NL-OMON35943已完成不适用
Collection of thigh acceleration data to evaluate the Neurostep® gait event detection performance in subjects with foot drop secondary to an upper motor neuron lesion - Collection of thigh acceleration data for gait event detection
eurostream Technologies, G.P.0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female, >= 18 years of age;
- •2. Have a unilateral and persisting weakness or lack of control in ankle control during gait secondary to a chronic upper motor neuron lesion (>6 months ago);
- •3. The subject*s gait impairment involves a clinically significant deficit in ankle control during gait, including a foot drop;
- •4. Be able to stand and walk at least 10 meters without an AFO (other assistive devices are allowed if needed), while requiring no more than close supervision;
- •5. Subject must have an average, self-selected, comfortable walking speed lower than 1.0 meter per second;
- •6. Have a passive ankle range of motion that allows dorsiflexion to neutral (be able to stand upright with both heels touching the floor while hip and knee are in the neutral position) and 20 degrees in plantar flexion;
- •7. Subject is able to provide informed consent;
- •8. Subject must be willing and able to follow all study procedures including attendance at clinics for scheduled study visits.;At least three subjects must be recruited with the following additional criteria:
- •9. A plantar flexion insufficiency (i.e., lack of control or weakness), defined as the inability to lift the heel (at least 2 cm) during single-leg stance while standing on the affected leg;
- •10. Subject must have an average self-selected comfortable walking speed lower than 0.5 meter per second on average.
- •(Note: At least three of the subjects must have criterion 9 and three of the subjects must have criterion 10 but it is not required neither prohibited that they meet criteria 9 and 10 simultaneously).
排除标准
- •1. Women who are pregnant;
- •2. The subject has uncompensated hemi-neglect or pushers syndrome;
- •3. Subject has a bilateral gait impairment or bilateral impairment in ankle control;
- •4. Subjects with excessive spasticity: with a modified Ashworth scale score of more than 3;
- •5. Subject exhibits other gait disorders that would impact his/her gait ability (e.g., hip impairment, significant degenerative joint disease at the hip/knee).
研究者
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