McDaid Catriona, Fayter Debra, Booth Alison, O'Connor Joanne, Rodriguez-Lopez Rocio, McCaughan Dorothy, Bowers Roy, Iglesias Cynthia P, Lalor Simon, O'Connor Rory J, Phillips Margaret, Ramdharry Gita
Department of Health Sciences, University of York, York, UK.
Centre for Reviews and Dissemination, University of York, York, UK.
BMJ Open. 2017 Sep 5;7(9):e015927. doi: 10.1136/bmjopen-2017-015927.
To assess the effectiveness of orthotic devices for the management of instability of the knee in adults with a neuromuscular disorder or central nervous system disorder.
A systematic review of primary studies.
Community.
Adults with a neuromuscular disorder or central nervous system disorder and impaired walking ability due to instability of the knee.
Orthoses with the clinical aim of controlling knee instability, for example, knee-ankle-foot orthoses, ankle-foot orthoses and knee orthoses or mixed design with no restrictions in design or material.
Condition-specific or generic patient-reported outcome measures assessing function, disability, independence, activities of daily living, quality of life or psychosocial outcomes; pain; walking ability; functional assessments; biomechanical analysis; adverse effects; usage; patient satisfaction and the acceptability of a device; and resource utilisation data.
Twenty-one studies including 478 patients were included. Orthotic devices were evaluated in patients with postpolio syndrome, poststroke syndrome, inclusion body myositis and spinal cord injury. The review included 2 randomised controlled trials (RCTs), 3 non-randomised controlled studies and 16 case series. Most were small, single-centre studies with only 6 of 21 following patients for 1 year or longer. They met between one and five of nine quality criteria and reported methods and results poorly. They mainly assessed outcomes related to gait analysis and energy consumption with limited use of standardised, validated, patient-reported outcome measures. There was an absence of evidence on outcomes of direct importance to patients such as reduction in pain and falls.
There is a need for high-quality research, particularly RCTs, of orthotic devices for knee instability related to neuromuscular and central nervous system conditions. This research should address outcomes important to patients. There may also be value in developing a national registry.
PROSPERO (CRD42014010180).
评估矫形器对患有神经肌肉疾病或中枢神经系统疾病的成人膝关节不稳的治疗效果。
对原始研究的系统评价。
社区。
患有神经肌肉疾病或中枢神经系统疾病且因膝关节不稳而行走能力受损的成年人。
以控制膝关节不稳为临床目的的矫形器，例如膝踝足矫形器、踝足矫形器和膝关节矫形器，或设计或材料无限制的混合设计。
特定疾病或通用的患者报告结局指标，用于评估功能、残疾、独立性、日常生活活动、生活质量或心理社会结局；疼痛；行走能力；功能评估；生物力学分析；不良反应；使用情况；患者满意度和器械的可接受性；以及资源利用数据。
纳入了21项研究，共478例患者。对患有小儿麻痹后遗症、中风后综合征、包涵体肌炎和脊髓损伤的患者进行了矫形器评估。该评价包括2项随机对照试验（RCT）、3项非随机对照研究和16个病例系列。大多数是小型单中心研究，21项研究中只有6项对患者进行了1年或更长时间的随访。它们符合9项质量标准中的1至5项，报告的方法和结果较差。它们主要评估与步态分析和能量消耗相关的结局，对标准化、经过验证的患者报告结局指标的使用有限。缺乏对患者直接重要的结局的证据，如疼痛减轻和跌倒减少。
需要针对与神经肌肉和中枢神经系统疾病相关的膝关节不稳的矫形器进行高质量研究，尤其是RCT。这项研究应关注对患者重要的结局。建立一个国家登记册可能也有价值。
PROSPERO（CRD42014010180）。
