Clinical trial NCT05399121: 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
Overall status: RECRUITING
Phase: NA
Conditions: Hemiparesis;Poststroke/CVA
Keywords: music therapy
Music Therapeutic Interaction
engagement
EEG
hyperscanning
finger tapping movement
neurorehabilitation
Lead sponsor: Reuth Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: University of Haifa
First posted: 2022-06-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each participant will be randomized into one of two groups.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Level of Patient Engagement during Baseline based on CEI Measurement
timeFrame: 1 session, 5 minutes
measure: The Level of Patient Engagement during Piano Learning Exercise based on CEI Measurement
timeFrame: 1 session, 5 minutes
measure: The Level of Patient Engagement during Free Improvisation Exercise based on CEI Measurement
timeFrame: 1 session, 5 minutes
measure: Patient's finger tapping movement during baseline
timeFrame: 1 session, 5 minutes
measure: Patient's finger tapping movement during Piano Learning Exercise
timeFrame: 1 session, 5 minutes
measure: Patient's finger tapping movement during Free Improvisation Exercise
timeFrame: 1 session, 5 minutes
measure: The Level of Therapist Engagement during Piano Learning Exercise based on CEI Measurement
timeFrame: 1 session, 5 minutes
measure: The Level of Therapist Engagement during Free Improvisation Exercise based on CEI Measurement
timeFrame: 1 session, 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Reuth Rehabilitation Hospital
Study officials:
affiliation: Reuth Rehabilitation Hospital
name: Avi Ohry, MD
role: PRINCIPAL_INVESTIGATOR
References: