Shoulder Arthropathy Associated With Other ConditionsREACHRSANCT06162858
Reaching Motion During Functional Activities
A study testing IMU (Inertial Measurement Devices) in people with Shoulder Arthropathy Associated With Other Conditions and Healthy, run by University Hospital, Ghent at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Arthropathy Associated With Other Conditions, Healthy
- What is being tested?
- IMU (Inertial Measurement Devices)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesBelgium
- Study dates
- 15 Oct 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years and older
- no shoulder pain + no diagnosis of shoulder problem
- primary reverse shoulder arthroplasty
Who cannot join
- younger than 60 years
- shoulder pain at moment of testing
- known shoulder problem ( incl. diagnosis)
Trial locations and contacts
2 sites in 1 country.
Alexander Van Tongel, PhD contact
Belgium2 sites, 2 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Dominiek Vandenbosch, Msc, +32476439601, dominiek.vandenbosch@ugent.be
Alexander Van Tongel, PhD, alexander.vantongel@uzgent.be
- Recruiting
University Ghent
Ghent, 9000
Dominiek Vandenbosch, MSc, +32 9 332 16 69, dominiek.vandenbosch@ugent.be
Annelies Maenhout, Phd, annelies.maenhout@ugent.be
About this study
Official title: 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).
Read the 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)
- Being tested
- IMU (Inertial Measurement Devices)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMU (Inertial Measurement Devices)Other
Functional placing and reaching of objects of different weights on different heights
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Other | no shoulder pain no shoulder diagnosis 60 years and older Receives: Other: IMU (Inertial Measurement Devices) |
| RSA participants | Other | primary reverse shoulder arthroplasty 60 years and older Receives: Other: IMU (Inertial Measurement Devices) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMU registration (3D kinematics upper limb)
kinematic registration of performed exercises by all participants
Measured: healthy control group: baseline
IMU registration (3D kinematics upper limb)
kinematic registration of performed exercises by all participants
Measured: RSA group: 3 weeks post surgery
IMU registration (3D kinematics upper limb)
kinematic registration of performed exercises by all participants
Measured: RSA group: 6 weeks post surgery
IMU registration (3D kinematics upper limb)
kinematic registration of performed exercises by all participants
Measured: RSA group: 12 weeks post surgery
IMU registration (3D kinematics upper limb)
kinematic registration of performed exercises by all participants
Measured: RSA group: 6 months post surgery
IMU registration (3D kinematics upper limb)
kinematic registration of performed exercises by all participants
Measured: RSA group: 12 months post surgery
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: during procedure
VAS-pain
Pain is scored between 0 and 10. 0 = no pain, 10= worst possible pain
Measured: 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
Measured: during procedure
PROM
passive range of motion for forward flexion and abduction
- maximal pain free ROM
- measured with the EasyAngle (Meloq AB Sweden)
Measured: 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
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start15 Oct 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Arthropathy Associated With Other ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Alexander Van Tongel, PhD, Principal investigator, University Hospital Ghent, University GhentAnn Cools, PhD, Study chair, University GhentAnnelies Maenhout, PhD, Study chair, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162858
- Sponsor's protocol ID
- ONZ-2023-0416
- Acronym
- REACHRSA
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching Motion by the Elderly During Functional Activities. A Comparison Beween a Healthy Control Group and Patients With a Reverse Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT06162858
- Acronym / sponsor ID
- REACHRSA / ONZ-2023-0416
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Other | Other: IMU (Inertial Measurement Devices)no shoulder pain no shoulder diagnosis 60 years and older |
| RSA participants | Other | Other: IMU (Inertial Measurement Devices)primary reverse shoulder arthroplasty 60 years and older |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 years and older
- no shoulder pain + no diagnosis of shoulder problem
- primary reverse shoulder arthroplasty
Key exclusion criteria (3 listed)
- younger than 60 years
- shoulder pain at moment of testing
- known shoulder problem ( incl. diagnosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMU (Inertial Measurement Devices)Functional placing and reaching of objects of different weights on different heights | Other | Healthy participants, RSA participants |
Primary outcome
IMU registration (3D kinematics upper limb)
Time frame: healthy control group: baseline
kinematic registration of performed exercises by all participants
IMU registration (3D kinematics upper limb)
Time frame: RSA group: 3 weeks post surgery
kinematic registration of performed exercises by all participants
IMU registration (3D kinematics upper limb)
Time frame: RSA group: 6 weeks post surgery
kinematic registration of performed exercises by all participants
IMU registration (3D kinematics upper limb)
Time frame: RSA group: 12 weeks post surgery
kinematic registration of performed exercises by all participants
IMU registration (3D kinematics upper limb)
Time frame: RSA group: 6 months post surgery
kinematic registration of performed exercises by all participants
IMU registration (3D kinematics upper limb)
Time frame: RSA group: 12 months post surgery
kinematic registration of performed exercises by all participants
7 secondary outcomes
SPADI_DV
Time frame: during procedure
Constant- Murley Score
Time frame: during procedure
EQ5D5L
Time frame: during procedure
VAS-pain
Time frame: during procedure
AROM
Time frame: during procedure
PROM
Time frame: during procedure
strength
Time frame: during procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Van Tongel, PhD contact
Alexander Van Tongel, PhD principal investigator
University Hospital Ghent, University Ghent
Ann Cools, PhD study chair
University Ghent
Annelies Maenhout, PhD study chair
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMU (Inertial Measurement Devices) in people with Shoulder Arthropathy Associated With Other Conditions and Healthy, run by University Hospital, Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominiek Vandenbosch, MSc (+32 9 332 16 69, dominiek.vandenbosch@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IMU registration (3D kinematics upper limb) (time frame: healthy control group: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.