Stroke Patients', Music Therapist' Engagement and Patients' Finger Movement During Music Therapeutic Interaction

NCT05399121 | Unknown

• 1 other identifier: 004-22-RRH
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Hand functional impairments are common among stroke patients. Rehabilitation therapies increase the possibility of functional recovery. Stroke patients' engagement and effort to work toward achieving rehabilitation goals is of major significance. Neurologically, patient's engagement is being reflected in their brain activity through high levels of sustained attention while performing therapy exercises. Therefore, greater engagement might lead to better sustained attention. Nevertheless, their therapist's engagement, the type of exercise used and the quality of patient-therapist interaction play a significant role in enhancing patients' engagement. Music therapeutic interaction between stroke patient and music therapist, which involves active music making, enhances patient's engagement and improves their affected hand and finger movement. Objectives: (a) To investigate real-time mechanisms and possible association between: stroke patient's engagement level, music therapist's engagement level and the patient's real-time finger tapping movement of his affected hand. This will be assessed during a Piano Learning exercise versus a Free Improvisation exercise, while the music therapist is musically interacting with the patient on the piano during both exercises. (b) To assess patient's engagement level and real-time finger tapping movement during both exercises when compared to their scores at baseline (when playing alone). Methods: This study, conducted in Reuth Rehabilitation Hospital, Israel, will include 30 right-handed stroke patients, with right impaired hand, 1-12 months following stroke. This is a two-arm, randomized controlled trial (RCT) in which the participants will be randomly assigned to one of two groups. In each group participants will perform the same two exercises with the therapist, but the order of the exercises will be reversed within each group. This will be carried out in a single session. Measurement tools will include an EEG marker - The Cognitive Effort Index (CEI) used for real-time measuring patient's and music therapist's engagement's levels, and a MIDI-based assessment of the patient's finger tapping movement during the session.

Conditions

Hemiparesis;Poststroke/CVA

Keywords

music therapy; Music Therapeutic Interaction; engagement; EEG; hyperscanning; finger tapping movement; neurorehabilitation

Outcome Measures

Primary Outcomes (8)

• The Level of Patient Engagement during Baseline based on CEI Measurement

  Cognitive Effort Index (CEI) - An easy to use EEG marker for attention which provides a real-time measurement of the patient's and therapist's engagements' levels throughout the session. The CEI data is sampled using a dry electrodes system, with one frontal electrode and one reference electrode on the earlobe. The sampled data is transferred through a wireless connection to a computer, where the data is processed and the CEI marker is generated every 10 seconds and presented by the CEI monitor. The CEI level of engagement appears within the scale of 0-1. During both sessions the patient will not see the CEI monitor.

  1 session, 5 minutes

• The Level of Patient Engagement during Piano Learning Exercise based on CEI Measurement

  Cognitive Effort Index (CEI) - An easy to use EEG marker for attention which provides a real-time measurement of the patient's and therapist's engagements' levels throughout the session. The CEI data is sampled using a dry electrodes system, with one frontal electrode and one reference electrode on the earlobe. The sampled data is transferred through a wireless connection to a computer, where the data is processed and the CEI marker is generated every 10 seconds and presented by the CEI monitor. The CEI level of engagement appears within the scale of 0-1. During both sessions the patient will not see the CEI monitor.

  1 session, 5 minutes

• The Level of Patient Engagement during Free Improvisation Exercise based on CEI Measurement

  Cognitive Effort Index (CEI) - An easy to use EEG marker for attention which provides a real-time measurement of the patient's and therapist's engagements' levels throughout the session. The CEI data is sampled using a dry electrodes system, with one frontal electrode and one reference electrode on the earlobe. The sampled data is transferred through a wireless connection to a computer, where the data is processed and the CEI marker is generated every 10 seconds and presented by the CEI monitor. The CEI level of engagement appears within the scale of 0-1. During both sessions the patient will not see the CEI monitor.

  1 session, 5 minutes

• Patient's finger tapping movement during baseline

  The patient's finger tapping movement data (velocity and regularity) will be collected via Cubase recording software while performing both musical exercises on a MIDI keyboard, as well as at baseline (where they play alone). The patient's MIDI data files will be exported for analysis after sessions have been completed.

