search
Back to results

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

Primary Purpose

Hemiparesis;Poststroke/CVA

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Piano Learning then Free Improvisation
Free Improvisation then Piano Learning
Sponsored by
Reuth Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiparesis;Poststroke/CVA focused on measuring music therapy, Music Therapeutic Interaction, engagement, EEG, hyperscanning, finger tapping movement, neurorehabilitation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients after unilateral ischemic or hemorrhagic stroke with right-side hemiparesis (left hemisphere stroke)
  2. Men and women age above 18 years old.
  3. Right-handed patients.
  4. 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).
  5. Patients able to understand, agree, and sign an Informed Consent Form.
  6. Patients with no previous formal piano playing education.

Exclusion Criteria:

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

Sites / Locations

  • Reuth Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A: Piano Learning then Free Improvisation

Group B: Free Improvisation then Piano Learning

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 16, 2022
Last Updated
August 29, 2023
Sponsor
Reuth Rehabilitation Hospital
Collaborators
University of Haifa
search

1. Study Identification

Unique Protocol Identification Number
NCT05399121
Brief Title
Stroke Patients', Music Therapist' Engagement and Patients' Finger Movement During Music Therapeutic Interaction
Official Title
Stroke Patients', Music Therapist' Engagement and Patients' Finger Movement During Music Therapeutic Interaction - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Reuth Rehabilitation Hospital
Collaborators
University of Haifa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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: Participants The study will include post-stroke rehabilitation patients with right hemiparesis (n=30), recruited from Reuth Rehabilitation Hospital 1-12 months following the stroke event. The recruitment process is as follows: The research team will screen patients' records on a daily basis to identify potentially eligible participants. Eligible patients will be invited by the researcher to participate in the study. After obtaining informed consent the researcher will meet them for the intervention. Study Design and Procedures This is a two-arm, randomized controlled trial (RCT) in which participants will be randomly assigned to one of two groups. In each group, participants will perform the same two piano exercises with the music therapist, but the order of the exercises will be reversed for each group. In both groups, the musical exercises will be carried out in a single session. Patients' and therapist's engagement levels and patients' finger-tapping movement scores will be measured during both exercises. Patients' engagement level and finger tapping movement scores will also be assessed at baseline (at the beginning of the session). All sessions will be delivered by the same music therapist. During both sessions, the therapist and the patient will each be wearing single channel EEG devices to monitor engagement, via the Cognitive Effort Index (CEI). Additionally, patient's finger tapping movement features of their right affected hand (velocity and regularity) will be collected via Cubase recording software while they perform both musical exercises on a MIDI keyboard with the therapist, as well as at baseline (where they play alone). The patient's MIDI data files will be exported for analysis after the session has been completed. Finally, supplementary video recordings of the patient's hands while performing the musical exercises during both exercises will be synchronized with the CEI and the MIDI and audio recording data. The video and audio data from the video camera will be used by the research team to keep track of the session's content.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis;Poststroke/CVA
Keywords
music therapy, Music Therapeutic Interaction, engagement, EEG, hyperscanning, finger tapping movement, neurorehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each participant will be randomized into one of two groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Piano Learning then Free Improvisation
Arm Type
Active Comparator
Arm Description
This arm (n=15) will first begin the intervention with a Piano Learning exercise followed by a Free Improvisation exercise.
Arm Title
Group B: Free Improvisation then Piano Learning
Arm Type
Active Comparator
Arm Description
This arm (n=15) will first begin the intervention with a Free Improvisation exercise followed by a Piano Learning exercise.
Intervention Type
Behavioral
Intervention Name(s)
Piano Learning then Free Improvisation
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Free Improvisation then Piano Learning
Intervention Description
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).
Primary Outcome Measure Information:
Title
The Level of Patient Engagement during Baseline based on CEI Measurement
Description
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.
Time Frame
1 session, 5 minutes
Title
The Level of Patient Engagement during Piano Learning Exercise based on CEI Measurement
Description
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.
Time Frame
1 session, 5 minutes
Title
The Level of Patient Engagement during Free Improvisation Exercise based on CEI Measurement
Description
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.
Time Frame
1 session, 5 minutes
Title
Patient's finger tapping movement during baseline
Description
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.
Time Frame
1 session, 5 minutes
Title
Patient's finger tapping movement during Piano Learning Exercise
Description
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.
Time Frame
1 session, 5 minutes
Title
Patient's finger tapping movement during Free Improvisation Exercise
Description
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.
Time Frame
1 session, 5 minutes
Title
The Level of Therapist Engagement during Piano Learning Exercise based on CEI Measurement
Description
As described in Patient Engagement, however, Therapist Engagement will not be measured during baseline.
Time Frame
1 session, 5 minutes
Title
The Level of Therapist Engagement during Free Improvisation Exercise based on CEI Measurement
Description
As described in Patient Engagement, however, Therapist Engagement will not be measured during baseline.
Time Frame
1 session, 5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patients who do not speak or understand Hebrew at a sufficient level. Patients with global aphasia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avi Ohry, MD
Phone
+972-3-6383661
Email
ohry@reuth.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Franklin Savion, M.A.
Phone
+972-50-5429009
Email
saviondana@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avi Ohry, MD
Organizational Affiliation
Reuth Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reuth Rehabilitation Hospital
City
Tel Aviv
ZIP/Postal Code
6902732
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avi Ohry, M.D
Phone
+ 972-3-6383661
Email
ohry@reuth.org.il

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs