Enhanced Reality for Hemiparetic Arm in the Stroke Patients

Stroke Clinical Trial

Official title:

Enhanced Reality for Hemiparetic Arm in the Stroke Patients; Randomized Case-controlled Clinical Trial for Efficacy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03270852
• Other study ID #: chhwang8
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: August 2019
• Source: Ulsan University Hospital
• Contact: Chang Ho Hwang
• Phone: +82-52-250-7210
• Email: chhwang1220ciba[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mirror Movement
• Paresis
• Stroke

Intervention

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.

Other:
• No Enhanced reality
Identical rehabilitation without enhanced reality

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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