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Digital Mirror Therapy With Uni- and Bilateral Mirror Visual Feedback After Stroke: Treatment Effects and EEG Evidence

Primary Purpose

Stroke, Cerebrovascular Disorders, Central Nervous System Diseases

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Uni-MVF condition and unimanual training mode using the new MT system (UM-UT)

Uni-MVF condition and bimanual training mode using the new MT system (UM-BT)

Bi-MVF condition and bimanual training mode using the new MT system (BM-BT)

Traditional MT using a mirror box

About this trial

This is an interventional other trial for Stroke focused on measuring digital rehabilitation, cerebrovascular accident, mirror visual feedback, brain electrophysiology

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Part Ⅰ: Validation of Treatment Efficacy of the New Digital MT System with Different MVF Conditions and Training Modes

Inclusion Criteria:

diagnosed with a unilateral stroke;
at least 6 months after stroke onset;
age between 20 and 80 years old;
having a baseline score of Fugl-Meyer Assessment (FMA) in a range of 20 to 60;
able to follow the study instructions;
capable of participating in therapy and assessment sessions

Exclusion Criteria:

global or receptive aphasia;
severe neglect measured by line bisection test;
other major medical diseases or comorbidities that have influenced upper-limb usage or caused severe pain

Part II: Investigation of the Electrophysiological Mechanisms Underlying Different MVF Conditions by EEG

Inclusion Criteria:

diagnosed with a unilateral stroke;
at least 2 weeks after stroke onset and medical stable;
aged 20 to 80 years;
having a baseline score of FMA ≥ 40 and wrist flexion ≥ 20 degrees in order to perform EEG motor tasks;
both wrist flexion and extension scores of Modified Ashworth Scale ≤ 1;
able to follow the study instructions

Exclusion Criteria:

global or receptive aphasia;
severe neglect measured by line bisection test;
other major medical diseases or comorbidities, such as neurological and psychiatric diseases, that have caused severe pain of upper-limb or interfered brain neural activities

Sites / Locations

Lo-Sheng Sanatorium and HospitalRecruiting
Taoyuan Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Uni-MVF condition and unimanual training mode using the new MT system (UM-UT)

Uni-MVF condition and bimanual training mode using the new MT system (UM-BT)

Bi-MVF condition and bimanual training mode using the new MT system (BM-BT)

Traditional MT using a mirror box

Arm Description

The following common categories of upper-limb movements and actions will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movements, and (c) object manipulation.

Outcomes

Primary Outcome Measures

Change scores of Fugl-Meyer Assessment

The upper-limb subsection of Fugl-Meyer Assessment is a measure with sound psychometric properties to evaluate motor impairments.

Change scores of Chedoke Arm and Hand Activity Inventory

The Chedoke Arm and Hand Activity Inventory is a reliable and validated measure to assess the independence of stroke patients to perform activities of daily living with an affected upper limb.

Secondary Outcome Measures

change scores of Box and Block Test

The Box and Block Test is a tool with sound reliability and validity to evaluate hand dexterity of stroke patients.

change scores of Revised Nottingham Sensory Assessment

The Revised Nottingham Sensory Assessment is a standardized measure with good reliability to assess sensory function in patients with stroke.

change scores of Movement Imagery Questionnaire-Revised, Second Edition

The Movement Imagery Questionnaire-Revised, Second Edition is a 14-item questionnaire with sound reliability and validity to evaluate the ability of motion imagination in patients with stroke.

change scores of Barthel Index

The Barthel Index is a validated tool designed to measure activities reflecting the daily living independence.

change scores of Motor Activity Log

The Motor Activity Log is a semi-structured interview with good psychometric properties to assess the level of use of affected upper limb in 30 main activities of daily living.

change scores of the health state of EQ-5D-5L

The questionnaire of EQ-5D-5L contains 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and uses a 5-point Likert scale scored from 1 (no problem) to 5 (unable to/extreme problems); whereas, the numerical description of 5 dimensions represents the health state.

change scores of the visual analogue scale (VAS) of EQ-5D-5L

The VAS of EQ-5D-5L scores will be scored from 0 to 100, with a higher score indicating better overall current health.

