Physiotherapy, University of West Attica, Egaleo, Greece
Physiotherapy, University of Patras School of Health Sciences, Patras, Greece.
BMJ Open. 2022 Mar 25;12(3):e056943. doi: 10.1136/bmjopen-2021-056943.
A great heterogeneity characterises the paediatric population with ataxia, which has been studied poorly. The lack of postural control and coordination, in addition with features of the 'ataxic' gait are linked with functional limitations. Studies on physiotherapy interventions for children with ataxia are highly needed for identifying optimal training strategies for improving motor and functional related skills.
A stratified randomised control clinical trial of a 4-week functional partial body weight support treadmill training, (5 days/week 45 min/day) and 2-month follow-up period will be applied in children with ataxia, aged 8-18 years old with Gross Motor Function Classification System II-IV. Participants will be allocated to experimental group (intervention and usual care) or control group (usual care), using stratified randomisation process into two strata (progressive and non-progressive ataxia). Participants will be assessed at baseline, by the end of the 4-week period and by the end of a 2-month period as a follow-up measurement. Motor and functional skills will be assessed using the Gross Motor Function Measure-D and E, the Pediatric Balance Scale, the 10-meter walk test, the 6-minute walk test, the Scale for Assessment and Rating Ataxia, the timed up and go test and children's spatiotemporal gait features will be assessed through GaitSens software recording over a 2 min low treadmill gait speed, while three-dimensional gait analysis will be performed for kinetic and kinematic analysis of the lower limbs in all three levels of movement. Two-way mixed Analysis of Variance (ANOVA) with factors 'intervention' (between group) and 'time' (within group) will be used for the analysis of all parameters. Analysis of Covariance (ANCOVA) will be used in case of imbalance of baseline measurements. Statistical significance will be set at p<0.05 using the statistical package SPSS V.21.00.
University of West Attica (study's protocol: 14η/26-04-2021) and 'ATTIKON' General University Hospital of Athens (study's protocol: Γ ΠΑΙΔ, ΕΒΔ 149/20-3-2020). Trial results of the main trial will be submitted for publication in a peer-reviewed journal and/or international conference.
ISRCTN54463720.
共济失调患儿表现出很大的异质性，但对此研究甚少。姿势控制和协调能力的缺乏，以及“共济失调”步态的特征，与功能受限有关。因此，非常需要研究针对共济失调儿童的物理治疗干预措施，以确定改善运动和功能相关技能的最佳训练策略。
我们将对 8-18 岁患有共济失调且粗大运动功能分级系统 II-IV 的儿童进行一项为期 4 周的功能性部分体重支持跑步机训练（每周 5 天，每次 45 分钟）和 2 个月随访的分层随机对照临床试验。参与者将根据进展性和非进展性共济失调分为两个层（实验组和对照组），通过分层随机过程进行分组。参与者将在基线、4 周后和 2 个月的随访测量时进行评估。运动和功能技能将使用粗大运动功能测量-D 和 E、儿科平衡量表、10 米步行测试、6 分钟步行测试、共济失调评估量表、计时起立行走测试和儿童时空步态特征进行评估，通过 GaitSens 软件记录 2 分钟低跑步机步行速度下的步态，同时进行三维步态分析，以进行下肢在所有三个运动水平的动力学和运动学分析。将使用双因素混合方差分析（ANOVA）对所有参数进行分析，因素为“干预”（组间）和“时间”（组内）。如果基线测量不平衡，将使用协方差分析（ANCOVA）。使用 SPSS V.21.00 统计软件包设置统计显著性水平为 p<0.05。
西阿提卡大学（研究方案：14η/26-04-2021）和雅典 Attikon 综合大学医院（研究方案：Γ ΠΑΙΔ，ΕΒΔ 149/20-3-2020）。主要试验的试验结果将提交给同行评议期刊和/或国际会议发表。
ISRCTN54463720。
