Hemiparesis;Poststroke/CVANCT05011448
Correlation Between Music Therapist's and Stroke Patient's Engagement Levels and Patient's Fingers and Wrist Movement
A study testing Music Therapeutic Interaction and Verbal Interaction in people with Hemiparesis;Poststroke/CVA, run by Reuth Rehabilitation Hospital at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hemiparesis;Poststroke/CVA
- What is being tested?
- Music Therapeutic Interaction and Verbal Interaction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jul 2021to 9 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55 and above.
- Ability to understand and speak Hebrew.
- First CVA (ischemic or hemorrhagic) with right side hemiparesis
- Hand dominance: Right.
- With sufficient autonomy in motor functions of upper limbs in order to use musical instruments.
- Cognition: Mini-Mental State Examination >24 or MoCA Test>26.
- No previous musical education.
Who cannot join
- History of or current neurological or psychiatric disease.
- Aphasia or amusia.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- To assess the correlation between the therapist engagement's levels, patient engagement's levels and patient's fingers and wrist movement.
- To examine how the levels of patient and therapist engagement differ during music therapeutic interaction when compared with verbal interaction.
- 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.
- Conditions
- Hemiparesis;Poststroke/CVA
- Being tested
- Music Therapeutic Interaction and Verbal Interaction
- Keywords
- Music Therapy, Music Theraputic Interaction, Engagement, EEG, Fingers Movement, Wrist Movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Therapeutic Interaction and Verbal InteractionOther
In both sessions (the Verbal Interaction and the Music Therapeutic Interaction) participants will be asked to perform three piano playing exercises in a fixed order: (1) playing a musical scale, (2) playing a short excerpt from a familiar song, and (3) free improvisation. Both sessions will also include a protocol of verbal instructions given by the therapist before each exercise. In session A ('Verbal Interaction') participants will perform these exercises alone while the therapist is only interacting with them verbally (asking them questions, commenting regarding their performance etc.). In session B ('Music Therapeutic Interaction') participants will perform these exercises while the therapist is interacting with them musically, using various music therapy techniques that are matched and attuned to each patient's playing dynamics and style. This is to reflect the dynamics of the music therapeutic interaction as it occurs in the "real world" of music therapy practice.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study with two interventions | Other | Single arm where each participant will undergo two interventions in the following order: Verbal Interaction and Music Therapeutic Interaction. Both interactions will be conducted by the same music therapist. Receives: Other: Music Therapeutic Interaction and Verbal Interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's engagement
Cognitive Effort Index (CEI) (Neurosky MindWave) - 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 conditions the patient and the therapist will not have sight of the CEI monitor.
Measured: 2 sessions, 30-minutes each
Therapist's engagement
As described in the 'Patient's engagement' section
Measured: 2 sessions, 30-minutes each
Patient's fingers and wrist movement
HandTutorTM (MediTouch, Ltd.) - Will be used for real-time measuring of a patient's fingers and wrist movement. It includes an ergonomic glove with sensors which enables the patient's fingers and wrist movement to be monitored on a computer screen. This glove provides continuous feedback on range, speed and quality of the movement during the session. In both sessions the patient will be wearing one glove on his right affected hand. Prior to each exercise, there will be a baseline evaluation of the patient's fingers and wrist's active range of motion. These values will be the basis for the comparison of changes in patients' fingers and wrist range of motion during each of the exercises.
