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临床试验/NCT04803578
NCT04803578已完成不适用

The Effectiveness of Rehabilitation in Gait Recovery After Knee or Hip Arthroplasty: a Pilot Observational Study Based on Kinematic and Kinetic Parameters

Fondazione Don Carlo Gnocchi Onlus1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Change in Gait Variable Scores

研究概览

简要总结

This study aims to evaluate the effectiveness of rehabilitation on gait recovery in subjects after knee or hip arthroplasty. Assessment is performed the day after admission (T0) and the day of discharge (T1), in a post-acute rehabilitation hospital, through an optoelectronic system (BTS DX-400). Other functional scales are administered to the subjects. during the rehabilitation period, subjects received conventional physiotherapy.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Subjects > 18 years;
  • Both Sexs;
  • Knee or Hip Arthroplasty in the previous 3-4 days before admission;
  • Subjects with clinical stability at admission (Hemoglobin > 9 g/l).

排除标准

  • Fever at admission;
  • Any rheumatic or systemic diseases;
  • Previous surgery at the lower limbs (6 months before admission) or other arthroplasties at the lower limbs;
  • MiniMental State Examination < 24;
  • Other neurologic disorders.
  • For the healthy volunteers
  • Inclusion Criteria:
  • Subjects age-matched with the subjects in the hip and knee group.
  • Exclusion Criteria:
  • Any disorder that could negatively affect gait perfomance.

结局指标

主要结局

Change in Gait Variable Scores

时间窗: From Admission (T0) up to 15/21 days (discharge) (T1)

Change from Admission of Gait Variable Score untill 15/21 days (Discharge)

Change in gait cycle length

时间窗: From Admission (T0) up to 15/21 days (discharge) (T1)

Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

Change in gait cycle duration

时间窗: From Admission (T0) up to 15/21 days (discharge) (T1)

Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

Change in Gait Profile Score

时间窗: From Admission (T0) up to 15/21 days (discharge) (T1)

Change from Admission of Gait Profile Score untill 15/21 days (Discharge)

Change in gait speed

时间窗: From Admission (T0) up to 15/21 days (discharge) (T1)

Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

Change in step length

时间窗: From Admission (T0) up to 15/21 days (discharge) (T1)

Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

Change in stance phase duration

时间窗: From Admission (T0) up to 15/21 days (discharge) (T1)

Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

Change in swing phase duration

时间窗: From Admission (T0) up to 15/21 days (discharge) (T1)

Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

Change in single support phase duration

时间窗: From Admission (T0) up to 15/21 days (discharge) (T1)

Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

Change in Gai Deviation Index

时间窗: From Admission (T0) up to 15/21 days (discharge) (T1)

Change from Admission of Gait Deviation Index untill 15/21 days (Discharge)

Change in gait cadence

时间窗: From Admission (T0) up to 15/21 days (discharge) (T1)

Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

Change in double support phase duration

时间窗: From Admission (T0) up to 15/21 days (discharge) (T1)

Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

次要结局

  • Change in Modified Barthel Index(From Admission (T0) up to 15/21 days (discharge) (T1))
  • Change in Merlè D'Aubigne score(From Admission (T0) up to 15/21 days (discharge) (T1))
  • Change in International Knee Society score(From Admission (T0) up to 15/21 days (discharge) (T1))
  • Change in Numerical Pain Rating Scale(From Admission (T0) up to 15/21 days (discharge) (T1))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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The Effectiveness of Rehabilitation in Gait Recovery... | 临床试验