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临床试验/NCT02236091
NCT02236091终止不适用

Monitoring Everyday Life Motor Activity in Children

Rob Labruyere1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
40
试验地点
1
主要终点
Counts per minute at time point T=1

研究概览

简要总结

The overall aim of this project is to monitor everyday life activity of children with neurological disorders undergoing rehabilitation using wearable sensors capable of accurate and unobtrusive long-term measurement.

Specific objectives:

  1. To adapt the sensors for the use by children with neurological disorders. The focus lies on the exact positioning and the investigation of the needed amount of IMUs.
  2. To validate the sensor data with collected video recordings and to develop specific algorithms to automatically extract specific movements and to analyze long-term sensor recordings.
  3. To perform a cross-sectional study to assess intensity, task-specificity and duration of upper and lower limb activity during rehabilitation. There, we aim to gain objective information about levels and types of activity during rehabilitation in relation to age, gender and disorder.
  4. To conduct a responsiveness study to assess whether or not the sensor output is able to highlight changes over time during rehabilitation.

Therefore, at time point T=0 (shortly after admission to our center), participants are equipped with 3 inertial measurement units (1 at each wrist and 1 at the sternum). Additionally, a small wearable camera is mounted to the chest. The participants then return to their everyday life for 4 hours (no therapies, measurement period is in the evening). Afterwards, the equipment is removed again. To investigate responsiveness, the same protocol is being repeated 4 weeks later (time point T=1).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

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

入选标准

  • Various neuro-orthopedic diagnoses. Broad inclusion criteria are required to better generalize study results to the patient population of our center.
  • Both walking or in wheelchair, but mobility independent from assisting people
  • Cognitive ability to be able to follow simple verbal instructions.
  • Signed informed consent from legal guardians and also from adolescents aged 15 years or older before study onset.

排除标准

  • 未提供

结局指标

主要结局

Counts per minute at time point T=1

时间窗: At T=1 (4 weeks after T=0)

From the wearable sensors at the wrist, a count/minute statistic is calculated that reflects the amount of activity the child performs during that time.

Counts per minute at time point T=0

时间窗: At T=0

From the wearable sensors at the wrist, a count/minute statistic is calculated that reflects the amount of activity the child performs during that time.

次要结局

  • Motor assessment: Melbourne 2 at time point T=1(At T=1 (4 weeks after T=0))
  • Motor assessment: Melbourne 2 at time point T=0(At T=0)
  • Parent questionnaire: Abilhand-Kids at time point T=1(At T=1 (4 weeks after T=0))
  • Parent questionnaire: Abilhand-Kids at time point T=0(At T=0)

研究者

发起方
Rob Labruyere
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rob Labruyere

PhD

University Children's Hospital, Zurich

研究点 (1)

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