Compare Effects of the Mirror Therapy and Robotic Mirror Therapy in Electroencephalography of Healthy Adults and Stroke Patients.
Primary Purpose
Healthy Adults, Stroke Patients
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
robotic hand
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Adults focused on measuring mirror therapy, robotic mirror therapy, Electroencephalography, stroke
Eligibility Criteria
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
Sites / Locations
- Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
No Intervention
Experimental
Arm Label
mirror therapy of healthy adults
robotic mirror therapy of healthy adults
mirror therapy of stroke patients
robotic mirror therapy of stroke patients
Arm Description
Traditional mirror therapy in electroencephalography of healthy adults.
Robotic mirror therapy in electroencephalography of healthy adults.
Traditional mirror therapy in electroencephalography of stroke patients.
Robotic mirror therapy in electroencephalography of stroke patients.
Outcomes
Primary Outcome Measures
Electroencephalography assessment
Compare the brainwave of the different interventions through Fourier Transform
Secondary Outcome Measures
Questionnaire
Collect the subjective opinion about the different interventions
Full Information
NCT ID
NCT04236089
First Posted
January 17, 2020
Last Updated
March 3, 2021
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04236089
Brief Title
Compare Effects of the Mirror Therapy and Robotic Mirror Therapy in Electroencephalography of Healthy Adults and Stroke Patients.
Official Title
Compare Effects of the Mirror Therapy and Robotic Mirror Therapy in Electroencephalography of Healthy Adults and Stroke Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Adults, Stroke Patients
Keywords
mirror therapy, robotic mirror therapy, Electroencephalography, stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mirror therapy of healthy adults
Arm Type
No Intervention
Arm Description
Traditional mirror therapy in electroencephalography of healthy adults.
Arm Title
robotic mirror therapy of healthy adults
Arm Type
Experimental
Arm Description
Robotic mirror therapy in electroencephalography of healthy adults.
Arm Title
mirror therapy of stroke patients
Arm Type
No Intervention
Arm Description
Traditional mirror therapy in electroencephalography of stroke patients.
Arm Title
robotic mirror therapy of stroke patients
Arm Type
Experimental
Arm Description
Robotic mirror therapy in electroencephalography of stroke patients.
Intervention Type
Device
Intervention Name(s)
robotic hand
Intervention Description
mirror therapy with robotic hand
Primary Outcome Measure Information:
Title
Electroencephalography assessment
Description
Compare the brainwave of the different interventions through Fourier Transform
Time Frame
1.5hours
Secondary Outcome Measure Information:
Title
Questionnaire
Description
Collect the subjective opinion about the different interventions
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Compare Effects of the Mirror Therapy and Robotic Mirror Therapy in Electroencephalography of Healthy Adults and Stroke Patients.
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