Reaching Motion During Functional Activities

Not Applicable

Recruiting

• Conditions: Healthy; Shoulder Arthropathy Associated With Other Conditions
• Interventions: Other: IMU (Inertial Measurement Devices)

• Registration Number: NCT06162858
• Lead Sponsor: University Hospital, Ghent

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)

Study Timeline

• Study Start: 2023-10-15
• Status Verified: 2023-11
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Study First Posted: 2023-12-08
• Last Update Posted: 2023-12-08
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RSA participants	IMU (Inertial Measurement Devices)	primary reverse shoulder arthroplasty 60 years and older
Healthy participants	IMU (Inertial Measurement Devices)	no shoulder pain no shoulder diagnosis 60 years and older

Primary Outcome Measures

Name	Time	Method
IMU registration (3D kinematics upper limb)	RSA group: 12 months post surgery	kinematic registration of performed exercises by all participants

Secondary Outcome Measures

Name	Time	Method
SPADI_DV	during procedure	Content: 5 questions for the subscale pain and 8 questions for the disability subscale.; Scoring: numeric rating scale from 1 to 10, with a maximum of 130. The total score is the sum of the sub-scores.; Interpretation: The higher the score the more pain and disability. The lower the score, the better patients perceive their shoulder
EQ5D5L	during procedure	Content: 5 questions + EQ-5D VAS for general health. Scoring: 5-response scale (from 'no problems' to 'extreme problems') + VAS percentage between 0 (worst imaginable health state) and 100 (best imaginable health state).; Interpretation: VAS score for general health indicates how a patient perceives his general health, Other questions are descriptive for problems in mobility, self-care, usual activities, pain/ discomfort, anxiety/depression
VAS-pain	during procedure	Pain is scored between 0 and 10. 0 = no pain, 10= worst possible pain
AROM	during procedure	active range of motion for forward flexion, abduction, hand-to-neck, hand-to-back forward flexion and abduction with extended elbow, functional internal and external rotation in standing position.; * maximal pain free ROM; * forward flexion and abduction with extended elbow: measured with the EasyAngle (Meloq AB Sweden); * hand-to-back and hand-to-neck test : scored as in Constant-Murley Score
Constant- Murley Score	during procedure	Content: partially clinical (65 points) and partially PROM (35 points) assessed.; Scoring: The formula to calculate the total score is:" pain (0-15) + ADL (4x (0-5) = 0-20) + mobility (4 x (0-10) = 0-40); + strength (0 -25)". Strength will be measured with the arm elevated to 90 ° in the scapular plane using an IDOmeter.; Interpretation: 0-55 points = bad, 56-70 points = mediocre, 71-85 points = good, 86-100 points = excellent score
PROM	during procedure	passive range of motion for forward flexion and abduction; * maximal pain free ROM; * measured with the EasyAngle (Meloq AB Sweden)
strength	during procedure	strength will be measured for forward flexion in 0° elevation and in 90° elevation with the EasyForce.; FF at 0° elevation: participants will sit on a chair without backrest, both feet on the ground. Arm in neutral rotation, hand in a fist, thumb facing upward FF at 90° elevation: participants will stand, the arm with extended elbow held at 90° elevation (FF). Hand in a fist, thumb facing upward

Trial Locations

Locations (2)

University Ghent; 🇧🇪 Ghent, Belgium

Ghent University Hospital; 🇧🇪 Ghent, Belgium