MUSic Therapy In Complex Specialist Neurorehabilitation
NCT05777499 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2024-10-23
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
Interventions
- BEHAVIORAL
-
Music Therapy
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.
- BEHAVIORAL
-
Control Therapy
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.
Sponsors & Collaborators
-
Nordoff and Robbins
collaborator UNKNOWN -
University College London Hospitals
collaborator OTHER -
University College, London
lead OTHER
Principal Investigators
-
Sara Ajina · Honorary Consultant in Rehabilitation Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-05
- Primary Completion
- 2025-06-30
- Completion
- 2025-10-31
Countries
- United Kingdom
Study Locations
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