An Investigation Into Music Therapy for Upper Limb Rehabilitation in Stroke Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
Impairment of arm function is more common than lower limb impairment in stroke patients and is also more resistant to treatment. Several clinical trials with stroke patients have produced statistically significant gains in upper limb function when using instrumental playing and treatments where rhythm supports the priming and timing of movements. Based on the positive results from controlled and non-controlled trials, the Cochrane review of music therapy for acquired brain injury (Bradt, et al., 2010) recommends further investigation into rhythm based techniques to treat hemiparesis in stroke patients, and that future studies need to examine the relationship between the frequency and duration of interventions and treatment effects.
The aim of this study is to examine whether or not a thirty minute, twice weekly, six week, home music therapy treatment, playing set musical patterns on instruments to music is feasible to deliver, and will lead to improved coordination, dexterity and activities of daily living in hemiparetic stroke patients.
Twelve patients will be recruited from Cambridgeshire Community Services NHS trust (CCS) who are between one month and two years post stroke with hemiparesis. Participants will have completed and been discharged from community rehabilitation for their upper limb and not be receiving any other treatment for arm function. They will be randomised into two groups: treatment (for immediate treatment following discharge from community rehab) and waiting list (beginning 9 weeks after baseline measure). Participants will be assessed at the beginning and end of treatment (just before starting and just after completing 6 weeks of treatment) by one of two experienced community occupational therapists under contract with CCS, who are also experienced in working with stroke patients and who will be blind to the experiment. The other three measures will be conducted by the chief investigator. The assessment tools will be the Action Research Arm Test (ARAT) and nine hole peg test (9HPT). There will also be a pre and post treatment semi-structured interview for each participant, which will be conducted by the chief investigator. ARAT and 9HPT assessments will be administered to all participants at the same time points: baseline and then at week 6, 9, 15 and 18. Data will be analysed to determine if the treatment is effective compared to no treatment (wait list) following community discharge, and whether earlier intervention (treatment group) yields better results for participants, all of whom will eventually receive treatment.
详细描述
CROSSOVER DESIGN After the stroke patients have finished their upper limb rehabilitation with CCS and are no longer receiving any physiotherapy or occupational therapy to improve it, this study aims to establish if their upper limb function is maintained, deteriorates, or improves. In order to do this the investigators will have a waiting list group who wait 9 weeks after the end of their CCS rehabilitation but are assessed at the same time points after their baseline measure as the treatment group. This enables us to compare the results of the treatment group with the waiting list group, in other words 'treatment compared to no treatment after CCS rehab has ended', and establish if the music therapy has been effective. The investigators can also compare the results of both groups and determine if the participants who received music therapy earlier performed any differently than the waiting list group.
The five repeated measures using the ARAT and 9HPT also allow each participant to be measured against themselves, comparing treatment with no treatment and establishing how the exercises using the musical instruments (TIMP treatment) have influenced their paretic arm use during activities of daily living.
STUDY GOALS AND OBJECTIVES
The study goal is to investigate the feasibility of delivering this music therapy treatment in stroke patients' homes twice a week for six weeks with the objective of answering the primary research question, which is:
- Does TIMP improve upper limb function after statutory rehabilitation has ceased to be effective and consequently ended?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •can consent to treatment
- •has completed community rehabilitation for upper limb paresis
- •any type and site of stroke
- •between 3 months and 5 years post stroke
- •can lift paretic hand onto a table whilst seated, without assistance from unaffected hand
- •some finger movement, which could be extension of one or more fingers
- •not receiving any other treatment for upper limb paresis during the course of this study (18 weeks from baseline measure)
排除标准
- •unable to consent to participate
- •unable to lift hand up onto a table without assistance
- •no finger movement
- •is receiving another treatment for upper limb hemiparesis
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: 10 to 30 minutes
The Action Research Arm Test. This includes 19 tasks using the affected and unaffected upper limb, for example picking up a block and placing it on a shelf or pouring water from one cup into another. Each task is timed and scored on a standardised scale (0 to 3). Maximum score of 57.
次要结局
- The nine hole peg test(2 minutes)
