MUSic Therapy In Complex Specialist Neurorehabilitation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-80
SponsorUniversity College, London

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Music Therapy

    Behavioral

    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.

  • Control Therapy

    Behavioral

    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.

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Music TherapyExperimental treatment 1 intervention
Group B: Control TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

FIM+FAM score post-intervention

Difference in FIM+FAM post-intervention scores between intervention groups at the 10 week follow up time point, with baseline score added as a covariate. Minimum: 30 Maximum: 210 Higher scores mean a better outcome.

Time frame
10 weeks
2

Northwick Park Nursing Dependency Scale (NWPDS) score post-intervention

Difference in NWPDS post-intervention scores between intervention groups at the 10 week follow up time point, with baseline score added as a covariate. Minimum: 0 Maximum: 100 Lower scores mean a better outcome.

Time frame
10 weeks
3

Barthel Activities of Daily Living score post-intervention

Difference in Barthel Activities of Daily Living post-intervention scores between intervention groups at the 10 week follow up time point, with baseline score added as a covariate. Minimum: 0 Maximum: 100 Higher scores mean a better outcome.

Time frame
10 weeks

Secondary outcomes

1

Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS) score post-intervention

Difference in HADS-A post-intervention scores between intervention groups at the 10 week follow up time point, with baseline score added as a covariate. Minimum: 0 Maximum: 21 Lower scores mean a better outcome.

Time frame
10 weeks
2

Depression Intensity Scale Circles (DISC) score post-intervention

Difference in DISC post-intervention scores between intervention groups at the 10 week follow up time point, with baseline score added as a covariate. Minimum: 0 Maximum: 5 Lower scores mean a better outcome.

Time frame
10 weeks
3

Sickness Impact Profile Social Interaction Subscale (SIPSIS) score post-intervention

Difference in SIPSIS post-intervention scores between intervention groups at the 10 week follow up time point, with baseline score added as a covariate. Minimum: 0 Maximum: 20 Higher scores mean a better outcome.

Time frame
10 weeks
4

Communication Outcomes After Stroke (COAST) Scale score post-intervention

Difference in COAST post-intervention scores between intervention groups at the 10 week follow up time point, with baseline score added as a covariate. Minimum: 0 Maximum: 54 Higher scores mean a better outcome.

Time frame
10 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University College, London

Lead sponsor

Nordoff and Robbins

Collaborator

University College London Hospitals

Collaborator