Compare Effects of the Mirror Therapy and Robotic Mirror Therapy in Electroencephalography of Healthy Adults and Stroke Patients.

NCT ID: NCT04236089

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2020-12-31

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.

Conditions

Healthy Adults; Stroke Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mirror therapy of healthy adults

Traditional mirror therapy in electroencephalography of healthy adults.

Group Type: NO_INTERVENTION

No interventions assigned to this group

robotic mirror therapy of healthy adults

Robotic mirror therapy in electroencephalography of healthy adults.

Group Type: EXPERIMENTAL

robotic hand

Intervention Type: DEVICE

mirror therapy with robotic hand

mirror therapy of stroke patients

Traditional mirror therapy in electroencephalography of stroke patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

robotic mirror therapy of stroke patients

Robotic mirror therapy in electroencephalography of stroke patients.

Group Type: EXPERIMENTAL

robotic hand

Intervention Type: DEVICE

mirror therapy with robotic hand

Interventions

robotic hand

mirror therapy with robotic hand

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

201900537A3

Identifier Type: -

Identifier Source: org_study_id