Clinical trial · Interventional
MUSic Therapy In Complex Specialist Neurorehabilitation
Pilot Study to Evaluate MUSic Therapy in Complex Specialist Neurorehabilitation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acquired Brain Injury | — | UNRESOLVED | — |
| Autoimmune Diseases | — | UNRESOLVED | — |
| Meningitis/Encephalitis | — | UNRESOLVED | — |
| Peripheral Nervous System Diseases | — | UNRESOLVED | — |
| Spinal Cord Injuries | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
| Subarachnoid Hemorrhage | — | UNRESOLVED | — |
| Traumatic Brain Injury | — | UNRESOLVED | — |
| Tumor, Brain | Brain Neoplasm | ALIAS |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control Therapy | Behavioral | — | UNRESOLVED |
| Music Therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Music Therapy
- description
- See Intervention section
- interventionNames
- Behavioral: Music Therapy
- type
- ACTIVE_COMPARATOR
- label
- Control Therapy
- description
- See Intervention section
- interventionNames
- Behavioral: Control Therapy
Primary outcomes (3)
- measure
- FIM+FAM score post-intervention
- timeFrame
- 10 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDTurner-Stokes L, Paul S, Williams H. Efficiency of specialist rehabilitation in reducing dependency and costs of continuing care for adults with complex acquired brain injuries. J Neurol Neurosurg Psychiatry. 2006 May;77(5):634-9. doi: 10.1136/jnnp.2005.073411. PMID 16614023
- BACKGROUNDTurner-Stokes L, Nyein K, Halliwell D. The Northwick Park Care Needs Assessment (NPCNA): a directly costable outcome measure in rehabilitation. Clin Rehabil. 1999 Jun;13(3):253-67. doi: 10.1191/026921599677787870. PMID 10392653
- BACKGROUNDAltenmuller E, Schlaug G. Apollo's gift: new aspects of neurologic music therapy. Prog Brain Res. 2015;217:237-52. doi: 10.1016/bs.pbr.2014.11.029. Epub 2015 Feb 11. PMID 25725918
- BACKGROUNDLe Perf G, Donguy AL, Thebault G. Nuanced effects of music interventions on rehabilitation outcomes after stroke: a systematic review. Top Stroke Rehabil. 2019 Sep;26(6):473-484. doi: 10.1080/10749357.2019.1623518. Epub 2019 Jun 6. PMID 31170034
- BACKGROUNDVik BMD, Skeie GO, Specht K. Neuroplastic Effects in Patients With Traumatic Brain Injury After Music-Supported Therapy. Front Hum Neurosci. 2019 Jun 25;13:177. doi: 10.3389/fnhum.2019.00177. eCollection 2019. PMID 31293405