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临床试验/NCT03424031
NCT03424031终止不适用

A Very Early Standing Study in Elderly Stroke

Centre Hospitalier Régional d'Orléans1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2017年1月31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
入组人数
45
试验地点
1
主要终点
PASS score

研究概览

简要总结

Functional recovery is one of the main issues in the management of stroke and there are various ways in rehabilitation to promote this recovery.

Verticalization is a technique whose benefits have been widely demonstrated, particularly in neurology. Although commonly used in the rehabilitation of stroke, evidence is still lacking as to its impact in this specific care.

Verticalization is underutilized in two situations: in the hyper acute phase as well as in elderly and very deficient patients. It has, however, been shown that the precocity of the treatment allows a better functional recovery. Similarly, the re-education of the elderly is also debated since it has long been mentioned that age was a factor of poor prognosis, the objectives are sometimes underestimated. However, several studies have shown that with the same rehabilitation, elderly patients recover as much as younger patients. The differences found are at least in part due to "less rehabilitation" of older stroke patients.

The different existing data lead us to the hypothesis that the verticalization of the elderly hemiplegic patient in acute phase would allow a better functional recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

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

入选标准

  • •Ischemic or hemorrhagic stroke
  • •Age > 70
  • •Modified Rankin Scale (MRS) pre stroke : 0 or 1
  • •Admission in the neuro vascular unit less than 48 hours after the onset of symptoms
  • •NIHSS Item 6 for lower extremity motor skills: 3 or 4
  • •Modified Functional Ambulation Classification : 0
  • •Affiliated to a social security scheme

排除标准

  • •History of stroke with motor sequencing limiting walking
  • •Arterial stenosis limiting the sunrise before D4 (identified by Doppler)
  • •Symptomatic orthostatic hypotension known or present in the acute phase
  • •Patients who will be referred to a structure (UNV or other) outside the department
  • •Fracture, orthopedic disorder or any other complication preventing verticalization
  • •Refusal of the patient to participate in the study or to be verticalized
  • •Patients under guardianship
  • •Patients deprived of their liberty by an administrative decision

研究组 & 干预措施

Verticalization

Experimental

the patient will be placed in the most vertical position possible.

干预措施: Verticalization (Procedure)

Passive mobilization

No Intervention

Passive mobilization of the lower limb deficit

结局指标

主要结局

PASS score

时间窗: 4th month

the PASS score (score of 36) will be evaluated at 4 months (t2) in single blind (by a physiotherapist who will not be aware of the reeducation performed).

次要结局

  • Percentage of days with stools(Day 15)
  • functional recovery(Day 15)
  • Evaluation of the walk quality(Month 4)
  • Semi-quantitative evaluation(Day 15)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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