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临床试验/NCT06162858
NCT06162858招募中不适用

Reaching Motion by the Elderly During Functional Activities. A Comparison Beween a Healthy Control Group and Patients With a Reverse Shoulder Arthroplasty

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
IMU registration (3D kinematics upper limb)

研究概览

简要总结

Taking and moving objects is essential. When this becomes difficult, it affects daily functioning. This study aims to determine movement patterns, at the level of the shoulder, during different functional movements in elderly people aged 60 years and older. Movement patterns of people without shoulder problems and patients with a reverse shoulder prosthesis will be compared. These insights can contribute to improving functional rehabilitation in patients with a reverse shoulder prosthesis (RSA).

详细描述

This study aims to investigate how elderly people (60 years and older) without shoulder pain and patients with a reverse shoulder arthroplasty (60 years and older) perform functional reaching movements. Using IMUs (Inertial Measurement Units), the investigators want to look at mode of execution, relational positions of hand, elbow and shoulder in space, in relation to the trunk and each other, and any compensatory movements made by patients with a reverse shoulder arthroplasty.

At the time of testing, participants will first complete a series of questionnaires. These questionnaires will provide information about the daily functioning of all participants. The participants' shoulder strength will also be measured.

After applying the IMUs, the participant will first perform a maximal movement (active for participant) in 4 directions (forward and lateral lifting of arm, hand-to-neck , hand-to-back). Then the researcher will perform the same movements with the participant's arm (passive for participant). This will allow measurement of the maximum active and passive mobility of the shoulder. Next, the participant will be asked to place and take back a number of different objects (both in terms of size and weight) at predetermined heights.

The participants without shoulder pain will be tested once, the participants with a reverse shoulder arthroplasty we want to test 4 times. The participants without shoulder pain will be assigned to the control group. The participants with a reverse shoulder arthroplasty we want to test 4 times to monitor not only their movement pattern, but also any changes in this pattern .

The questionnaires, strength measurement and requested movements will be the same for both groups.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •60 years and older
  • •no shoulder pain + no diagnosis of shoulder problem
  • •primary reverse shoulder arthroplasty

排除标准

  • •younger than 60 years
  • •shoulder pain at moment of testing
  • •known shoulder problem ( incl. diagnosis)

研究组 & 干预措施

Healthy participants

Other

no shoulder pain no shoulder diagnosis 60 years and older

干预措施: IMU (Inertial Measurement Devices) (Other)

RSA participants

Other

primary reverse shoulder arthroplasty 60 years and older

干预措施: IMU (Inertial Measurement Devices) (Other)

结局指标

主要结局

IMU registration (3D kinematics upper limb)

时间窗: RSA group: 12 months post surgery

kinematic registration of performed exercises by all participants

IMU registration (3D kinematics upper limb)

时间窗: healthy control group: baseline

kinematic registration of performed exercises by all participants

IMU registration (3D kinematics upper limb)

时间窗: RSA group: 3 weeks post surgery

kinematic registration of performed exercises by all participants

IMU registration (3D kinematics upper limb)

时间窗: RSA group: 6 weeks post surgery

kinematic registration of performed exercises by all participants

IMU registration (3D kinematics upper limb)

时间窗: RSA group: 12 weeks post surgery

kinematic registration of performed exercises by all participants

IMU registration (3D kinematics upper limb)

时间窗: RSA group: 6 months post surgery

kinematic registration of performed exercises by all participants

次要结局

  • EQ5D5L(during procedure)
  • VAS-pain(during procedure)
  • AROM(during procedure)
  • Constant- Murley Score(during procedure)
  • PROM(during procedure)
  • SPADI_DV(during procedure)
  • strength(during procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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