Clinical trial NCT06162858: Reaching Motion During Functional Activities
Official title: Reaching Motion by the Elderly During Functional Activities. A Comparison Beween a Healthy Control Group and Patients With a Reverse Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Arthropathy Associated With Other Conditions
Healthy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2023-12-08
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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).

Detailed description: 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.

Analysis of these movements will provide us with insights that can help improve the functional rehabilitation of patients with a reverse shoulder prosthesis.

All participants with a reverse shoulder arthroplasty will be recruited at UZ, participants without shoulder pain will be recruited through different channels (these are not patients)

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: IMU registration (3D kinematics upper limb)
timeFrame: healthy control group: baseline
measure: IMU registration (3D kinematics upper limb)
timeFrame: RSA group: 3 weeks post surgery
measure: IMU registration (3D kinematics upper limb)
timeFrame: RSA group: 6 weeks post surgery
measure: IMU registration (3D kinematics upper limb)
timeFrame: RSA group: 12 weeks post surgery
measure: IMU registration (3D kinematics upper limb)
timeFrame: RSA group: 6 months post surgery
measure: IMU registration (3D kinematics upper limb)
timeFrame: RSA group: 12 months post surgery
Secondary outcomes:
measure: SPADI_DV
timeFrame: during procedure
measure: Constant- Murley Score
timeFrame: during procedure
measure: EQ5D5L
timeFrame: during procedure
measure: VAS-pain
timeFrame: during procedure
measure: AROM
timeFrame: during procedure
measure: PROM
timeFrame: during procedure
measure: strength
timeFrame: during procedure
Other outcomes:
measure: AGE
timeFrame: during procedure
measure: GENDER
timeFrame: during procedure
measure: DOMINANCE
timeFrame: during procedure
measure: height
timeFrame: during procedure
measure: weight
timeFrame: during procedure
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Ghent
country: Belgium
facility: University Ghent
Study officials:
affiliation: University Hospital Ghent, University Ghent
name: Alexander Van Tongel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Ann Cools, PhD
role: STUDY_CHAIR
affiliation: University Ghent
name: Annelies Maenhout, PhD
role: STUDY_CHAIR
References: