Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05777499
Status:
RECRUITING
Last Update Posted:
2023-03-21
First Post:
2023-03-08
Brief Title:
MUSic Therapy In Complex Specialist Neurorehabilitation
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
Pilot Study to Evaluate MUSic Therapy in Complex Specialist Neurorehabilitation
Status:
RECRUITING
Status Verified Date:
2024-10
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:
MUSICS
Brief Summary:
Aim Investigate whether patients undergoing specialist rehabilitation after complex neurological injury show different functional outcomes if music therapy is included in their rehabilitation program compared to usual care
Background Patients with complex needs following a brain spinal cord andor peripheral nerve injury often require a period of specialist neurorehabilitation This involves multiple therapy disciplines led by a Consultant in Rehabilitation Medicine Neurology or Neuropsychiatry Although music therapy is suggested to enhance neuroplasticity and recovery in patients with brain injury it is not routinely commissioned in clinical care due to a lack of supportive evidence
Hypothesis Patients undergoing music therapy in addition to complex specialist rehabilitation show better functional outcomes compared to usual care
Number of participants 75 aged 16-80 years Methods Patients undergo baseline assessments and are randomised to MUSIC or CONTROL Therapy Both arms receive 1-3 additional therapy sessions per week matched for duration and number total 15 hours After approximately 10-weeks intervention assessments are repeated All participants then have access to music therapy until they are discharged from Neurorehabilitation Unit NRU with additional qualitative data collection using semi-structured interviews field notes staff reports staff stress surveys and broader ecological observations
Duration for Participants From consent to discharge from NRU Primary Outcome Change in Functional Independence MeasureFunctional Assessment Measure FIMFAM Northwick Park Dependency Scale NWPDS and Barthel Activities of Daily Living pre and post 15 hours intervention
Secondary Outcome Change in quality of life Flourishing Scale psychological distress Hospital Anxiety and Depression Scale Depression Intensity Scale Circles social interaction Sickness Impact Profile Social Interaction Subscale well-being WHO Well-Being Index and communication Communication Outcomes After Stroke Scale pre and post 15 hours intervention Mean difference in well-being WHO Well-Being Index throughout the intervention period between music therapy and control therapy groups Mean difference in post-intervention pain and mood visual analogue scores between music therapy and control therapy groups
Background Patients with complex needs following a brain spinal cord andor peripheral nerve injury often require a period of specialist neurorehabilitation This involves multiple therapy disciplines led by a Consultant in Rehabilitation Medicine Neurology or Neuropsychiatry Although music therapy is suggested to enhance neuroplasticity and recovery in patients with brain injury it is not routinely commissioned in clinical care due to a lack of supportive evidence
Hypothesis Patients undergoing music therapy in addition to complex specialist rehabilitation show better functional outcomes compared to usual care
Number of participants 75 aged 16-80 years Methods Patients undergo baseline assessments and are randomised to MUSIC or CONTROL Therapy Both arms receive 1-3 additional therapy sessions per week matched for duration and number total 15 hours After approximately 10-weeks intervention assessments are repeated All participants then have access to music therapy until they are discharged from Neurorehabilitation Unit NRU with additional qualitative data collection using semi-structured interviews field notes staff reports staff stress surveys and broader ecological observations
Duration for Participants From consent to discharge from NRU Primary Outcome Change in Functional Independence MeasureFunctional Assessment Measure FIMFAM Northwick Park Dependency Scale NWPDS and Barthel Activities of Daily Living pre and post 15 hours intervention
Secondary Outcome Change in quality of life Flourishing Scale psychological distress Hospital Anxiety and Depression Scale Depression Intensity Scale Circles social interaction Sickness Impact Profile Social Interaction Subscale well-being WHO Well-Being Index and communication Communication Outcomes After Stroke Scale pre and post 15 hours intervention Mean difference in well-being WHO Well-Being Index throughout the intervention period between music therapy and control therapy groups Mean difference in post-intervention pain and mood visual analogue scores between music therapy and control therapy groups
Detailed Description:
The study will be conducted as a single centre researcher-blinded randomised parallel group trial comparing inclusion of 15 hours of music therapy to 15 hours of control therapy embedded in usual care and spread out over approximately 10 weeks of a level 1 in inpatient neurorehabilitation program
Participant demographics age gender diagnosis and date of neurological injury date of admission and discharge from NRU Patient Categorisation Tool Neurological Impairment Scale NIS on admission and concurrent medications will be recorded as trial data There will also be a record of participants therapy timetable to compare the total number of hours of therapy outside the intervention being evaluated in both intervention groups This information will be anonymised with participants having been allocated a coded identification number at the time of enrolment that will be used for all study data
Baseline data will include functional outcome measures FIMFAM NWPDS Barthel in addition to specific measures of quality of life well-being social interaction psychological distress pain and communication confidence questionnaires and visual analogue scales A trained therapist who is providing regular clinical input to the participant will complete FIMFAM and a nurse providing regular clinical care will complete the NWPDS and Barthel scores The Flourishing Scale Anxiety Subscale of the Hospital Anxiety and Depression Scale HADS Depression Intensity Scale Circles DISC Sickness Impact Profile Social Interaction Subscale SIPSIS adapted to inpatients by excluding four items irrelevant to individuals in hospital Communication Outcomes After Stroke COAST Scale and WHO Well-Being Index WHO-WBI will be completed with the participant by a designated Research Therapist If the participant has particularly severe communication andor cognitive impairment and cannot participate with the COAST questionnaire the 15-item carer version will be used The same version will be used for pre and post-intervention assessments
Participants will then be randomised to either Music or Control Therapy representing treatment as usual in addition to the usual intensive rehabilitation program with minimisation of between group differences in age gender diagnosis time since neurological injury and baseline level of function Both treatment arms will also be balanced for number and duration of intervention sessions to rule out an intervention effect of therapy time After 15 hours of intervention has been provided approximately 10 weeks the clinical research team will reassess the primary and secondary outcome measures with all assessments carried out within 1 week of completing the intervention Researchers measuring Barthel and NWPDS primary outcome measures and all secondary outcomes post-10 weeks intervention will be blinded to group allocation Researchers measuring FIMFAM post-10 weeks intervention will be unblinded
Throughout the 10-week intervention period participants will undergo additional fortnightly assessments of well being WHO-WBI with the assessor blinded to group Participants will also undertake weekly measures of mood and pain before and after a single intervention session using visual analogue scales These assessments will be conducted by the person carrying out the intervention and will therefore be unblinded
Randomisation and Blinding
Following baseline assessments stratified randomisation will be used The following variables will be included as they are considered strong prognostic indicators of outcome in order of importance Baseline level of function age diagnosis time since neurological injury and gender Equal allocation will be applied to both treatment arms A single member of the research team will create random allocation lists using online randomisation software randola
The majority of outcome measures will be obtained by individuals who are blinded to intervention group apart from i post-intervention FIMFAM which will be carried out by a clinical therapist providing regular clinical input to the participant and ii weekly pain and mood visual analogue scores which will be carried out by the individual providing the intervention All analyses will be carried out by individuals blinded to the experimental conditions
Intervention
For the intervention group the Music Therapist will work with participants in individual and group sessions 20-45 minutes duration Participants will usually have 1 or 2 individual sessions and 1 group session per week Group sessions will include between 2-6 participants On average participants will receive an average 1 hour 30 minutes Music Therapy per week timetabled when they would not otherwise be undergoing any therapy sessions
The Music Therapist will be working within the Nordoff Robbins approach to music therapy and will have completed a 2-year Masters course and will be registered with the Health and Care Professions Council The approach described as music-centred context specific and person-centred is used across a range of patient groups As a member of the inter-disciplinary team the Music Therapist will have full access to patient records and will seek to offer musical opportunities tailored to each patients needs via active creative engagement
During sessions the Music Therapist will work flexibly as a musician drawing on a range of musical resources and techniques to encourage patients active engagement in music making in ways that are considered likely to support their emotional social cognitive and physical rehabilitation Sessions will be tailored to the individual and largely improvisatory with the Music Therapist responding in the moment to the participant and vice versa although the therapists decision-making will also be informed by broader context about the patient and their engagement in previous sessions Techniques the Music Therapist can draw on in improvisation include but are not limited to empathic listening musically matching what the participant is offering setting up musical expectations and leaving expectant spacepauses invitations to change musical parameters eg speeding up and slowing down accompanying reinforcing and extending ideas that the participant offers turn taking and sequencing and call and response A music therapy session may also involve the following activities although they will usually be approached in an improvisatory rather than pre-structured way songwriting singing familiar songs listening to sharing and discussing music developing specific musical skills of interest to the participant eg learning an instrument working on vocal technique structured musical games and activities joint working with other members of the therapy team in sessions focussed on functional development and communication skills
Some aspects of the Nordoff Robbins approach will be limited by the nature of the randomised controlled trial For instance musics ripple effect which enables the impact of music therapy to extend beyond the music therapy room and referred clients eg to those who overhear music from sessions will be limited due to restrictions on who can be exposed to music therapy The trial will also to some extent restrict the Music Therapists flexibility in responding to clients needs and preferences eg they will be unable to offer bedside sessions or extend sessions beyond 45 minutes There may also be limitations due to COVID-19 Coronavirus disease 2019 infection control requirements eg social distancing and mask wearing
Control Therapy sessions will be carried out by a member of the clinical team and will be matched in duration and number to Music Therapy sessions as closely as possible Participants will usually have between 1-2 individual sessions and 1 group session per week Group sessions will include between 2-6 participants The Control Therapy intervention will continue throughout participants rehabilitation program until participants have completed a total of 15 hours intervention which will usually take 10 weeks to complete The content of the sessions is designed to reflect usual care however control therapy sessions will not include access to specific specialist equipment such as MOTOmed device-based movement therapy therabike or neuro-muscular electrical stimulation to ensure the control group does not get additional specialist intervention beyond usual care Content of control therapy sessions will therefore be restricted to the following domains gaming education mindfulness current affairs discussions and passive and dynamic stretching
Post-Intervention
The following assessments will be repeated after 15 hours of intervention has been completed at approximately 10 weeks Functional outcome measures FIMFAM NWPDS Barthel quality of life Flourishing Scale psychological distress HADS Anxiety subscale and DISCs well-being WHO-WBI social interaction SIPSIS and communication confidence COAST These questionnaires will be carried out while participants are still inpatients on the neurorehabilitation unit FIMFAM will be scored by a trained therapist providing regular clinical input to the participant Barthel and NWPDS will be scored by a nurse Other outcomes will be obtained by the Research Therapist Once all assessments have been carried out participants from both treatment arms will be given access to music therapy although this may be limited to group sessions At a convenient time between the end of the intervention and the participants discharge from NRU participants and their friends and family may also be invited to take part in an optional semi-structured interview about their experiences and observations around music therapy as part of additional qualitative data collection It is expected that there may be up to 10 interviews with patients and their visitors during a 6-month qualitative research data collection period
Participant demographics age gender diagnosis and date of neurological injury date of admission and discharge from NRU Patient Categorisation Tool Neurological Impairment Scale NIS on admission and concurrent medications will be recorded as trial data There will also be a record of participants therapy timetable to compare the total number of hours of therapy outside the intervention being evaluated in both intervention groups This information will be anonymised with participants having been allocated a coded identification number at the time of enrolment that will be used for all study data
Baseline data will include functional outcome measures FIMFAM NWPDS Barthel in addition to specific measures of quality of life well-being social interaction psychological distress pain and communication confidence questionnaires and visual analogue scales A trained therapist who is providing regular clinical input to the participant will complete FIMFAM and a nurse providing regular clinical care will complete the NWPDS and Barthel scores The Flourishing Scale Anxiety Subscale of the Hospital Anxiety and Depression Scale HADS Depression Intensity Scale Circles DISC Sickness Impact Profile Social Interaction Subscale SIPSIS adapted to inpatients by excluding four items irrelevant to individuals in hospital Communication Outcomes After Stroke COAST Scale and WHO Well-Being Index WHO-WBI will be completed with the participant by a designated Research Therapist If the participant has particularly severe communication andor cognitive impairment and cannot participate with the COAST questionnaire the 15-item carer version will be used The same version will be used for pre and post-intervention assessments
Participants will then be randomised to either Music or Control Therapy representing treatment as usual in addition to the usual intensive rehabilitation program with minimisation of between group differences in age gender diagnosis time since neurological injury and baseline level of function Both treatment arms will also be balanced for number and duration of intervention sessions to rule out an intervention effect of therapy time After 15 hours of intervention has been provided approximately 10 weeks the clinical research team will reassess the primary and secondary outcome measures with all assessments carried out within 1 week of completing the intervention Researchers measuring Barthel and NWPDS primary outcome measures and all secondary outcomes post-10 weeks intervention will be blinded to group allocation Researchers measuring FIMFAM post-10 weeks intervention will be unblinded
Throughout the 10-week intervention period participants will undergo additional fortnightly assessments of well being WHO-WBI with the assessor blinded to group Participants will also undertake weekly measures of mood and pain before and after a single intervention session using visual analogue scales These assessments will be conducted by the person carrying out the intervention and will therefore be unblinded
Randomisation and Blinding
Following baseline assessments stratified randomisation will be used The following variables will be included as they are considered strong prognostic indicators of outcome in order of importance Baseline level of function age diagnosis time since neurological injury and gender Equal allocation will be applied to both treatment arms A single member of the research team will create random allocation lists using online randomisation software randola
