NCT06162858

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Oct 2023Sep 2026

Study Start

First participant enrolled

October 15, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

December 8, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

November 6, 2023

Last Update Submit

November 29, 2023

Conditions

Shoulder Arthropathy Associated With Other ConditionsHealthy

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (7)

  • SPADI_DV

    during procedure

  • Constant- Murley Score

    during procedure

  • EQ5D5L

    during procedure

  • VAS-pain

    during procedure

  • AROM

    during procedure

  • +2 more secondary outcomes

Other Outcomes (5)

  • AGE

    during procedure

  • GENDER

    during procedure

  • DOMINANCE

    during procedure

  • +2 more other outcomes

Study Arms (2)

Healthy participants

OTHER

no shoulder pain no shoulder diagnosis 60 years and older

Other: IMU (Inertial Measurement Devices)

RSA participants

OTHER

primary reverse shoulder arthroplasty 60 years and older

Other: IMU (Inertial Measurement Devices)

Interventions

IMU (Inertial Measurement Devices)OTHER

Functional placing and reaching of objects of different weights on different heights

Healthy participantsRSA participants

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

University Ghent

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Interventions

24,25-oxidolanosterol

Study Officials

  • Alexander Van Tongel, PhD

    University Hospital Ghent, University Ghent

    PRINCIPAL INVESTIGATOR

  • Ann Cools, PhD

    University Ghent

    STUDY CHAIR

  • Annelies Maenhout, PhD

    University Ghent

    STUDY CHAIR

Central Study Contacts

Dominiek Vandenbosch, MSc

CONTACT

+32 9 332 16 69dominiek.vandenbosch@ugent.be

Alexander Van Tongel, PhD

CONTACT

alexander.vantongel@uzgent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2023

First Posted

December 8, 2023

Study Start

October 15, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

December 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)