Enhanced Reality for Hemiparetic Arm in the Stroke Patients

NCT ID: NCT03270852

Last Updated: 2019-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-13

Study Completion Date

2021-10-31

Brief Summary

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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

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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

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Stroke Paresis Mirror Movement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Enhanced reality

Intervention Type DEVICE

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 reality

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

Group Type ACTIVE_COMPARATOR

No Enhanced reality

Intervention Type OTHER

Identical rehabilitation without enhanced reality

Interventions

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Enhanced 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.

Intervention Type DEVICE

No Enhanced reality

Identical rehabilitation without enhanced reality

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ulsan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Ho Hwang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang Ho Hwang, M.D., Ph.D.

Role: STUDY_DIRECTOR

Ulsan University Hospital

Locations

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Ulsan University Hospital

Ulsan, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Chang Ho Hwang

Role: CONTACT

+82-52-250-7210

Facility Contacts

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Chang Ho Hwang, M.D., Ph.D.

Role: primary

+82-52-250-7210

Other Identifiers

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chhwang8

Identifier Type: -

Identifier Source: org_study_id

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