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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04236089
Other study ID # 201900537A3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date December 31, 2020

Study information

Verified date January 2020
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Mirror therapy has recently attracted increasing attention; however, most patients have the difficulties to perform mirror therapy due to limited imaginary ability. A mirror robotic hand system was developed, which consisted with a wearable exoskeletal hand, sensor glove, and a control box. The patient's unaffected hand wears the sensor glove, the affected hand wears the wearable exoskeleton hand, and the unaffected hand does the certain transitive and intransitive tasks as the mirror group, and then makes the affected hand do the same movements driven by the exoskeleton robotic hand. The investigators hypothesize that combining both approaches might facilitate the sensorimotor cortex that controls movement and might augment somatosensory input and further treatment efficacy. This study is aimed at investigating the effects of Mirror therapy and robotic mirror therapy on motor cortical activations in healthy adults and stroke patients using electroencephalography. All participants will perform the conditions of resting, moving right hand with or without robotic hand as the baseline data, then they will do mirror therapy using the right hand as active hand, or wearing robotic hand doing mirror therapy in random sequence. Electroencephalography (EEG) assessment will be done to assess the neurophysiologic effects of the different interventions. The investigators will use a questionnaire to assess the subjective opinion about the different interventions. combined with execution (video AOE). The investigators will use the pair-t test to assess the within subjects differences in EEG and the questionnaire results. This study will be done during 2020/02/01 - 2021/03/31.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date December 31, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: - healthy adults: right handed, with normal upper extremity and cognition functions - stroke patients:one side upper limb spasticity Exclusion Criteria: - 1. wrist weakness or deformity 2. skin problem 3. musculoskeletal injury of upper extremities

Study Design


Related Conditions & MeSH terms


Intervention

Device:
robotic hand
mirror therapy with robotic hand

Locations

Country Name City State
Taiwan Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Electroencephalography assessment Compare the brainwave of the different interventions through Fourier Transform 1.5hours
Secondary Questionnaire Collect the subjective opinion about the different interventions 30 minutes
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