Enhanced Reality for Hemiparetic Arm in the Stroke Patients

Not Applicable

• Conditions: Paresis; Stroke; Mirror Movement
• Interventions: Other: No Enhanced reality; Device: Enhanced reality

• Registration Number: NCT03270852
• Lead Sponsor: Ulsan University Hospital

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.

Study Timeline

• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-01
• Study Start: 2019-06-13
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-30
• Last Update Posted: 2019-09-03
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Enhanced reality	No Enhanced reality	Patients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes.
Enhanced reality	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.

Primary Outcome Measures

Name	Time	Method
Change of Jebsen Taylor test	1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment	Jebsen-Taylor Hand Function Test

Secondary Outcome Measures

Name	Time	Method
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	Arm motor Fugl-Mayer scale; wrist \& hand/proximal arm

Trial Locations

Locations (1)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of