wrist joint using Velcro. When treating the distal forearm, detach the wrist fixing Velcro. | Device | Enhanced reality |
| No Enhanced realityIdentical rehabilitation without enhanced reality | Other | No Enhanced reality |
Primary outcome
Change of Jebsen Taylor test
Time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
Jebsen-Taylor Hand Function Test
1 secondary outcome
Change of Arm motor Fugl-Mayer scale
Time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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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.
Chang Ho Hwang, M.D., Ph.D. study director
Ulsan University 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 Enhanced reality and No Enhanced reality in people with Stroke and Paresis, run by Ulsan University Hospital 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 2 inclusion and 9 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 3 Sep 2019. 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 Chang Ho Hwang (+82-52-250-7210, chhwang1220ciba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Jebsen Taylor test (time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment). 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 3 Sep 2019.