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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03270852
Enrollment
38
Registered
2017-09-01
Start date
2019-06-13
Completion date
2021-10-31
Last updated
2019-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mirror Movement, Paresis, Stroke

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.

Interventions

DEVICEEnhanced 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.

OTHERNo Enhanced reality

Identical rehabilitation without enhanced reality

Sponsors

Ulsan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Jebsen Taylor test1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatmentJebsen-Taylor Hand Function Test

Secondary

MeasureTime frameDescription
Change of Arm motor Fugl-Mayer scale1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatmentArm motor Fugl-Mayer scale; wrist & hand/proximal arm

Other

MeasureTime frameDescription
Change of Stroke impact scale1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatmentStroke impact scale, hand function
Change of Grasp force in Newtons1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatmentGrasp force in Newtons
Change of Ashworth scale1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatmentAshworth scale; wrist/ elbow
Change of Korean-modified Barthel index1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatmentKorean version-Modified Barthel Index
Change of motor evoked potential of abdutor pollicis brevis1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatmentMotor Evoked Potential
Change of Active range of motion of wrist joint1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatmentrange of motion of the wrist joint
Change of 9-hole pegboard1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment9-hole pegboard

Countries

South Korea

Contacts

Primary ContactChang Ho Hwang
chhwang1220ciba@gmail.com+82-52-250-7210

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026