Full Information

NCT ID

NCT04813120

First Posted

March 21, 2021

Last Updated

August 28, 2023

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04813120

Brief Title

Digital Mirror Therapy With Uni- and Bilateral Mirror Visual Feedback After Stroke: Treatment Effects and EEG Evidence

Official Title

The Use of a New Digital Mirror Therapy System Providing Unilateral and Bilateral Mirror Visual Feedback for Patients With Stroke: Treatment Effects and EEG-physiological Evidence

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

July 31, 2024 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The specific study aims will be: To examine the treatment effects of a new digital mirror therapy (MT) system versus a mirror box in patients with stroke by conducting a 4-group randomized controlled trial. To examine the electrophysiological mechanisms of uni-mirror visual feedback (uni-MVF) condition with unimanual training mode, uni-MVF condition with bimanual training mode, and bi-MVF condition with bimanual training mode in the new MT system by EEG.

Detailed Description

Part I: Validation of Treatment Efficacy of the New Digital MT System with Different MVF Conditions and Training Modes In this new MT system, 3 different types of MT in different MVF conditions and training modes can be provided: unilateral MVF with unimanual training mode (UM-UT), unilateral MVF with bimanual training mode (UM-BT), and bilateral MVF with bimanual training mode (BM-BT). In the part Ⅰ study, an estimated total of 80 patients with stroke will be recruited. In addition to the original rehabilitation interventions of patients, each participant will be randomly allocated to 1 of 4 intervention groups (i.e., UM-UT, UM-BT, BM-BT, or traditional MT using a mirror box) for 15-hour therapy sessions. Outcome measures will be administrated at pre-treatment, immediately after treatment, and at 1-month follow-up after treatment. Part II: Investigation of the Electrophysiological Mechanisms Underlying Different MVF Conditions by EEG Twenty stroke patients will be recruited for examining the brain electrophysiological mechanisms underlying different types of MVF and training conditions of this new system by using electroencephalography (EEG). Three experimental conditions, including UM-UT, UM-BT, and BM-BT conditions, will be conducted in the EEG study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Cerebrovascular Disorders, Central Nervous System Diseases

Keywords

digital rehabilitation, cerebrovascular accident, mirror visual feedback, brain electrophysiology

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Uni-MVF condition and unimanual training mode using the new MT system (UM-UT)

Arm Type

Experimental

Arm Description

Arm Title

Uni-MVF condition and bimanual training mode using the new MT system (UM-BT)

Arm Type

Experimental

Arm Description

Arm Title

Bi-MVF condition and bimanual training mode using the new MT system (BM-BT)

Arm Type

Experimental

Arm Description

Arm Title

Traditional MT using a mirror box

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Uni-MVF condition and unimanual training mode using the new MT system (UM-UT)

Intervention Description

For the UM-UT group, the participants will be seated in front of the new MT system, and will be instructed to watch the real-time image reflection of movements of the non-affected arm and hand on the screen carefully. At the same time, the patients will need to imagine that the movements were performed by their affected arm and hand. In this group, only the non-affected arm and hand will need to perform the movements, but the affected one will not need to move.

Intervention Type

Behavioral

Intervention Name(s)

Uni-MVF condition and bimanual training mode using the new MT system (UM-BT)

Intervention Description

During the UM-BT, as similar as the first group (UM-UT), the participants will be also seated in front of the new MT system, and be instructed to watch the real-time image reflection of the non-affected arm and hand's movements on the screen carefully and imagine that the movements were performed by the affected arm. However, in this UM-BT group, the bilateral training mode is emphasized, and thus both arms and hands will need to move. That is, during therapy, the patient's affected arm and hand will be required to move at his/her best motor ability with the non-affected arm and hand at the same time.

Intervention Type

Behavioral

Intervention Name(s)

Bi-MVF condition and bimanual training mode using the new MT system (BM-BT)

Intervention Description

For the BM-BT group, the participants will be seated in front of this new MT system, and be instructed to observe the real-time image reflection of the non-affected arm and hand's movements transformed and superimposed on both arms and hands (i.e., bi-MVF), and to imagine that the movements were performed by both arms and hands. In this group, bi-MVF and bilateral training mode are emphasized, and thus both arms and hands will also need to move. The patient's affected arm and hand will be required to move as could as possible simultaneously.

