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临床试验/NCT05492604
NCT05492604终止不适用

Study of Connected Soles With Pressure Sensors in the Evaluation of Gait Disorders in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年3月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
18
试验地点
2
主要终点
Validy of gait velocity

研究概览

简要总结

Chronic Inflammatory Demyelinating Polyneuropathies (CIDP) are acquired, autoimmune and inflammatory neuropathies leading mainly to gait disorders in patients. Assessment of gait disorders is a major component of therapeutic management, but evaluation is sometimes difficult due to the fluctuating nature of the symptoms. The principal objective of this study is to compare the walking speed of patients with a reference method (GAITRITE® walkway) and an innovative one (FEETME® connected soles) with the aim of validating the use of theses connected soles in CIDP gait disorders evaluation.

详细描述

Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) present multifactorial gait disorders (motor deficit, fatigability, sensory and proprioceptive disorders with ataxia). Gait disorders are the main cause of disability in these patients. Assessment of gait disorders is a major component of therapeutic management, but evaluation is sometimes difficult due to the fluctuating nature of the symptoms. For many patients, there is indeed a fluctuating nature of gait disorders depending on the administration of treatments (reappearance of symptoms between two immunoglobulin -IgIV- infusions) conditioning the interval of two infusions. In the context of a shortage of IgIV and given the high cost of this treatment, it is of major importance to adapt the treatment as closely as possible to the needs of the patients.

Objective evaluation methods of gait disorders used in current practice have several drawbacks: chronophagy, operator-dependency, heterogeneity of data, implementation in hospital. Moreover, these methods often lack sensitivity to detect some changes. Portable evaluation methods with pressure sensors (including FEETME® connected soles) have been developed and studied in several neurological pathologies. These systems allow one-off evaluations with standardised tests but also continuous monitoring in an ecological environmentBy comparing several walk parameters with a reference method (GAITRITE® walkway) and an innovative one (FEETME® connected soles) , we want to validate the use of the connected soles in gait dirorders evaluation for CIDP patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Patients of both sexes, aged 18 to 75 years old.
  • Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) defined or probable according to the EFNS/PNS (European Federation of Neurological Societies/Peripheral Nerve Society) diagnostic criteria proposed in
  • Patients treated with intravenous polyvalent immunoglobulins.
  • Patients with gait impairment related to CIDP, not requiring technical assistance, with an ONLS (Overall Neuropathy Limitations Scale) score of 1 or 2/7 on the lower limbs at inclusion.
  • Patients affiliated to or benefiting from a social security scheme.
  • Patients giving their free and informed consent to participate after information about the research.

排除标准

  • Pregnant or breastfeeding women.
  • Patients placed under guardianship, curatorship or safeguard of justice.

研究组 & 干预措施

Connected soles

Experimental

FEETME® connected tool

干预措施: Clinical examination (Other)

Connected soles

Experimental

FEETME® connected tool

干预措施: Functional scales (Other)

Connected soles

Experimental

FEETME® connected tool

干预措施: Walking test (Diagnostic Test)

Treadmill

Other

Reference system the GAITRite® walkway

干预措施: Clinical examination (Other)

Treadmill

Other

Reference system the GAITRite® walkway

干预措施: Functional scales (Other)

Treadmill

Other

Reference system the GAITRite® walkway

干预措施: Walking test (Diagnostic Test)

结局指标

主要结局

Validy of gait velocity

时间窗: Day 0

To determine the validy of gait velocity in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) patients, measured by FEETME® connected soles vs reference system the GAITRite® walkway.

次要结局

  • Step length(Day 0)
  • Pitch attack ratio (heel/toe)(Day 0)
  • Walking pace(Day 0)
  • Heel pressure measurements(Day 0)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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