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NCT Number: NCT06162858

Reaching Motion During Functional Activities

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).

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Key information

Conditions

Shoulder Arthropathy Associated With Other Conditions Healthy

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital, Ghent, Belgium

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About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

IMU (Inertial Measurement Devices)

Other

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

Primary outcomes

  1. IMU registration (3D kinematics upper limb)

    Time frame: healthy control group: baseline

    kinematic registration of performed exercises by all participants

  2. IMU registration (3D kinematics upper limb)

    Time frame: RSA group: 3 weeks post surgery

    kinematic registration of performed exercises by all participants

  3. IMU registration (3D kinematics upper limb)

    Time frame: RSA group: 6 weeks post surgery

    kinematic registration of performed exercises by all participants

  4. IMU registration (3D kinematics upper limb)

    Time frame: RSA group: 12 weeks post surgery

    kinematic registration of performed exercises by all participants

  5. IMU registration (3D kinematics upper limb)

    Time frame: RSA group: 6 months post surgery

    kinematic registration of performed exercises by all participants

  6. IMU registration (3D kinematics upper limb)

    Time frame: RSA group: 12 months post surgery

    kinematic registration of performed exercises by all participants

Secondary outcomes

  1. SPADI_DV

    Time frame: 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

  2. Constant- Murley Score

    Time frame: 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

  3. EQ5D5L

    Time frame: 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

  4. VAS-pain

    Time frame: during procedure

    Pain is scored between 0 and 10. 0 = no pain, 10= worst possible pain

  5. AROM

    Time frame: 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

  6. PROM

    Time frame: during procedure

    passive range of motion for forward flexion and abduction

    • maximal pain free ROM
    • measured with the EasyAngle (Meloq AB Sweden)

  7. strength

    Time frame: 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

Other outcomes

  1. AGE

    Time frame: during procedure

    specify age of participant

  2. GENDER

    Time frame: during procedure

    specify age of participant

  3. DOMINANCE

    Time frame: during procedure

    specify hand dominance of participant

  4. height

    Time frame: during procedure

    specify participants height

  5. weight

    Time frame: during procedure

    specify participants weight

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Van Tongel, PhD

CONTACT

[email protected]

Dominiek Vandenbosch, MSc

CONTACT

[email protected]

+32 9 332 16 69

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study title

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

Acronym: REACHRSA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2023
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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