Clinical trial NCT03270852: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Paresis
Mirror Movement
Lead sponsor: Ulsan University Hospital
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of Jebsen Taylor test
timeFrame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
Secondary outcomes:
measure: Change of Arm motor Fugl-Mayer scale
timeFrame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
Other outcomes:
measure: Change of Ashworth scale
timeFrame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
measure: Change of 9-hole pegboard
timeFrame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
measure: Change of Stroke impact scale
timeFrame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
measure: Change of Grasp force in Newtons
timeFrame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
measure: Change of Active range of motion of wrist joint
timeFrame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
measure: Change of Korean-modified Barthel index
timeFrame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
measure: Change of motor evoked potential of abdutor pollicis brevis
timeFrame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Ulsan University Hospital
name: Chang Ho Hwang, M.D., Ph.D.
role: STUDY_DIRECTOR
References: