Actively Recruiting

Phase Not Applicable
Age: 16Years - 80Years
All Genders
NCT05777499

MUSic Therapy In Complex Specialist Neurorehabilitation

Led by University College, London · Updated on 2024-10-23

75

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

Sponsors

U

University College, London

Lead Sponsor

N

Nordoff and Robbins

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

MUSic Therapy In Complex Specialist Neurorehabilitation

Who Can Participate

Age: 16Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 16 years or above
  • Clinical diagnosis of neurological injury involving brain, spinal cord, and/or peripheral nerves from current hospital admission
  • Complex rehabilitation needs requiring admission to a specialist neurorehabilitation unit
  • Willing and able to provide written informed consent, or has a suitable consultee if lacking capacity
Not Eligible

You will not qualify if you...

  • Medically unstable or excessively drowsy, unlikely to tolerate intensive rehabilitation
  • Expected hospital discharge before 10 weeks
  • Participation in other research interfering with this intervention within last 3 months

AI-Screening

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Trial Site Locations

Total: 1 location

1

University College Hospitals NHS Foundation Trust

London, United Kingdom

Actively Recruiting

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Research Team

S

Sara Ajina

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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