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

Not Applicable

Completed

• Conditions: Stroke; Cerebrovascular Disorders; Central Nervous System Diseases
• Interventions: Behavioral: Traditional MT using a mirror box; Behavioral: Bi-MVF condition and bimanual training mode using the new MT system (BM-BT); Behavioral: Uni-MVF condition and unimanual training mode using the new MT system (UM-UT); Behavioral: Uni-MVF condition and bimanual training mode using the new MT system (UM-BT)

• Registration Number: NCT04813120
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

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.

Study Timeline

• Study First Submitted: 2021-03-21
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-24
• Study Start: 2021-08-01
• Status Verified: 2023-08
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional MT using a mirror box	Traditional MT using a mirror box	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.
Bi-MVF condition and bimanual training mode using the new MT system (BM-BT)	Bi-MVF condition and bimanual training mode using the new MT system (BM-BT)	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.
Uni-MVF condition and unimanual training mode using the new MT system (UM-UT)	Uni-MVF condition and unimanual training mode using the new MT system (UM-UT)	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.
Uni-MVF condition and bimanual training mode using the new MT system (UM-BT)	Uni-MVF condition and bimanual training mode using the new MT system (UM-BT)	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.

Primary Outcome Measures

Name	Time	Method
Change scores of Fugl-Meyer Assessment	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)	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	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)	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

Name	Time	Method
change scores of Barthel Index	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)	The Barthel Index is a validated tool designed to measure activities reflecting the daily living independence.
change scores of Motor Activity Log	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)	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 visual analogue scale (VAS) of EQ-5D-5L	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)	The VAS of EQ-5D-5L scores will be scored from 0 to 100, with a higher score indicating better overall current health.
change scores of Revised Nottingham Sensory Assessment	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)	The Revised Nottingham Sensory Assessment is a standardized measure with good reliability to assess sensory function in patients with stroke.
change scores of Box and Block Test	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)	The Box and Block Test is a tool with sound reliability and validity to evaluate hand dexterity of stroke patients.
change scores of Movement Imagery Questionnaire-Revised, Second Edition	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)	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 the health state of EQ-5D-5L	baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)	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.

Trial Locations

Locations (2)

Lo-Sheng Sanatorium and Hospital; 🇨🇳 Taoyuan City, Taoyuan, Taiwan

Taoyuan Chang Gung Memorial Hospital; 🇨🇳 Taoyuan City, Taiwan