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临床试验/NCT04028999
NCT04028999已完成不适用

Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年7月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Evaluate the effects of the EO31 shoulder with Goal Attainment Scale (GAS) scale

研究概览

简要总结

Upper limb (UL) impairment is a common deficit following stroke with only an estimated 20 per cent of patients recovering function.

详细描述

Upper limb (UL) impairment is a common deficit following stroke with only an estimated 20 per cent of patients recovering function. Pain associated with UL impairment due to multifactorial causes is a frequent symptom in patients with stroke. Occupational therapy techniques focus on the implementation of positioning techniques and the use of supportive devices (SD) such as slings aimed to prevent pain; therefore increase daily function, participation and hence quality of life. At present, positioning principles of the hemiplegic shoulder exist in clinical practice. These are aimed at prevention of pain associated with UL Impairment; however there is no clear consensus among professionals of particular SD that should be implemented for adults with stroke

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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
否

入选标准

  • •Having suffered in the last 6 months maximum a first stroke responsible for hemiplegia.
  • •Finding a clinical 5mm appendix, or with shoulder pain requiring prescription a scarf.
  • •Boston Diagnostic Aphasia Examination (BDAE) >
  • •Consent of the patient
  • •Patient affiliated or benefiting from a social security scheme

排除标准

  • •Stroke recurrence, or stroke more than 6 months-old
  • •Patient already wearing a coaptation scarf
  • •Presence of lymphoedema, venous thrombosis of the upper limb
  • •Neoprene allergy
  • •Severe cognitive impairment: Mini-Mental State (MMS) <15
  • •Patient being part of another care protocol
  • •Adult under the protection of justice, tutors or curators
  • •Pregnant or lactating woman.

研究组 & 干预措施

the EO31 shoulder sling

Experimental

To develop and evaluate the effects of the EO31 shoulder sling for the prevention of pain, subluxation, spasticity, as well as effect on increasing functional use of the UL in activities of daily living.

干预措施: Evaluate the effects of the EO31 shoulder sling in adults post-stoke (Device)

结局指标

主要结局

Evaluate the effects of the EO31 shoulder with Goal Attainment Scale (GAS) scale

时间窗: 5 weeks

GAS (Goal Attainment Scale) scores will be described with regards to the 3 client-centred objectives. The score for each objective is comprised between -2 (when objective is not achieve) to 2 (achieve objective).

次要结局

  • motor function of upper limb with Chedoke Arm and Hand Activity Inventory (CAHAI) scale(baseline)
  • Number of daily use of the upper limb sling(5 weeks)
  • motor function of upper limb with CAHAI scale(5 weeks)
  • Evaluate shoulder pain with Visual Analog Scale for Pain (EVA scale)(24 hours)
  • Evaluate shoulder pain with EVA scale(baseline)
  • questionnaire for quality of patient's life(5 weeks)
  • Spasticity with TARDIEU scale(5 weeks)
  • Clinical measure of appendage(5 weeks)
  • Evaluate shoulder pain with EVA scale(5 weeks)
  • Spasticity with TARDIEU scale(baseline)
  • Spasticity with TARDIEU scale(7 days)
  • Spasticity with TARDIEU scale(14 days)
  • Clinical measure of appendage(baseline)
  • Clinical measure of appendage(7 days)
  • Clinical measure of appendage(14 days)
  • motor function of upper limb with CAHAI scale(7 days)
  • questionnaire for quality of patient's life(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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