Trial Title:
MUSic Therapy In Complex Specialist Neurorehabilitation
NCT ID:
NCT05777499
Condition:
Stroke
Subarachnoid Hemorrhage
Traumatic Brain Injury
Tumor, Brain
Autoimmune Diseases
Meningitis/Encephalitis
Acquired Brain Injury
Spinal Cord Injuries
Peripheral Nervous System Diseases
Conditions: Official terms:
Brain Neoplasms
Brain Injuries
Spinal Cord Injuries
Brain Injuries, Traumatic
Subarachnoid Hemorrhage
Meningitis
Nervous System Diseases
Encephalitis
Peripheral Nervous System Diseases
Autoimmune Diseases
Hemorrhage
Wounds and Injuries
Conditions: Keywords:
Neurological injury
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Parallel-armed randomised controlled trial
Primary purpose:
Treatment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Masking description:
Researchers and care providers measuring Barthel and NWPDS primary outcome measures, and
all secondary outcomes post-10 weeks intervention will be blinded to group allocation.
The only outcome measures to be obtained by individuals who are not blinded to
intervention group will be (i) post-intervention FIM+FAM, 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:
Intervention type:
Behavioral
Intervention name:
Music Therapy
Description:
Music Therapy will comprise individual and group sessions 20-45 minutes. Participants
usually have 1-2 individual sessions, and 1 group session/week. Group sessions include
2-6 participants. On average, participants receive an average 1 hour 30 minutes Music
Therapy/week, timetabled when they would not otherwise be undergoing any therapy
sessions. The Music Therapist will use the Nordoff Robbins approach and work flexibly as
a musician. Techniques include (but are not limited to) empathic listening, musically
matching, turn taking and sequencing, call and response. Sessions may also involve
songwriting, singing familiar songs, listening to, sharing and discussing music,
developing specific musical skills of interest to the participant, structured musical
games and activities, joint working with other members of the therapy team in sessions
focused on functional development and communication skills.
Arm group label:
Music Therapy
Intervention type:
Behavioral
Intervention name:
Control Therapy
Description:
Control Therapy sessions will be carried out by a member of the clinical team, matched in
duration and number to Music Therapy sessions as closely as possible. Participants will
usually have 1-2 individual sessions and 1 group session/week. Group sessions include 2-6
participants. The Control Therapy intervention will continue throughout participant's
rehabilitation program until participants have completed a total of 15 hours
intervention, which will usually take 10 weeks to complete. The content of sessions is
designed to reflect 'usual care' however control therapy sessions will not include access
to specific specialist equipment such as MOTOmed, 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 five domains: gaming, education, mindfulness, current affairs discussions,
and passive and dynamic stretching.
Arm group label:
Control Therapy
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, and/or 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 Measure+Functional Assessment Measure (FIM+FAM), 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 participant's 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 (FIM+FAM, 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 FIM+FAM, 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 and/or 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 FIM+FAM 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 (rando.la).
The majority of outcome measures will be obtained by individuals who are blinded to
intervention group, apart from (i) post-intervention FIM+FAM, 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 patient's 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 therapist's 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 space/pauses, invitations to change musical parameters
(e.g. 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 (e.g. 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, music's 'ripple effect', which enables the
impact of music therapy to extend beyond the music therapy room and referred clients
(e.g. 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 Therapist's flexibility in responding to clients' needs and preferences, e.g. 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, e.g. 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 participant's 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 (FIM+FAM, 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. FIM+FAM 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 participant's 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 16 years or above.
- Clinical diagnosis of a neurological injury involving the brain, spinal cord, and/or
peripheral nerves, sustained during the current hospital admission.
- Participant has complex rehabilitation needs warranting admission to a specialist
neurorehabilitation unit.
- Willing and able to provide written informed consent. If the participant is unable
to demonstrate sufficient mental capacity to provide informed consent, the
multidisciplinary team will liaise with the participant to identify a suitable
consultee to determine suitability to participate in the study in their best
interests.
Exclusion Criteria:
- Participant is medically unstable or excessively drowsy, and is unexpected to be
able to tolerate an intensive rehabilitation program.
- Participant is expected to be discharged from hospital before 10 weeks.
- Concurrent and/or recent involvement in other research that is likely to interfere
with the intervention within the last 3 months of study enrolment.
Gender:
All
Minimum age:
16 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University College Hospitals NHS Foundation Trust
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Orlando Swayne
Phone:
08451555000
Phone ext:
83904
Email:
o.swayne@nhs.net
Start date:
June 5, 2023
Completion date:
October 2025
Lead sponsor:
Agency:
University College, London
Agency class:
Other
Collaborator:
Agency:
Nordoff and Robbins
Agency class:
Other
Collaborator:
Agency:
University College London Hospitals
Agency class:
Other
Source:
University College, London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05777499
