NCT05777499 MUSic Therapy In Complex Specialist Neurorehabilitation
| NCT ID | NCT05777499 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College, London |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2023-06-05 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2023-06-05 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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
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.
Contact & Investigator
Sara Ajina
PRINCIPAL INVESTIGATOR
Honorary Consultant in Rehabilitation Medicine
Frequently Asked Questions
Who can join the NCT05777499 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 80 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05777499 currently recruiting?
Yes, NCT05777499 is actively recruiting participants. Contact the research team at sara.ajina@nhs.net for enrollment information.
Where is the NCT05777499 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05777499 clinical trial?
NCT05777499 is sponsored by University College, London. The principal investigator is Sara Ajina at Honorary Consultant in Rehabilitation Medicine. The trial plans to enroll 75 participants.
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