  1 session, 5 minutes

• Patient's finger tapping movement during Piano Learning Exercise

  The patient's finger tapping movement data (velocity and regularity) will be collected via Cubase recording software while performing both musical exercises on a MIDI keyboard, as well as at baseline (where they play alone). The patient's MIDI data files will be exported for analysis after sessions have been completed.

  1 session, 5 minutes

• Patient's finger tapping movement during Free Improvisation Exercise

  The patient's finger tapping movement data (velocity and regularity) will be collected via Cubase recording software while performing both musical exercises on a MIDI keyboard, as well as at baseline (where they play alone). The patient's MIDI data files will be exported for analysis after sessions have been completed.

  1 session, 5 minutes

• The Level of Therapist Engagement during Piano Learning Exercise based on CEI Measurement

  As described in Patient Engagement, however, Therapist Engagement will not be measured during baseline.

  1 session, 5 minutes

• The Level of Therapist Engagement during Free Improvisation Exercise based on CEI Measurement

  As described in Patient Engagement, however, Therapist Engagement will not be measured during baseline.

  1 session, 5 minutes

Study Arms (2)

Group A: Piano Learning then Free Improvisation

ACTIVE COMPARATOR

This arm (n=15) will first begin the intervention with a Piano Learning exercise followed by a Free Improvisation exercise.

Behavioral: Piano Learning then Free Improvisation

Group B: Free Improvisation then Piano Learning

ACTIVE COMPARATOR

This arm (n=15) will first begin the intervention with a Free Improvisation exercise followed by a Piano Learning exercise.

Behavioral: Free Improvisation then Piano Learning

Interventions

Piano Learning then Free Improvisation BEHAVIORAL

During all 15 sessions (one session per patient) all patients will be asked to perform two piano playing exercises: Exercise 1 - Piano Learning exercise - The music therapist will guide the patient to use separate finger movement and to play a brief extract from a familiar song. The therapist guiding techniques may include (but not restricted to) demonstrating to the patient which keys to press (turn- taking), playing the same notes with them in synchronization, or harmonizing the patient's playing. The patient will then be asked to perform exercise 2. Exercise 2: Free Improvisation exercise -The patient will be instructed to use separate finger movement while playing freely on the piano while the therapist musically. The therapist will use various MT accompaniment techniques. Both exercises will be performed for the same amount of time (5 minutes each).

Group A: Piano Learning then Free Improvisation

Free Improvisation then Piano Learning BEHAVIORAL

During all 15 sessions (one session per patient) all patients will be asked to perform two piano playing exercises: Exercise 1: Free Improvisation exercise -The patient will be instructed to use separate finger movement while playing freely on the piano while the therapist musically interacts with them. The therapist will use various MT accompaniment techniques. The patient will then be asked to perform exercise 2. Exercise 2 - Piano Learning exercise - The music therapist will guide the patient to use separate finger movement and to play a brief extract from a familiar song. The therapist guiding techniques may include (but not restricted to) demonstrating to the patient which keys to press (turn- taking), playing the same notes with them in synchronization, or harmonizing the patient's playing. Both exercises will be performed for the same amount of time (5 minutes each).

Group B: Free Improvisation then Piano Learning

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients after unilateral ischemic or hemorrhagic stroke with right-side hemiparesis (left hemisphere stroke)
• Men and women age above 18 years old.
• Right-handed patients.
• Patients with sufficient autonomy in motor functions of the affected upper limb - Manual Muscle Testing (MMT) of the upper limb - Grades between 3-/5 and 4+/5 (inclusive) in at least 3 out of 5 muscle groups of the affected upper limb (shoulder, elbow, forearm, wrist, and fingers).
• Patients able to understand, agree, and sign an Informed Consent Form.
• Patients with no previous formal piano playing education.

You may not qualify if:

• Patients who do not speak or understand Hebrew at a sufficient level.
• Patients with global aphasia

Sponsors & Collaborators

• Reuth Rehabilitation Hospital: lead
• University of Haifa: collaborator

Study Sites (1)

Reuth Rehabilitation Hospital

Tel Aviv, 6902732, Israel

RECRUITING

Study Officials

• Avi Ohry, MD

  Reuth Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Avi Ohry, MD

CONTACT

+972-3-6383661; ohry@reuth.org.il

Dana Franklin Savion, M.A.

CONTACT

+972-50-5429009; saviondana@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Each participant will be randomized into one of two groups.

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 1, 2022
• Study Start: October 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)