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

NCT ID: NCT04813120

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2024-07-31

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.

Conditions

Stroke; Cerebrovascular Disorders; Central Nervous System Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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)

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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)

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Traditional MT using a mirror box

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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 affected arm and hand. In this group, the patient's affected arm and hand inside the mirror box will not need to move.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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 that have influenced upper-limb usage or caused severe pain

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

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Wei Hsieh, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Lo-Sheng Sanatorium and Hospital

Taoyuan, Taoyuan, Taiwan

Taoyuan Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Countries

Taiwan

Other Identifiers

202002234A3

Identifier Type: -

Identifier Source: org_study_id