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临床试验/NCT04180098
NCT04180098已完成不适用

Improving Gait Adaptability in Hereditary Spastic Paraplegia During Task-specific Training on the C-Mill: Towards Evidence-Based and Individually Tailored Rehabilitation

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
The mean changes in time scores of the obstacle subtask of the emory functional ambulation profile

研究概览

简要总结

This study evaluates the effects of ten hours C-mill training on gait adaptability in participants with hereditary spastic paraplegia (HSP). Half of the participants start with five weeks of C-mill training (ten 1-hour sessions). The other participants are placed on a waiting list, which is followed by the same five weeks of C-mill training (ten 1-hour sessions). It is hypothesized that ten hours of context specific C-mill training is effective in improving gait adaptability in participants with pure HSP.

详细描述

Hereditary spastic paraplegia (HSP) is a relatively common, slowly progressive movement disorder that seriously impacts on gait capacity. Patients with HSP experience incremental muscle stiffness, muscle weakness and balance problems and, as a consequence, increasing difficulties to adjust their gait pattern to changing environmental demands. This is a major problem as such 'gait adaptability' is critical for independent and safe mobility in daily life. Impaired gait adaptability will also result in falls and fall-related injuries and reduce quality of life. Therefore, there is an urgent need for evidence-based rehabilitation interventions to improve gait adaptability in patients with HSP. Participants train gait adaptability via obstacle negotiation, precision stepping and unexpected accelerations and decelerations. The strategies are trained in a safe environment on the C-Mill, a treadmill providing augmented reality via visual and acoustic cues.

Objectives

This study aims to promote an essential step towards evidence-based and individually tailored gait rehabilitation in participants with hereditary spastic paraparesis. The objectives are twofold:

  1. To study the effect of ten 1-hour sessions C-Mill training on gait adaptability in participants with pure-HSP.
  2. To study the effect of ten 1-hour sessions C-Mill training on spatiotemporal and functional capacity parameters and to identify key-determinants of C-Mill training efficacy in participants with pure-HSP.

It is hypothesized that ten hours of context specific C-mill training is effective in improving gait adaptability in participants with pure HSP, as measured with the obstacle subtask of the emory functional ambulation profile (E-FAP).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The mean changes in time scores of the obstacle subtask of the emory functional ambulation profile

时间窗: Pre-intervention (week 0) till post-intervention (week 6)

Patients are asked to negotiate a ten meter obstacle course. The number of seconds it takes to complete the subtask is recorded, and multiplied by a factor corresponding to the level of assistive devices used. A lower time score indicates better obstacle negotiation

次要结局

  • Mean changes in number of falls and near falls(Pre-intervention (week 0) and after the follow-up period of fifteen weeks (experimental group week 21, control group week 27))
  • The mean change in the time score on the ten meter walk test(Pre-intervention (week 0) till post-intervention (week 6))
  • Mean changes of activity levels measured as time spent active of passive during 24 hours(Pre-intervention (week 0) till post-intervention (week 6))
  • Mean changes in spatio-temporal gait parameters(Pre-intervention (week 0) till post-intervention (week 6))
  • The mean change of the mini balance evaluation system(Pre-intervention (week 0) till post-intervention (week 6))
  • The mean changes in scores of the activities specific balance confidence scale(Pre-intervention (week 0) till post-intervention (week 6))
  • The mean change in the time score on the walking adaptability ladder test(Pre-intervention (week 0) till post-intervention (week 6))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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