Measured: 2 sessions, 30-minutes each
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start15 Jul 2021
- Primary completion9 Jan 2022
- Study completion9 Jan 2022
Why it stopped: During the trial, feasibility testing indicated early on that major amendments would be needed so the decision was made to stop the pilot after collecting data on 4 participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparesis;Poststroke/CVAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reuth Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Haifa
- Responsible party
- Principal investigator, Avi Ohry, Reuth Rehabilitation Hospital
- Investigators
- Avi Ohry, M.D, Principal investigator, Reuth Rehabilitation Hospital, Tel-Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011448
- Sponsor's protocol ID
- 0010-21-RRH
- Status last verified
- Jan 2022
- First submitted
- 16 Aug 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05011448
- Acronym / sponsor ID
- 0010-21-RRH
- Conditions
- Hemiparesis;Poststroke/CVA
- Keywords
- Music Therapy, Music Theraputic Interaction, Engagement, EEG, Fingers Movement, Wrist Movement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: During the trial, feasibility testing indicated early on that major amendments would be needed so the decision was made to stop the pilot after collecting data on 4 participants.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Reuth Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- University of Haifa
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 9 Jan 2022 (actual)
- Study completion
- 9 Jan 2022 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the correlation between the therapist engagement's levels, patient engagement's levels and patient's fingers and wrist movement.
- To examine how the levels of patient and therapist engagement differ during music therapeutic interaction when compared with verbal interaction.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study with two interventions | Other | Other: Music Therapeutic Interaction and Verbal InteractionSingle arm where each participant will undergo two interventions in the following order: Verbal Interaction and Music Therapeutic Interaction. Both interactions will be conducted by the same music therapist. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 55 and above.
- Ability to understand and speak Hebrew.
- First CVA (ischemic or hemorrhagic) with right side hemiparesis
- Hand dominance: Right.
- With sufficient autonomy in motor functions of upper limbs in order to use musical instruments.
Key exclusion criteria (2 listed)
- History of or current neurological or psychiatric disease.
- Aphasia or amusia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Therapeutic Interaction and Verbal InteractionIn both sessions (the Verbal Interaction and the Music Therapeutic Interaction) participants will be asked to perform three piano playing exercises in a fixed order: (1) playing a musical scale, (2) playing a short excerpt from a familiar song, and (3) free improvisation. Both sessions will also include a protocol of verbal instructions given by the therapist before each exercise. In session A ('Verbal Interaction') participants will perform these exercises alone while the therapist is only interacting with them verbally (asking them questions, commenting regarding their performance etc.). In session B ('Music Therapeutic Interaction') participants will perform these exercises while the therapist is interacting with them musically, using various music therapy techniques that are matched and attuned to each patient's playing dynamics and style. This is to reflect the dynamics of the music therapeutic interaction as it occurs in the "real world" of music therapy practice. | Other | Single arm study with two interventions |
Primary outcome
Patient's engagement
Time frame: 2 sessions, 30-minutes each
Cognitive Effort Index (CEI) (Neurosky MindWave) - 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 conditions the patient and the therapist will not have sight of the CEI monitor.
Therapist's engagement
Time frame: 2 sessions, 30-minutes each
As described in the 'Patient's engagement' section
Patient's fingers and wrist movement
Time frame: 2 sessions, 30-minutes each
HandTutorTM (MediTouch, Ltd.) - Will be used for real-time measuring of a patient's fingers and wrist movement. It includes an ergonomic glove with sensors which enables the patient's fingers and wrist movement to be monitored on a computer screen. This glove provides continuous feedback on range, speed and quality of the movement during the session. In both sessions the patient will be wearing one glove on his right affected hand. Prior to each exercise, there will be a baseline evaluation of the patient's fingers and wrist's active range of motion. These values will be the basis for the comparison of changes in patients' fingers and wrist range of motion during each of the exercises.
Results and safety
The study was stopped early (reason given: During the trial, feasibility testing indicated early on that major amendments would be needed so the decision was made to stop the pilot after collecting data on 4 participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avi Ohry, M.D principal investigator
Reuth Rehabilitation Hospital, Tel-Aviv, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapeutic Interaction and Verbal Interaction in people with Hemiparesis;Poststroke/CVA, run by Reuth Rehabilitation Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: During the trial, feasibility testing indicated early on that major amendments would be needed so the decision was made to stop the pilot after collecting data on 4 participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's engagement (time frame: 2 sessions, 30-minutes each). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.