Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05399121
Status:
RECRUITING
Last Update Posted:
2023-08-31
First Post:
2022-05-16
Brief Title:
Stroke Patients Music Therapist Engagement and Patients Finger Movement During Music Therapeutic Interaction
Sponsor:
Reuth Rehabilitation Hospital
Organization:
Reuth Rehabilitation Hospital
Study Overview
Official Title:
Stroke Patients Music Therapist Engagement and Patients Finger Movement During Music Therapeutic Interaction - A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 therapists 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 patients engagement and improves their affected hand and finger movement
Objectives a To investigate real-time mechanisms and possible association between stroke patients engagement level music therapists engagement level and the patients 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 patients 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 patients and music therapists engagements levels and a MIDI-based assessment of the patients finger tapping movement during the session
Objectives a To investigate real-time mechanisms and possible association between stroke patients engagement level music therapists engagement level and the patients 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 patients 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 patients and music therapists engagements levels and a MIDI-based assessment of the patients 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 patients 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 therapists 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 patients engagement and improves their affected hand and finger movement
Objectives a To investigate real-time mechanisms and possible association between stroke patients engagement level music therapists engagement level and the patients 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 patients 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 n30 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 therapists 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 patients 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 patients MIDI data files will be exported for analysis after the session has been completed Finally supplementary video recordings of the patients 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 sessions content
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 patients 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 therapists 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 patients engagement and improves their affected hand and finger movement
Objectives a To investigate real-time mechanisms and possible association between stroke patients engagement level music therapists engagement level and the patients 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 patients 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 n30 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 therapists 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 patients 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 patients MIDI data files will be exported for analysis after the session has been completed Finally supplementary video recordings of the patients 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 sessions content
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None