MUSic Therapy In Complex Specialist Neurorehabilitation

NCT05777499 | Recruiting

• 1 other identifier: 151803
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Subarachnoid Hemorrhage; Traumatic Brain Injury; Tumor, Brain; Autoimmune Diseases; Meningitis/Encephalitis; Acquired Brain Injury; Spinal Cord Injuries; Peripheral Nervous System Diseases

Keywords

Neurological injury

Outcome Measures

Primary Outcomes (3)

• 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.

  10 weeks

• 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.

  10 weeks

• 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.

  10 weeks

Secondary Outcomes (8)

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

  10 weeks

• Depression Intensity Scale Circles (DISC) score post-intervention

  10 weeks

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

  10 weeks

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

  10 weeks

• Flourishing Scale score post-intervention

  10 weeks

Study Arms (2)

Music Therapy

EXPERIMENTAL

See Intervention section

Behavioral: Music Therapy

Control Therapy

ACTIVE COMPARATOR

See Intervention section

Behavioral: Control Therapy

Interventions

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.

Music Therapy

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.

Control Therapy

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead
• Nordoff and Robbins: collaborator
• University College London Hospitals: collaborator

Study Sites (1)

University College Hospitals NHS Foundation Trust

London, United Kingdom

RECRUITING

Related Publications (5)

• Turner-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 BACKGROUND

• Turner-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 BACKGROUND

• Altenmuller 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 BACKGROUND

• Le 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 BACKGROUND

• Vik 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 BACKGROUND

MeSH Terms

Conditions

Stroke; Subarachnoid Hemorrhage; Brain Injuries, Traumatic; Brain Neoplasms; Autoimmune Diseases; Meningitis; Encephalitis; Brain Injuries; Spinal Cord Injuries; Peripheral Nervous System Diseases; Trauma, Nervous System

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Wounds and Injuries; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Immune System Diseases; Neuroinflammatory Diseases; Spinal Cord Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sara Ajina

  Honorary Consultant in Rehabilitation Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Ajina

CONTACT

08451555000; sara.ajina@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel-armed randomised controlled trial

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 21, 2023
• Study Start: June 5, 2023
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)