Intervention Type

Behavioral

Intervention Name(s)

Traditional MT using a mirror box

Intervention Description

During traditional MT, the participants will be seated in front of a mirror box placed at their mid-sagittal plane. The affected arm and hand of the participants will be placed inside the mirror box, and the non-affected arm and hand will be in front of the mirror. As similar to the UM-UT group, the participants will be instructed to watch the mirror reflection of the movements performed by the non-affected arm and hand carefully and to imagine that the movements were performed by the aﬀected arm and hand. In this group, the patient's affected arm and hand inside the mirror box will not need to move.

Primary Outcome Measure Information:

Title

Change scores of Fugl-Meyer Assessment

Description

The upper-limb subsection of Fugl-Meyer Assessment is a measure with sound psychometric properties to evaluate motor impairments.

Time Frame

baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)

Title

Change scores of Chedoke Arm and Hand Activity Inventory

Description

The Chedoke Arm and Hand Activity Inventory is a reliable and validated measure to assess the independence of stroke patients to perform activities of daily living with an affected upper limb.

Time Frame

baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)

Secondary Outcome Measure Information:

Title

change scores of Box and Block Test

Description

The Box and Block Test is a tool with sound reliability and validity to evaluate hand dexterity of stroke patients.

Time Frame

baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)

Title

change scores of Revised Nottingham Sensory Assessment

Description

The Revised Nottingham Sensory Assessment is a standardized measure with good reliability to assess sensory function in patients with stroke.

Time Frame

baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)

Title

change scores of Movement Imagery Questionnaire-Revised, Second Edition

Description

The Movement Imagery Questionnaire-Revised, Second Edition is a 14-item questionnaire with sound reliability and validity to evaluate the ability of motion imagination in patients with stroke.

Time Frame

baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)

Title

change scores of Barthel Index

Description

The Barthel Index is a validated tool designed to measure activities reflecting the daily living independence.

Time Frame

baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)

Title

change scores of Motor Activity Log

Description

The Motor Activity Log is a semi-structured interview with good psychometric properties to assess the level of use of affected upper limb in 30 main activities of daily living.

Time Frame

baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)

Title

change scores of the health state of EQ-5D-5L

Description

Time Frame

baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)

Title

change scores of the visual analogue scale (VAS) of EQ-5D-5L

Description

The VAS of EQ-5D-5L scores will be scored from 0 to 100, with a higher score indicating better overall current health.

Time Frame

baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Part Ⅰ: Validation of Treatment Efficacy of the New Digital MT System with Different MVF Conditions and Training Modes Inclusion Criteria: diagnosed with a unilateral stroke; at least 6 months after stroke onset; age between 20 and 80 years old; having a baseline score of Fugl-Meyer Assessment (FMA) in a range of 20 to 60; able to follow the study instructions; capable of participating in therapy and assessment sessions Exclusion Criteria: global or receptive aphasia; severe neglect measured by line bisection test; other major medical diseases or comorbidities that have influenced upper-limb usage or caused severe pain Part II: Investigation of the Electrophysiological Mechanisms Underlying Different MVF Conditions by EEG Inclusion Criteria: diagnosed with a unilateral stroke; at least 2 weeks after stroke onset and medical stable; aged 20 to 80 years; having a baseline score of FMA ≥ 40 and wrist flexion ≥ 20 degrees in order to perform EEG motor tasks; both wrist flexion and extension scores of Modified Ashworth Scale ≤ 1; able to follow the study instructions Exclusion Criteria: global or receptive aphasia; severe neglect measured by line bisection test; other major medical diseases or comorbidities, such as neurological and psychiatric diseases, that have caused severe pain of upper-limb or interfered brain neural activities

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yu-Wei Hsieh, PhD

Phone

+886-3-2118800

Ext

3820

ywhsieh@mail.cgu.edu.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yu-Wei Hsieh, PhD

Organizational Affiliation

Department of Occupational Therapy, College of Medicine, Chang Gung University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lo-Sheng Sanatorium and Hospital

City

Taoyuan City

State/Province

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yu-Wei Hsieh, PhD

Phone

+88632118800

Ext

3820

ywhsieh@mail.cgu.edu.tw

Facility Name

Taoyuan Chang Gung Memorial Hospital

City

Taoyuan City

ZIP/Postal Code

333

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yu-Wei Hsieh, PhD

Phone

+886-3-2118800

Ext

3820

ywhsieh@mail.cgu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Digital Mirror Therapy With Uni- and Bilateral Mirror Visual Feedback After Stroke: Treatment Effects and EEG Evidence

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