Clinical trial NCT04813120: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cerebrovascular Disorders
Central Nervous System Diseases
Keywords: digital rehabilitation
cerebrovascular accident
mirror visual feedback
brain electrophysiology
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change scores of Fugl-Meyer Assessment
timeFrame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
measure: Change scores of Chedoke Arm and Hand Activity Inventory
timeFrame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
Secondary outcomes:
measure: change scores of Box and Block Test
timeFrame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
measure: change scores of Revised Nottingham Sensory Assessment
timeFrame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
measure: change scores of Movement Imagery Questionnaire-Revised, Second Edition
timeFrame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
measure: change scores of Barthel Index
timeFrame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
measure: change scores of Motor Activity Log
timeFrame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
measure: change scores of the health state of EQ-5D-5L
timeFrame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
measure: change scores of the visual analogue scale (VAS) of EQ-5D-5L
timeFrame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Lo-Sheng Sanatorium and Hospital
state: Taoyuan
city: Taoyuan City
country: Taiwan
facility: Taoyuan Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Occupational Therapy, College of Medicine, Chang Gung University
name: Yu-Wei Hsieh, PhD
role: PRINCIPAL_INVESTIGATOR
References: