1 Anglia Ruskin University, Cambridge, UK.
2 Music Therapy Program, Temple University, Philadelphia, PA, USA.
Clin Rehabil. 2018 Jan;32(1):18-28. doi: 10.1177/0269215517717060. Epub 2017 Jun 23.
To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke.
A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes.
Participants' homes across Cambridgeshire, UK.
Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation.
Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks.
Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor.
A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection.
It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants.
ClinicalTrials.gov identifier NCT 02310438.
评估一项随机对照试验评估音乐疗法作为中风后上肢偏瘫家庭干预的可行性。
一项先导性可行性随机对照试验,采用交叉设计。通过使用计算机生成的、隐藏在不透明信封中的随机数,由统计学家进行随机分组。
英国剑桥郡的参与者家中。
11 名中风后 3-60 个月、从社区康复中出院的上肢偏瘫患者。
每位参与者在 12 次单独的临床接触中进行治疗性乐器演奏,每周两次,持续六周。
通过在 12 个月内从三个社区中风团队招募参与者、失访率、完成治疗和成功收集数据来评估可行性。在干预前后进行了结构化访谈,以确定参与者的耐受性和偏好。在干预前后的第 1、6、9、15 和 18 周,由盲法评估者收集行动研究上肢测试和 9 孔钉测试数据。
共邀请了 14 名参与者中的 11 名(干预组 n=6,候补组 n=5)。共有 10 人完成了治疗和数据收集。
由于没有关于许多筛选出的合格患者的数据,因此无法确定更大规模的试验是否可行。对治疗的依从性、保留率和访谈反应可能表明该干预措施对参与者具有激励作用。
ClinicalTrials.gov 标识符 NCT 02310438。