ClinicalTrials.gg
Status unknownNCT03270852Updated Sep 3, 2019

Enhanced Reality for Hemiparetic Arm in the Stroke Patients

An interventional study of Enhanced reality and No Enhanced reality in Stroke, Paresis and Mirror Movement, sponsored by Ulsan University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-03.

Sponsored by Ulsan University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 279 studies in Stroke with a site in Korea, Republic of — 41 open to participants now, 49 under way, 2 of them phase 3. Stroke · Korea, Republic of.

Planned enrollment
128th of 215
38 · median 50
Started
2019
with 18 others
No phase
137 of 279
15 open now
Registered
117th of 279
by date

Among the 279 studies in Stroke with a site in Korea, Republic of, this one is the 128th largest by planned enrollment of the 215 interventional ones that give a count, is one of 19 that started in 2019, is one of 137 with no phase, and was the 117th registered.

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 38 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Open to participants now

41 of the 279 studies in Stroke with a site in Korea, Republic of are open now, in 12 countries. Each count lists the studies.

All 41 open studies →

Who these studies take

Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 279 studies in Stroke with a site in Korea, Republic of, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Stroke
  • Paresis
  • Mirror Movement

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Arm motor Fugl-Mayer scale; wrist/hand subscales ≥ 2-20
  • 9-hole pegboard ; ≥ 25% of contra-lateral hand

Exclusion criteria

Exclusion Criteria:

  • 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
  • Significant upper extremity disease causing hand or below elbow dysfunction
  • Visual disturbance
  • Refusal of participation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    Enhanced reality

    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.

    Device: Enhanced reality

  • Active comparator
    No Enhanced reality

    Patients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes.

    Other: No Enhanced reality

Interventions

  • DeviceEnhanced reality

    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.

  • OtherNo Enhanced reality

    Identical rehabilitation without enhanced reality

06

What researchers measure

Primary outcomes

  1. Change of Jebsen Taylor test

    Jebsen-Taylor Hand Function Test

    Time frame: 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

    Time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment

Other outcomes

  1. Change of Ashworth scale

    Ashworth scale; wrist/ elbow

    Time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment

  2. Change of 9-hole pegboard

    9-hole pegboard

    Time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment

  3. Change of Stroke impact scale

    Stroke impact scale, hand function

    Time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment

  4. Change of Grasp force in Newtons

    Grasp force in Newtons

    Time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment

  5. Change of Active range of motion of wrist joint

    range of motion of the wrist joint

    Time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment

  6. Change of Korean-modified Barthel index

    Korean version-Modified Barthel Index

    Time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment

  7. Change of motor evoked potential of abdutor pollicis brevis

    Motor Evoked Potential

    Time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment

07

Study locations

1 of 1 sites recruiting
  • Ulsan University Hospital
    Ulsan, 682-714, Korea, Republic of
    Recruiting
    • Chang Ho Hwang, M.D., Ph.D. · Contactchhwang1220ciba@gmail.com · +82-52-250-7210
    • Chang Ho Hwang, M.D., Ph.D. · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2019 (actual). Primary completion is estimated for Oct 2021, 28 months after the start.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 28 months is above that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2017
First posted
Sep 1, 2017
StartActual
Jun 13, 2019
Primary completionEst.
Oct 31, 2021
CompletionEst.
Oct 31, 2021
Last update
Sep 3, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03270852
Lead sponsor
Ulsan University Hospital
Responsible party
Chang Ho Hwang (Principal Investigator, Ulsan University Hospital) — Principal investigator
First posted
Sep 1, 2017
Start date
Jun 13, 2019
Primary completion
Oct 31, 2021 (estimated)
Completion
Oct 31, 2021 (estimated)
Last update
Sep 3, 2019

Study contacts

Chang Ho Hwang
Contact
chhwang1220ciba@gmail.com
+82-52-250-7210
Chang Ho Hwang, M.D., Ph.D.
study director · Ulsan University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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