跳至主要内容
临床试验/NCT03118648
NCT03118648Unknown不适用

Relations Between the Level Upper Limb Paresis Recovery in Output of the Hospital Unit Continued Care and Rehabilitation and Its Level of Use in Lifestyle at Three and Six Months

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
192
试验地点
1
主要终点
Motor Activity

研究概览

简要总结

The aim is to reduct spontaneous use an activities of daily living of the paretic upper limb after stroke i six months after patient discharge from rehabilitation center. The level of functional recovery at rehabilitation discharge could better guide rehabilitation strategies to enhance independence and participation in daily life.

This study aims to determine, in patients after stroke, the optimal affected upper limb recovery threshold at rehabilitation discharge to predict spontaneous level of use of affected upper limb in activities of daily living, six month later.

This study is a multicentric prognostic prospective cohort study. The main prognostic variable will be the Action Arm Test (ARAT, Lyle, 1981) score at rehabilitation discharge and the predicted variable will be the Motor Activity Log - 28 (Taub et al. 1993) score at 6 months post discharge.

详细描述

Adults after stroke will be recruited at post-acute rehabilitation discharge. Three evaluation times will be undertaken: at discharge, three and six months after discharge. Evaluation battery will focus on the three level of the Functioning International Classification: affected upper limb level of strength, proprioception and level of functional recovery, hemineglect, depression, cognition status, and activity level by doing a standardised instrumental task of daily living, and level of participation questionnaire. General characteristics will be taken into account: Age, social status, laterality.

At six months, the spontaneous level of affected upper arm use in daily living will also be assessed using accelerometers.

As the main aim of the study is to build a prediction model, the study size is calculated to observe a minimal number of events by potentially predictive variable. We consider here 7.5 events by independent variable (Vittinghof and McCulloch, 2007) and eight independent variables. According to literature review, we estimated that 35% of adults included in this study would spontaneously use their affected upper arm in activities of daily living six months after discharge. According to these data and considering 10% of protocol deviations, we calculated that 192 subjects will have to be included in the study. The inclusion duration will be 30 months.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 over 18 years old leaving the correctional institution with orientation back home
  • First stroke deficit with non-regressive clinical expression in 24 hours
  • Independent in activities of daily living and living at home and daily activities independence before the stroke. This earlier independence is confirmed by the absence of professional carers in personal care activities (yes / no)
  • Proper oral understanding as measured by score 7 in the language screening test LAST (Flamand-Roze et al, 2011)
  • No psychiatric history that led to hospitalization for more than six months
  • Patient has given its consent within the period provided after reading the briefing note
  • Patient affiliated or beneficiary of a social security scheme.

排除标准

  • Lack of minimum functional motor recovery in paretic upper limb allowing the patient to go put hand to his mouth and to realize do a 45 degrees abduction with the paretic upper limb.
  • Barthel Index score (BI) less than or equal to
  • It is suggested in the literature that a score less than or equal to 40 is a key score of total dependence
  • Persistent severe hemineglect (bells test score > 6).

结局指标

主要结局

Motor Activity

时间窗: Month 6

Score of Motor Activity Log scale

次要结局

  • Action Arm(Day 180)
  • "Mesure des HAbitudes de VIE" (MHAVIE)(Day 180)
  • "Montreal Cognitive Assessment" (MoCA)(Day 180)
  • Aphasic Depression Rating (ADRS)(Day 180)
  • Unilateral spatial neglect (NSU) in the vicinity of extrapersonal space(Day 180)
  • Cognitive abilities(Day 180)

研究者

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

研究点 (1)

Loading locations...

相似试验