Enhanced Reality for Hemiparetic Arm in the Stroke Patients

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Paresis; Mirror Movement
• Intervention / Treatment: Device: Enhanced reality; Other: No Enhanced reality

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 Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chang Ho Hwang; Phone Number: +82-52-250-7210; Email: chhwang1220ciba@gmail.com

Study Locations

• Korea, Republic of
  • Ulsan, Korea, Republic of, 682-714
    • Recruiting
    • Ulsan University Hospital
    • Contact: Chang Ho Hwang, M.D., Ph.D.; Phone Number: +82-52-250-7210; Email: chhwang1220ciba@gmail.com
    • Principal Investigator: Chang Ho Hwang, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; Identical rehabilitation without enhanced reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Arm motor Fugl-Mayer scale	Arm motor Fugl-Mayer scale; wrist & hand/proximal arm	1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Ashworth scale	Ashworth scale; wrist/ elbow	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	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	Stroke impact scale, hand function	1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
Change of Grasp force in Newtons	Grasp force in Newtons	1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
Change of Active range of motion of wrist joint	range of motion of the wrist joint	1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
Change of Korean-modified Barthel index	Korean version-Modified Barthel Index	1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
Change of motor evoked potential of abdutor pollicis brevis	Motor Evoked Potential	1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment

Collaborators and Investigators

• Sponsor: Ulsan University Hospital
• Investigators: Study Director: Chang Ho Hwang, M.D., Ph.D., Ulsan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 30, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis
• Other Study ID Numbers: chhwang8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No