Reaching Motion During Functional Activities (REACHRSA)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Healthy; Shoulder Arthropathy Associated With Other Conditions
• Intervention / Treatment: Other: IMU (Inertial Measurement Devices)

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominiek Vandenbosch, MSc; Phone Number: +32 9 332 16 69; Email: dominiek.vandenbosch@ugent.be
• Study Contact Backup: Name: Alexander Van Tongel, PhD; Email: alexander.vantongel@uzgent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
    • Contact: Alexander Van Tongel, PhD; Email: alexander.vantongel@uzgent.be
    • Contact: Dominiek Vandenbosch, Msc; Phone Number: +32476439601; Email: dominiek.vandenbosch@ugent.be
  • Ghent, Belgium, 9000
    • Recruiting
    • University Ghent
    • Contact: Dominiek Vandenbosch, MSc; Phone Number: +32 9 332 16 69; Email: dominiek.vandenbosch@ugent.be
    • Contact: Annelies Maenhout, Phd; Email: annelies.maenhout@ugent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy participants; no shoulder pain no shoulder diagnosis 60 years and older	Other: IMU (Inertial Measurement Devices); Functional placing and reaching of objects of different weights on different heights
Other: RSA participants; primary reverse shoulder arthroplasty 60 years and older	Other: IMU (Inertial Measurement Devices); Functional placing and reaching of objects of different weights on different heights

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IMU registration (3D kinematics upper limb)	kinematic registration of performed exercises by all participants	healthy control group: baseline
IMU registration (3D kinematics upper limb)	kinematic registration of performed exercises by all participants	RSA group: 3 weeks post surgery
IMU registration (3D kinematics upper limb)	kinematic registration of performed exercises by all participants	RSA group: 6 weeks post surgery
IMU registration (3D kinematics upper limb)	kinematic registration of performed exercises by all participants	RSA group: 12 weeks post surgery
IMU registration (3D kinematics upper limb)	kinematic registration of performed exercises by all participants	RSA group: 6 months post surgery
IMU registration (3D kinematics upper limb)	kinematic registration of performed exercises by all participants	RSA group: 12 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPADI_DV	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	during procedure
Constant- Murley Score	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	during procedure
EQ5D5L	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	during procedure
VAS-pain	Pain is scored between 0 and 10. 0 = no pain, 10= worst possible pain	during procedure
AROM	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	during procedure
PROM	passive range of motion for forward flexion and abduction; maximal pain free ROM; measured with the EasyAngle (Meloq AB Sweden)	during procedure
strength	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	during procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
AGE	specify age of participant	during procedure
GENDER	specify age of participant	during procedure
DOMINANCE	specify hand dominance of participant	during procedure
height	specify participants height	during procedure
weight	specify participants weight	during procedure

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent
• Investigators: Study Chair: Ann Cools, PhD, University Ghent; Principal Investigator: Alexander Van Tongel, PhD, University Hospital Ghent, University Ghent; Study Chair: Annelies Maenhout, PhD, University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: ONZ-2023-0416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No