Reaching Motion During Functional Activities

Healthy Clinical Trial

— REACHRSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06162858
• Other study ID #: ONZ-2023-0416
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: November 2023
• Source: University Hospital, Ghent
• Contact: Dominiek Vandenbosch, MSc
• Phone: +32 9 332 16 69
• Email: dominiek.vandenbosch[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Healthy
• Joint Diseases
• Shoulder Arthropathy Associated With Other Conditions

Intervention

Other:
• IMU (Inertial Measurement Devices)
Functional placing and reaching of objects of different weights on different heights

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent
Belgium	University Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AGE	specify age of participant	during procedure
Other	GENDER	specify age of participant	during procedure
Other	DOMINANCE	specify hand dominance of participant	during procedure
Other	height	specify participants height	during procedure
Other	weight	specify participants weight	during procedure
Primary	IMU registration (3D kinematics upper limb)	kinematic registration of performed exercises by all participants	healthy control group: baseline
Primary	IMU registration (3D kinematics upper limb)	kinematic registration of performed exercises by all participants	RSA group: 3 weeks post surgery
Primary	IMU registration (3D kinematics upper limb)	kinematic registration of performed exercises by all participants	RSA group: 6 weeks post surgery
Primary	IMU registration (3D kinematics upper limb)	kinematic registration of performed exercises by all participants	RSA group: 12 weeks post surgery
Primary	IMU registration (3D kinematics upper limb)	kinematic registration of performed exercises by all participants	RSA group: 6 months post surgery
Primary	IMU registration (3D kinematics upper limb)	kinematic registration of performed exercises by all participants	RSA group: 12 months post surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	VAS-pain	Pain is scored between 0 and 10. 0 = no pain, 10= worst possible pain	during procedure
Secondary	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
Secondary	PROM	passive range of motion for forward flexion and abduction; maximal pain free ROM; measured with the EasyAngle (Meloq AB Sweden)	during procedure
Secondary	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