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临床试验/NCT05188560
NCT05188560已完成不适用

Efficacy of a Single Preoperative Administration of Action Observation Therapy Associated With Motor Imagery in Patients Undergoing Total Hip Arthroplasty.

Istituto Clinico Humanitas2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Changes in functional mobility using Timed Up and Go test (TUG).

研究概览

简要总结

Action Observation Therapy (AOT) and Motor Imagery (MI) are two rehabilitation approaches based on Mirror Neuron System (MNS). The MNS refers to a series of neurons able to activate both when one observes an action being performed or when one physically performs the action themselves. Previous studies reported that functional recovery is facilitated by asking patient observing videos with motor content (AOT) and after imagining (MI) the gestures observed. These rehabilitative apporach have been used in particular to promote functional recovery in patients with neuromotor problems, in particular in patients with stroke. To date, few studies have investigated the effectiveness of this therapeutic approach in functional recovery after orthopedic surgery and none of these applied AOT and MI in a single pre-operative session. The objective of the study is to verify whether a single administration consisting of two pre-operative sessions of AOT associated with MI can lead to an improvement of functional recovery in hip arthroplasty patients.

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
Single (Outcomes Assessor)

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

  • Total hip arthroplasty (THA) monolateral, first implant
  • Locomotor autonomy with or without aids before surgery
  • BMI (regular, overweight, Grade I obesity)
  • No complications in surgery
  • Orthopaedic prescription of tolerance load on the limb
  • Autonomy with aids within the third post-operative day

排除标准

  • Previous total hip replacement on contralateral hip
  • Dementia or other conditions affecting patient's collaboration
  • Unresolved clinical complications in the first two post-operative days
  • Neurological, musculoskeletal or other disorders able to impact on functional recovery
  • Visual or auditory deficits
  • Total or partial revisions of THA
  • Patients assigned to different groups hospitalized in the same room

结局指标

主要结局

Changes in functional mobility using Timed Up and Go test (TUG).

时间窗: Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.

The primary outcome is to investigate whether a single administration consisting of two sessions of AOT and MI performed the day before the total hip arthroplasty may impact on functional recovery in the immediate post-operative period. Functional mobility will be evaluated with Timed Up and Go test.

次要结局

  • Changes in maximum gait speed(Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.)
  • Changes in pain using Visual Analogue Scale (VAS)(Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (2)

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