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临床试验/NCT05561218
NCT05561218尚未招募不适用

Dispersion of Shoulder Helical Axes Before and After Physical Therapy in Patients With Shoulder Instability

Istituto Clinico Humanitas0 个研究点目标入组 25 人开始时间: 2022年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
主要终点
Helical Axes (HAs) dispersion analysis

研究概览

简要总结

Shoulder instability is associated with neuromuscular control alterations. Helical Axes (HAs) dispersion is influenced by joint morphology and neuromuscular control and its analysis can be used to quantify the Center of Rotation (CoR) displacement.

The aim of the study is to evaluate the effects of an exercise-based training on shoulder HAs dispersion during upper limb movements in patients with shoulder instability and to assess the association between shoulder arthrokinematics and instability-related symptoms.

25 patients with shoulder instability and 25 healthy subjects (aged between 18 and 50) will be enrolled. The HAs dispersion will be assessed during the performance of two upper limb task, shoulder flexion and shoulder rotation. Kinematics will be recorded by an optoelectronic system and HAs dispersion was computed using Mean Distance (MD) and Mean Angle (MA).

Pain and functional impairments will be assesed through the DASH scale, NRS scale, simple shoulder test (SST). Quality of life will be assessed with SF-12 scale.

Outcomes measures will be evaluated at the enrolment (T0), after one week (T1), after 12 weeks (T2) and after one month (T3). Between T1 and T2 patients perform a 12 weeks home-based exercise protocol and 12 outpatient physical therapy sessions.

详细描述

This will be a single center, observational study that will be conducted in Humanitas Research Hospital.

Patients with symptomatic shoulder instability be enrolled. An orthopaedic surgeon will confirm the diagnosis and recruit patient.

Age-matched heathy subjects, without history of shoulder pain or trauma in the last year, will be enrolled in the study.

Patients will perform a 12 weeks home exercise protocol (5 sessions of 15-20 minutes per week). The exercise-based treatment will be in line with the current literature and will focus on gaining neuromuscular control in different biomechanical contexts.

The home-based training will be divided in 5 different stages. In line with previous studies, the first phase will comprise isometric contractions that aim to the activation of the shoulder muscles and enhance their synergy. The second phase will include closed kinetic chain exercises to enhance physiological neuromuscular activation and shoulder functional stability, as previous studies suggested. The third phase will be a progression of phase 2 since it will use more challenging closed kinetic chain exercises .During phase four, patient will do closed kinetic chain exercises and low-load open kinetic chain exercises. During the fifth phase will include open kinetic chain and task-oriented exercises. Patients will attend one outpatient physical therapy session every week supervised by a physical therapist, who will show the exercises of the following week. Patient will also have a leaflet that will describe in detail each exercise.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 18 and 50 years
  • •Positivity to (at least) one of the three tests described in literature to asses multidirectional shoulder instability: sulcus sign, drawer test and apprehension test
  • •First episode of glenohumeral dislocation or subluxation treated with assisted reduction
  • •Presence of anatomical damage compatible with conservative treatment
  • •Presence of pain or apprehension in the last month

排除标准

  • •Subjects requiring surgical glenohumeral stabilization
  • •History of shoulder surgery
  • •Medically unstable subjects who, at the time of inclusion, have a neurological, internal or musculoskeletal disease that could affect functional or motor recovery

结局指标

主要结局

Helical Axes (HAs) dispersion analysis

时间窗: At baseline, after 1 week, after 12 weeks of training and at 1 month after the training end.

Changes in HAs dispersion to quantify the displacement of Center of Rotation during upper limb movements was quantified through parameters of MD and MA, which represent HAs displacement and orientation. HAs analysis will be performed through an optoelectronic system (BTS SMART-DX, Spa), consisting of 8 optical cameras and retroreflective markers.

次要结局

  • Short form - 12 items (12- best outcome, 57 worst outcome)(At baseline, after 12 weeks of training and at 1 month after the training end.)
  • Disability Arm Shoulder Hand (0- best outcome, 100 worst outcome)(At baseline, after 12 weeks of training and at 1 month after the training end.)
  • Simple shoulder test (0- worst outcome, 12 best outcome)(At baseline, after 12 weeks of training and at 1 month after the training end.)
  • Numeric pain rating scale (0- best outcome, 100 worst outcome)(At baseline, after 12 weeks of training and at 1 month after the training end.)

研究者

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

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