Ignite Creation Date:
2024-05-06 @ 4:32 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05011448
Status:
TERMINATED
Last Update Posted:
2022-01-26
First Post:
2021-08-16
Brief Title:
Correlation Between Music Therapists and Stroke Patients Engagement Levels and Patients Fingers and Wrist Movement
Sponsor:
Reuth Rehabilitation Hospital
Organization:
Reuth Rehabilitation Hospital
Study Overview
Official Title:
Correlation Between EEG Based Assessment of Music Therapist and Stroke Patients Engagement and Patients Fingers and Wrist Movement During Music Therapeutic Interaction Versus Verbal Interaction - A Pilot and Feasibility Study
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Fingers and wrist functional impairments are common among stroke patients The patients engagement their therapists 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 patients engagement and improve fingers and wrist movement of the affected hand
Study Objectives 1 To assess the correlation between the therapist engagements levels patient engagements levels and patients 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 patients and therapists level of engagement the HandTutorTM for evaluating real-time changes in a patients fingers and wrist movement and video recordings of the patients hands while performing the musical exercises
Study Objectives 1 To assess the correlation between the therapist engagements levels patient engagements levels and patients 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 patients and therapists level of engagement the HandTutorTM for evaluating real-time changes in a patients fingers and wrist movement and video recordings of the patients hands while performing the musical exercises
Detailed Description:
Background Fingers and wrist functional impairments are common among stroke patients The patients engagement their therapists 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 patients engagement and improve fingers and wrist movement of the affected hand
Study Objectives
1 To assess the correlation between the therapist engagements levels patient engagements levels and patients 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 n10 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 Reuths 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 therapists engagement level the patients engagement level and the patients real-time fingers and wrist movement will be measured
Finally video recordings of the patients hands while performing the musical exercises during both interventions will be used to synchronize between the CEI and the HandTutorTM glove
Study Objectives
1 To assess the correlation between the therapist engagements levels patient engagements levels and patients 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 n10 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 Reuths 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 therapists engagement level the patients engagement level and the patients real-time fingers and wrist movement will be measured
Finally video recordings of the patients hands while performing the musical exercises during both interventions will be used to synchronize between the CEI and the HandTutorTM glove
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