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Enhanced Reality for Hemiparetic Arm in the Stroke Patients

U

Ulsan University Hospital

Status

Unknown

Conditions

Stroke
Mirror Movement
Paresis

Treatments

Other: No Enhanced reality
Device: Enhanced reality

Study type

Interventional

Funder types

Other

Identifiers

NCT03270852
chhwang8

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

38 participants in 2 patient groups

Enhanced reality
Experimental group
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.
Treatment:
Device: Enhanced reality
No Enhanced reality
Active Comparator group
Description:
Patients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes.
Treatment:
Other: No Enhanced reality

Trial contacts and locations

1

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Central trial contact

Chang Ho Hwang

Data sourced from clinicaltrials.gov

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