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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04813120
• Other study ID #: 202002234A3
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: August 2023
• Source: Chang Gung Memorial Hospital
• Contact: Yu-Wei Hsieh, PhD
• Phone: +886-3-2118800
• Email: ywhsieh[@]mail.cgu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The specific study aims will be:

1. 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.

2. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Part ?: 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

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Cerebrovascular Disorders
• Nervous System Diseases
• Stroke

Intervention

Behavioral:
• Uni-MVF condition and unimanual training mode using the new MT system (UM-UT)
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.
• Uni-MVF condition and bimanual training mode using the new MT system (UM-BT)
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.
• Bi-MVF condition and bimanual training mode using the new MT system (BM-BT)
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.
• Traditional MT using a mirror box
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 a?ected arm and hand. In this group, the patient's affected arm and hand inside the mirror box will not need to move.

Locations

Country	Name	City	State
Taiwan	Lo-Sheng Sanatorium and Hospital	Taoyuan City	Taoyuan
Taiwan	Taoyuan Chang Gung Memorial Hospital	Taoyuan City

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	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.	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
Primary	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.	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
Secondary	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.	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
Secondary	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.	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
Secondary	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.	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
Secondary	change scores of Barthel Index	The Barthel Index is a validated tool designed to measure activities reflecting the daily living independence.	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
Secondary	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.	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
Secondary	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.	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
Secondary	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.	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)