Improving Gait Adaptability in Hereditary Spastic Paraplegia During Task-specific Training on the C-Mill: Towards Evidence-Based and Individually Tailored Rehabilitation
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:
- To study the effect of ten 1-hour sessions C-Mill training on gait adaptability in participants with pure-HSP.
- 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
- 否
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))
