Pilot Study to Evaluate MUSic Therapy in Complex Specialist Neurorehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- FIM+FAM score post-intervention
研究概览
简要总结
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.
详细描述
The study will be conducted as a single centre, researcher-blinded, randomised parallel group trial comparing inclusion of 15 hours of music therapy to 15 hours of control therapy, embedded in usual care and spread out over approximately 10 weeks of a level 1 in inpatient neurorehabilitation program.
Participant demographics (age, gender), diagnosis and date of neurological injury, date of admission and discharge from NRU, Patient Categorisation Tool, Neurological Impairment Scale (NIS) on admission, and concurrent medications will be recorded as trial data. There will also be a record of participant's therapy timetable, to compare the total number of hours of therapy (outside the intervention being evaluated) in both intervention groups. This information will be anonymised, with participants having been allocated a coded identification number at the time of enrolment that will be used for all study data.
Baseline data will include functional outcome measures (FIM+FAM, NWPDS, Barthel) in addition to specific measures of quality of life, well-being, social interaction, psychological distress, pain, and communication confidence (questionnaires and visual analogue scales). A trained therapist who is providing regular clinical input to the participant will complete FIM+FAM, and a nurse providing regular clinical care will complete the NWPDS and Barthel scores. The Flourishing Scale, Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS), Depression Intensity Scale Circles (DISC), Sickness Impact Profile Social Interaction Subscale (SIPSIS, adapted to inpatients by excluding four items irrelevant to individuals in hospital), Communication Outcomes After Stroke (COAST) Scale, and WHO Well-Being Index (WHO-WBI) will be completed with the participant by a designated Research Therapist. If the participant has particularly severe communication and/or cognitive impairment and cannot participate with the COAST questionnaire, the 15-item carer version will be used. The same version will be used for pre and post-intervention assessments.
Participants will then be randomised to either Music or Control Therapy (representing treatment as usual) in addition to the usual intensive rehabilitation program, with minimisation of between group differences in age, gender, diagnosis, time since neurological injury and baseline level of function. Both treatment arms will also be balanced for number and duration of intervention sessions to rule out an intervention effect of therapy time. After 15 hours of intervention has been provided (approximately 10 weeks), the clinical research team will reassess the primary and secondary outcome measures, with all assessments carried out within 1 week of completing the intervention. Researchers measuring Barthel and NWPDS primary outcome measures, and all secondary outcomes post-10 weeks intervention will be blinded to group allocation. Researchers measuring FIM+FAM post-10 weeks intervention will be unblinded.
Throughout the 10-week intervention period, participants will undergo additional fortnightly assessments of well being (WHO-WBI), with the assessor blinded to group. Participants will also undertake weekly measures of mood and pain before and after a single intervention session, using visual analogue scales. These assessments will be conducted by the person carrying out the intervention, and will therefore be unblinded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Music Therapy
See Intervention section
干预措施: Music Therapy (Behavioral)
Control Therapy
See Intervention section
干预措施: Control Therapy (Behavioral)
结局指标
主要结局
FIM+FAM score post-intervention
时间窗: 10 weeks
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.
Northwick Park Nursing Dependency Scale (NWPDS) score post-intervention
时间窗: 10 weeks
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.
Barthel Activities of Daily Living score post-intervention
时间窗: 10 weeks
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.
次要结局
- 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)
- Mean WHO-WBI throughout the intervention period(0 - 10 weeks)
- Mean post-intervention visual analogue score (VAS) for pain(0 - 10 weeks)
- Mean post-intervention visual analogue score (VAS) for mood(0 - 10 weeks)