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

NCT04813120 | Completed

• 1 other identifier: 202002234A3
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief Summary

The specific study aims will be:

1. 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. 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.

Conditions

Stroke; Cerebrovascular Disorders; Central Nervous System Diseases

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (7)

• change scores of Box and Block Test

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

• change scores of Revised Nottingham Sensory Assessment

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

• 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)

• change scores of Barthel Index

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

• change scores of Motor Activity Log

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

Study Arms (4)

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

EXPERIMENTAL

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.

Behavioral: 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)

EXPERIMENTAL

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.

Behavioral: 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)

EXPERIMENTAL

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.

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

Traditional MT using a mirror box

ACTIVE COMPARATOR

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.

Behavioral: Traditional MT using a mirror box

Interventions

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

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

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) 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.

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

Traditional MT using a mirror box 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.

Traditional MT using a mirror box

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (2)

Lo-Sheng Sanatorium and Hospital

Taoyuan, Taoyuan, 333, Taiwan

Location

Taoyuan Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders; Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yu-Wei Hsieh, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: March 24, 2021
• Study Start: August 1, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 21, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)