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临床试验/NCT06192953
NCT06192953招募中不适用

Early Functional Proprioceptive Stimulation Post-stroke

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年5月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
1
主要终点
Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS)

研究概览

简要总结

The main objective of our study is to evaluate the impact of the use of Functional Proprioceptive Stimulation (FPS) on the recovery of the postural and motor functional capacities of the patient in the subacute phase of a stroke.

The hypothesis is that the use of FPS has a positive impact on the recovery of the patient's functional abilities, as well as on the duration of treatment until the sit/stand transfers are completed.

To evaluate this potential effect,there will be a randomization with two groups : one will have 5 sessions a week for 6 weeks maximum of SPF and the other groupe will have the same sessions but with the device stettled but not activated.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patient hospitalized at Cimiez University Hospital;
  • •Ischemic or hemorrhagic cerebrovascular accident (CVA) of less than two weeks;
  • •Hemiparesis requiring rehabilitation treatment;
  • •Patient with a SFPASS score ≤ 6;
  • •Patient affiliated to or beneficiary of a social security scheme;
  • •Signature of informed consent

排除标准

  • •NIHSS > 20;
  • •Muscle spasticity of the lower limbs requiring botulinum toxin injection
  • •Inability to understand rehabilitation instructions;
  • •Vulnerable people
  • •Pregnant women, parturients and breastfeeding mothers, persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent and persons admitted to a health or social establishment for purposes other than research,
  • •Adults who are subject to a legal protection measure or who are unable to express their consent.

研究组 & 干预措施

Stimulated group

Experimental

5 sessions per week for 6 weeks maximum of reeducation with Functional Proprioceptive Stimulation

干预措施: Functional Proprioceptive Stimulation (Other)

Simulated group

No Intervention

5 sessions per week for 6 weeks maximum with the device of Functional Proprioceptive Stimulation settled but not activated

结局指标

主要结局

Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS)

时间窗: 10 weeks

The SFPASS is a short instrument used to assess balance in lying, sitting and standing positions. It was designed specifically for stroke patients and is appropriate for all individuals, regardless of their postural performance. SFPASS focuses on mobility in bed and sitting to standing transfer. It is composed of 5 items rated on a 3-point scale with total scores ranging from 0 to 15 and is evaluated by a health professional.

Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS)

时间窗: Inclusion

The SFPASS is a short instrument used to assess balance in lying, sitting and standing positions. It was designed specifically for stroke patients and is appropriate for all individuals, regardless of their postural performance. SFPASS focuses on mobility in bed and sitting to standing transfer. It is composed of 5 items rated on a 3-point scale with total scores ranging from 0 to 15 and is evaluated by a health professional.

Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS)

时间窗: Every week during 5 weeks maximum

The SFPASS is a short instrument used to assess balance in lying, sitting and standing positions. It was designed specifically for stroke patients and is appropriate for all individuals, regardless of their postural performance. SFPASS focuses on mobility in bed and sitting to standing transfer. It is composed of 5 items rated on a 3-point scale with total scores ranging from 0 to 15 and is evaluated by a health professional.

Score at the Short Form of Postural Assessment Scale for Stroke Patients (SFPASS)

时间窗: 6 weeks

The SFPASS is a short instrument used to assess balance in lying, sitting and standing positions. It was designed specifically for stroke patients and is appropriate for all individuals, regardless of their postural performance. SFPASS focuses on mobility in bed and sitting to standing transfer. It is composed of 5 items rated on a 3-point scale with total scores ranging from 0 to 15 and is evaluated by a health professional.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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