The majority of outcome measures will be obtained by individuals who are blinded to intervention group apart from i post-intervention FIMFAM which will be carried out by a clinical therapist providing regular clinical input to the participant and ii weekly pain and mood visual analogue scores which will be carried out by the individual providing the intervention All analyses will be carried out by individuals blinded to the experimental conditions
Intervention
For the intervention group the Music Therapist will work with participants in individual and group sessions 20-45 minutes duration Participants will usually have 1 or 2 individual sessions and 1 group session per week Group sessions will include between 2-6 participants On average participants will receive an average 1 hour 30 minutes Music Therapy per week timetabled when they would not otherwise be undergoing any therapy sessions
The Music Therapist will be working within the Nordoff Robbins approach to music therapy and will have completed a 2-year Masters course and will be registered with the Health and Care Professions Council The approach described as music-centred context specific and person-centred is used across a range of patient groups As a member of the inter-disciplinary team the Music Therapist will have full access to patient records and will seek to offer musical opportunities tailored to each patients needs via active creative engagement
During sessions the Music Therapist will work flexibly as a musician drawing on a range of musical resources and techniques to encourage patients active engagement in music making in ways that are considered likely to support their emotional social cognitive and physical rehabilitation Sessions will be tailored to the individual and largely improvisatory with the Music Therapist responding in the moment to the participant and vice versa although the therapists decision-making will also be informed by broader context about the patient and their engagement in previous sessions Techniques the Music Therapist can draw on in improvisation include but are not limited to empathic listening musically matching what the participant is offering setting up musical expectations and leaving expectant spacepauses invitations to change musical parameters eg speeding up and slowing down accompanying reinforcing and extending ideas that the participant offers turn taking and sequencing and call and response A music therapy session may also involve the following activities although they will usually be approached in an improvisatory rather than pre-structured way songwriting singing familiar songs listening to sharing and discussing music developing specific musical skills of interest to the participant eg learning an instrument working on vocal technique structured musical games and activities joint working with other members of the therapy team in sessions focussed on functional development and communication skills
Some aspects of the Nordoff Robbins approach will be limited by the nature of the randomised controlled trial For instance musics ripple effect which enables the impact of music therapy to extend beyond the music therapy room and referred clients eg to those who overhear music from sessions will be limited due to restrictions on who can be exposed to music therapy The trial will also to some extent restrict the Music Therapists flexibility in responding to clients needs and preferences eg they will be unable to offer bedside sessions or extend sessions beyond 45 minutes There may also be limitations due to COVID-19 Coronavirus disease 2019 infection control requirements eg social distancing and mask wearing
Control Therapy sessions will be carried out by a member of the clinical team and will be matched in duration and number to Music Therapy sessions as closely as possible Participants will usually have between 1-2 individual sessions and 1 group session per week Group sessions will include between 2-6 participants The Control Therapy intervention will continue throughout participants rehabilitation program until participants have completed a total of 15 hours intervention which will usually take 10 weeks to complete The content of the sessions is designed to reflect usual care however control therapy sessions will not include access to specific specialist equipment such as MOTOmed device-based movement therapy therabike or neuro-muscular electrical stimulation to ensure the control group does not get additional specialist intervention beyond usual care Content of control therapy sessions will therefore be restricted to the following domains gaming education mindfulness current affairs discussions and passive and dynamic stretching
Post-Intervention
The following assessments will be repeated after 15 hours of intervention has been completed at approximately 10 weeks Functional outcome measures FIMFAM NWPDS Barthel quality of life Flourishing Scale psychological distress HADS Anxiety subscale and DISCs well-being WHO-WBI social interaction SIPSIS and communication confidence COAST These questionnaires will be carried out while participants are still inpatients on the neurorehabilitation unit FIMFAM will be scored by a trained therapist providing regular clinical input to the participant Barthel and NWPDS will be scored by a nurse Other outcomes will be obtained by the Research Therapist Once all assessments have been carried out participants from both treatment arms will be given access to music therapy although this may be limited to group sessions At a convenient time between the end of the intervention and the participants discharge from NRU participants and their friends and family may also be invited to take part in an optional semi-structured interview about their experiences and observations around music therapy as part of additional qualitative data collection It is expected that there may be up to 10 interviews with patients and their visitors during a 6-month qualitative research data collection period
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