NCT04236089

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 4, 2021

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

January 17, 2020

Last Update Submit

March 3, 2021

Conditions

Keywords

mirror therapyrobotic mirror therapyElectroencephalographystroke

Outcome Measures

Primary Outcomes (1)

  • Electroencephalography assessment

    Compare the brainwave of the different interventions through Fourier Transform

    1.5hours

Secondary Outcomes (1)

  • Questionnaire

    30 minutes

Study Arms (4)

mirror therapy of healthy adults

NO INTERVENTION

Traditional mirror therapy in electroencephalography of healthy adults.

robotic mirror therapy of healthy adults

EXPERIMENTAL

Robotic mirror therapy in electroencephalography of healthy adults.

Device: robotic hand

mirror therapy of stroke patients

NO INTERVENTION

Traditional mirror therapy in electroencephalography of stroke patients.

robotic mirror therapy of stroke patients

EXPERIMENTAL

Robotic mirror therapy in electroencephalography of stroke patients.

Device: robotic hand

Interventions

mirror therapy with robotic hand

robotic mirror therapy of healthy adultsrobotic mirror therapy of stroke patients

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adults: right handed, with normal upper extremity and cognition functions
  • stroke patients:one side upper limb spasticity

You may not qualify if:

  • \. wrist weakness or deformity 2. skin problem 3. musculoskeletal injury of upper extremities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 22, 2020

Study Start

February 1, 2020

Primary Completion

November 30, 2020

Study Completion

December 31, 2020

Last Updated

March 4, 2021

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations