School of Rehabilitation Sciences, Faculty of Medicine, Université Laval, Quebec City, QC, G1V 0A6, Canada.
Center for Interdisciplinary Research in Rehabilitation and Social Integration, Centre Intégré Universitaire de Santé Et de Services Sociaux de La Capitale-Nationale, 525 Wilfrid-Hamel Boulevard, Quebec City, QC, G1M 2S8, Canada.
BMC Pediatr. 2023 Sep 26;23(1):485. doi: 10.1186/s12887-023-04303-8.
Self-directed mobility during childhood can influence development, social participation, and independent living later in life. For children who experience challenges with walking, manual wheelchairs (MWCs) provide a means for self-directed mobility. An effective MWC skills training program exists for adults, but controlled trials have not yet been documented in children and adolescents. This paper outlines the protocol for a multi-centre randomized wait-list controlled trial. The primary objective is to test the hypothesis that children and adolescents who receive MWC skills training will have higher MWC skills capacity compared to children and adolescents in the control group who receive usual care. The secondary objectives are to explore the influence of MWC skills training in children and adolescents (MWC use self-efficacy and satisfaction with participation in meaningful activities), and parents (perceived MWC skills); and to measure retention three months later.
A multi-centre, parallel-group, single-blind randomized wait-list controlled trial will be conducted. A sample of 60 children and adolescents who use MWCs will be recruited in rehabilitation centres, specialized schools, and the communities of three Canadian cities. Participants will be randomized (1:1) to the experimental (Wheelchair Skills Training Program [WSTP]) or wait-list control group (usual care). Performance-based and self-report measures will be completed at baseline (T1), three months (post-intervention, T2), and three months post-intervention (T3). The primary outcome will be MWC skills capacity post-intervention. Secondary outcomes will be MWC use self-efficacy and satisfaction with participation of the child/adolescent, and parent-perceived MWC skills. The WSTP will consist of 12 sessions, 45-60 min each, delivered 1-2 times per week by trained personnel with health professions education. Training will be customized according to the child's baseline skills and participation goals that require the use of the MWC. The wait-list control group will receive usual care for 3 months and then receive the WSTP after completing T2 evaluations. Data will be analysed using ANCOVA (controlling for baseline scores).
MWC skills training may be one way to improve self-directed mobility and related outcomes for children and adolescents. The results of this multi-centre randomized wait-list controlled trial will allow for the effectiveness of the intervention to be evaluated in a variety of clinical contexts and geographical regions.
ClinicalTrials.gov: NCT05564247, Version October 3, 2022.
儿童时期的自主移动能力会影响其日后的发展、社会参与度和独立生活能力。对于那些在行走方面存在困难的儿童来说,手动轮椅(MWC)为其提供了自主移动的手段。现已有一套成人使用的有效 MWC 技能培训方案,但尚未有针对儿童和青少年的对照试验。本文概述了一项多中心随机候补对照试验的方案。主要目的是检验假设,即接受 MWC 技能培训的儿童和青少年的 MWC 技能能力将高于接受常规护理的对照组儿童和青少年。次要目的是探索 MWC 技能培训对儿童和青少年(MWC 使用自我效能感和对有意义活动的参与满意度)和家长(感知 MWC 技能)的影响,并在三个月后测量保留率。
将开展一项多中心、平行组、单盲随机候补对照试验。在加拿大三个城市的康复中心、特殊学校和社区招募 60 名使用 MWC 的儿童和青少年参与者。参与者将按照 1:1 的比例随机分配到实验组(轮椅技能培训计划[WSTP])或候补对照组(常规护理)。在基线(T1)、三个月(干预后,T2)和干预后三个月(T3),将完成基于表现和自我报告的测量。主要结局指标是干预后的 MWC 技能能力。次要结局指标是儿童/青少年的 MWC 使用自我效能感和对参与活动的满意度,以及家长感知的 MWC 技能。WSTP 将包括 12 次课程,每次 45-60 分钟,由具有健康专业教育背景的培训人员每周 1-2 次进行。培训将根据儿童的基线技能和需要使用 MWC 的参与目标进行定制。候补对照组将在接受 3 个月的常规护理后,在完成 T2 评估后接受 WSTP。将使用协方差分析(控制基线分数)对数据进行分析。
MWC 技能培训可能是提高儿童和青少年自主移动能力及相关结局的一种方法。这项多中心随机候补对照试验的结果将使我们能够在各种临床环境和地理区域评估干预的有效性。
ClinicalTrials.gov:NCT05564247,版本 2022 年 10 月 3 日。