Hemiparesis;Poststroke/CVANCT05399121
Stroke Patients', Music Therapist' Engagement and Patients' Finger Movement During Music Therapeutic Interaction
A study testing Piano Learning then Free Improvisation and Free Improvisation then Piano Learning in people with Hemiparesis;Poststroke/CVA, run by Reuth Rehabilitation Hospital at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hemiparesis;Poststroke/CVA
- What is being tested?
- Piano Learning then Free Improvisation and Free Improvisation then Piano Learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2022to 30 Sep 2024
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who do not speak or understand Hebrew at a sufficient level.
- Patients with global aphasia
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Reuth Rehabilitation Hospital
Tel Aviv, 6902732
Avi Ohry, M.D, + 972-3-6383661, ohry@reuth.org.il
About this study
Official title: Stroke Patients', Music Therapist' Engagement and Patients' Finger Movement During Music Therapeutic Interaction - A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Hemiparesis;Poststroke/CVA
- Being tested
- Piano Learning then Free Improvisation, Free Improvisation then Piano Learning
- Keywords
- music therapy, Music Therapeutic Interaction, engagement, EEG, hyperscanning, finger tapping movement, neurorehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piano Learning then Free ImprovisationBehavioural
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).
Free Improvisation then Piano LearningBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Free Improvisation then Piano Learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 session, 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Oct 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2024 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant will be randomized into one of two groups.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
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, MD, Principal investigator, Reuth Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399121
- Sponsor's protocol ID
- 004-22-RRH
- Status last verified
- Aug 2023
- First submitted
- 16 May 2022
- Last updated
- 31 Aug 2023
- 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 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Patients', Music Therapist' Engagement and Patients' Finger Movement During Music Therapeutic Interaction - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05399121
- Acronym / sponsor ID
- 004-22-RRH
- Conditions
- Hemiparesis;Poststroke/CVA
- Keywords
- music therapy, Music Therapeutic Interaction, engagement, EEG, hyperscanning, finger tapping movement, neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Reuth Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- University of Haifa
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 1 Jun 2022 (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: 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant will be randomized into one of two groups.
| Arm | Type | Receives |
|---|---|---|
| Group A: Piano Learning then Free Improvisation | Active comparator | Behavioral: Piano Learning then Free ImprovisationThis arm (n=15) will first begin the intervention with a Piano Learning exercise followed by a Free Improvisation exercise. |
| Group B: Free Improvisation then Piano Learning | Active comparator | Behavioral: Free Improvisation then Piano LearningThis arm (n=15) will first begin the intervention with a Free Improvisation exercise followed by a Piano Learning exercise. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who do not speak or understand Hebrew at a sufficient level.
- Patients with global aphasia
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 |
|---|---|---|
| Piano Learning then Free ImprovisationDuring 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). | Behavioural | Group A: Piano Learning then Free Improvisation |
| Free Improvisation then Piano LearningDuring 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). | Behavioural | Group B: Free Improvisation then Piano Learning |
Primary outcome
The Level of Patient Engagement during Baseline based on CEI Measurement
Time frame: 1 session, 5 minutes
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
Time frame: 1 session, 5 minutes
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
Time frame: 1 session, 5 minutes
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
Time frame: 1 session, 5 minutes
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
Time frame: 1 session, 5 minutes
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
Time frame: 1 session, 5 minutes
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
Time frame: 1 session, 5 minutes
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
Time frame: 1 session, 5 minutes
As described in Patient Engagement, however, Therapist Engagement will not be measured during baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- 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, MD principal investigator
Reuth Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piano Learning then Free Improvisation and Free Improvisation then Piano Learning 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 6 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: status not confirmed, as of the sponsor's last update on 31 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Avi Ohry, MD (+972-3-6383661, ohry@reuth.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Level of Patient Engagement during Baseline based on CEI Measurement (time frame: 1 session, 5 minutes). The study lists 8 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 31 Aug 2023.