跳至主要内容
临床试验/NCT06608121
NCT06608121已完成不适用

Study for the Development and Evaluation of Personalised Muscle Effort Generation Models for Patients With Upper Limb Motor Deficits

Pôle Saint Hélier2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
2
主要终点
Description of the residuals of the effort generation models, defined as the difference between the actual effort values and the modelled values: o Average residual of the models (mean ± standard deviation) (Main Evaluation Criterion)

研究概览

简要总结

Upper limb motor impairments are common. They affect quality of life and can lead to dependency. They are mainly due to neurological conditions such as stroke, multiple sclerosis, and traumatic spinal cord injury. However, the contractile properties of muscle, in particular the maximum force that can be generated voluntarily (MVF) depending on joint angle and motion speed, have been mainly studied and modeled in healthy people. This study aims at developing mathematical models describing residual muscle forces in patients with motor impairments. The knowledge could guide patients' rehabilitation and could be useful for the development of robotic assistance systems that use patients' residual capacities to control the level of assistance provided.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18 and 85
  • A patient who is a member or beneficiary of a social security scheme
  • Patients hospitalised at the Saint-Hélier rehabilitation centre for a stroke more than 15 days old, MS or SCI
  • Patients with a motor deficit ≤3/5 on the MRC (Medical Research Council) scale in both internal-external shoulder rotation and elbow flexion-extension.
  • Patient with voluntary consent to participate in this study.

排除标准

  • Spasticity >3/4 on the Aschworth scale in the shoulder abductor or elbow flexor muscles.
  • Cognitive impairment that may interfere with measurements (MOCA < 20/30)
  • Presence of a pressure sore > stage 2 at the ischial level
  • Recent trauma to limbs or spine
  • Decompensated heart disease or other unbalanced pathology which contraindicates or may hinder isokinetic testing.
  • Persons deprived of their liberty by a judicial or administrative decision
  • Pregnant women, women in labour or nursing mothers.

结局指标

主要结局

Description of the residuals of the effort generation models, defined as the difference between the actual effort values and the modelled values: o Average residual of the models (mean ± standard deviation) (Main Evaluation Criterion)

时间窗: From enrollment to the end of the participation at maximum 7 days

次要结局

未报告次要终点

研究者

发起方
Pôle Saint Hélier
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验