Clinical trial NCT05011448: Correlation Between Music Therapist's and Stroke Patient's Engagement Levels and Patient's Fingers and Wrist Movement
Official title: Correlation Between EEG Based Assessment of Music Therapist and Stroke Patient's Engagement and Patient's Fingers and Wrist Movement During Music Therapeutic Interaction Versus Verbal Interaction - A Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemiparesis;Poststroke/CVA
Keywords: Music Therapy
Music Theraputic Interaction
Engagement
EEG
Fingers Movement
Wrist Movement
Lead sponsor: Reuth Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: University of Haifa
First posted: 2021-08-18
Enrollment: 4
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: Fingers and wrist functional impairments are common among stroke patients. The patient's engagement, their therapist's engagement, and the patient-therapist interaction during therapy, contribute significantly towards better outcomes in rehabilitation. Music therapeutic interaction between patient and music therapist, which involves active music-making, can enhance a stroke patient's engagement and improve fingers and wrist movement of the affected hand.

Study Objectives: 1. To assess the correlation between the therapist engagement's levels, patient engagement's levels, and patient's fingers and wrist movement. 2. To examine how the levels of patient and therapist engagement differ during music therapeutic interaction when compared with verbal interaction. 3. To determine if the changes to patients' fingers and wrist movement differ during a music therapeutic Interaction session when compared with a verbal interaction session.

Methods: This feasibility pilot study will include 10 patients, with right-sided hemiparesis who will be recruited 1-6 months following stroke. Each subject will participate in 2 sessions: verbal interaction session and music interactions session conducted both by the same qualified music therapist. For both sessions, each participant will be asked to perform three musical exercises with their right hand on an electric piano. During the Verbal Interaction session, participants will perform exercises alone, while the therapist only interacts with them verbally. During the second session, the Music Therapeutic Interaction session, participants will perform musical exercises while the therapist is interacting with them musically, using music therapy techniques. Measurement tools will include an EEG marker - the Cognitive Effort Index (CEI), for real-time measurement of the patient's and therapist's level of engagement; the HandTutorTM for evaluating real-time changes in a patient's fingers and wrist movement; and video recordings of the patient's hands while performing the musical exercises.

Detailed description: Background: Fingers and wrist functional impairments are common among stroke patients. The patient's engagement, their therapist's engagement, and the patient-therapist interaction during therapy, contribute significantly towards better outcomes in rehabilitation. Music therapeutic interaction between patient and music therapist, which involves active music making, can enhance a stroke patient's engagement and improve fingers and wrist movement of the affected hand.

Study Objectives:

1. To assess the correlation between the therapist engagement's levels, patient engagement's levels and patient's fingers and wrist movement.
2. To examine how the levels of patient and therapist engagement differ during music therapeutic interaction when compared with verbal interaction.
3. To determine if the changes to patients' fingers and wrist movement differ during a music therapeutic Interaction session when compared with a verbal interaction session.

Methods

Participants:

Post stroke rehabilitation patients with right hemiparesis (n=10), recruited 1-6 months following stroke from Reuth Rehabilitation hospital.

Recruitment process:

The research team will screen patients' records on a daily basis to identify potentially eligible participants. Eligible patients will be invited by the research coordinator to participate in the study. After obtaining informed consent the researcher will meet them for an intake.

Sample size:

Based on Reuth's electronic medical records, with the assumption that some of the eligible patients will not agree to participate, for this feasibility study a convenience sample of 10 patients will be recruited within two months. Outcome data will be utilized to inform a sample size calculation for the larger study.

Study design and procedures

This is an intervention study that compares Verbal Interaction to Music Therapeutic Interaction. Each subject will participate in both sessions and will act as their own control, enabling between and within subject comparisons. There will be a two day washout period between the sessions for each patient, to prevent carryover effects. To minimize the between and within subject variance, the sequence of both sessions, including the order of the three musical exercises within each session, will be the same for all study participants. Both sessions will be delivered by the same qualified music therapist with vast clinical experience working with stroke patients in a neurorehabilitation setting. 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) (Neurosky MindWave). Additionally, patients will be wearing a fingers and wrist movement monitoring device on their right affected hand, via the HandTutorTM (MediTouch, Ltd.). Within each session the music therapist's engagement level, the patient's engagement level, and the patient's real-time fingers and wrist movement will be measured.

Finally, video recordings of the patient's hands while performing the musical exercises during both interventions will be used to synchronize between the CEI and the HandTutorTM glove.

Eligibility criteria: Inclusion Criteria:

1. Age 55 and above.
2. Ability to understand and speak Hebrew.
3. First CVA (ischemic or hemorrhagic) with right side hemiparesis
4. Hand dominance: Right.
5. With sufficient autonomy in motor functions of upper limbs in order to use musical instruments.
6. Cognition: Mini-Mental State Examination \>24 or MoCA Test\>26.
7. No previous musical education.

Exclusion Criteria:

1. History of or current neurological or psychiatric disease.
2. Aphasia or amusia.

Primary outcomes:
measure: Patient's engagement
timeFrame: 2 sessions, 30-minutes each
measure: Therapist's engagement
timeFrame: 2 sessions, 30-minutes each
measure: Patient's fingers and wrist movement
timeFrame: 2 sessions, 30-minutes each
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Reuth Rehabilitation Hospital
Study officials:
affiliation: Reuth Rehabilitation Hospital, Tel-Aviv, Israel
name: Avi Ohry, M.D
role: PRINCIPAL_INVESTIGATOR
References: