NCT03270852

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 13, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

2.4 years

First QC Date

August 30, 2017

Last Update Submit

August 30, 2019

Conditions

StrokeParesisMirror Movement

Outcome Measures

Primary Outcomes (1)

  • Change of Jebsen Taylor test

    Jebsen-Taylor Hand Function Test

    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

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

Other Outcomes (7)

  • Change of Ashworth scale

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

  • Change of 9-hole pegboard

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

  • Change of Stroke impact scale

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

  • +4 more other outcomes

Study Arms (2)

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.

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.

Other: No Enhanced reality

Interventions

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.

Enhanced reality
No Enhanced realityOTHER

Identical rehabilitation without enhanced reality

No Enhanced reality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulsan University Hospital

Ulsan, 682-714, South Korea

RECRUITING

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chang Ho Hwang, M.D., Ph.D.

    Ulsan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Chang Ho Hwang

CONTACT

+82-52-250-7210chhwang1220ciba@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 1, 2017

Study Start

June 13, 2019

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

September 3, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)