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Enhanced Reality for Hemiparetic Arm in the Stroke Patients

Primary Purpose

Stroke, Paresis, Mirror Movement

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Enhanced reality
No Enhanced reality
Sponsored by
Ulsan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ulsan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced reality

No Enhanced reality

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change of Jebsen Taylor test
Jebsen-Taylor Hand Function Test

Secondary Outcome Measures

Change of Arm motor Fugl-Mayer scale
Arm motor Fugl-Mayer scale; wrist & hand/proximal arm

Full Information

First Posted
August 30, 2017
Last Updated
August 30, 2019
Sponsor
Ulsan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03270852
Brief Title
Enhanced Reality for Hemiparetic Arm in the Stroke Patients
Official Title
Enhanced Reality for Hemiparetic Arm in the Stroke Patients; Randomized Case-controlled Clinical Trial for Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ulsan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Paresis, Mirror Movement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced reality
Arm Type
Experimental
Arm Description
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.
Arm Title
No Enhanced reality
Arm Type
Active Comparator
Arm Description
Patients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes.
Intervention Type
Device
Intervention Name(s)
Enhanced reality
Intervention Description
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
Other
Intervention Name(s)
No Enhanced reality
Intervention Description
Identical rehabilitation without enhanced reality
Primary Outcome Measure Information:
Title
Change of Jebsen Taylor test
Description
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 Outcome Measure Information:
Title
Change of Arm motor Fugl-Mayer scale
Description
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 Pre-specified Outcome Measures:
Title
Change of Ashworth scale
Description
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
Title
Change of 9-hole pegboard
Description
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
Title
Change of Stroke impact scale
Description
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
Title
Change of Grasp force in Newtons
Description
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
Title
Change of Active range of motion of wrist joint
Description
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
Title
Change of Korean-modified Barthel index
Description
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
Title
Change of motor evoked potential of abdutor pollicis brevis
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang Ho Hwang
Phone
+82-52-250-7210
Email
chhwang1220ciba@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Ho Hwang, M.D., Ph.D.
Organizational Affiliation
Ulsan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
682-714
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Ho Hwang, M.D., Ph.D.
Phone
+82-52-250-7210
Email
chhwang1220ciba@gmail.com
First Name & Middle Initial & Last Name & Degree
Chang Ho Hwang, M.D., Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhanced Reality for Hemiparetic Arm in the Stroke Patients

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