The Impact of Shoulder Immobilization by Orthoses on Human Joint Biomechanics and Inter-joint Coordination

NCT07659054 | Recruiting

• 1 other identifier: 202407128RINC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Shoulder joint orthoses are commonly used for patients with shoulder disorders to stabilize and protect shoulder joint after injury or surgery. These devices maintain proper anatomical alignment of the shoulder joint and surrounding soft tissues, reducing pain, facilitating proper recovery, and preventing further injury. Commonly used shoulder orthoses include shoulder sling, abduction brace, and figure-of-eight shoulder brace. The appropriate orthosis is selected based on patient's specific clinical needs, and it should be worn for an appropriate duration to avoid over or inadequate shoulder immobilization. When patients wear shoulder orthoses during daily activities, such as sit-to-stand, level walking, climbing stairs, or overcoming obstacles of a certain height, the immobilized shoulder reduces reciprocal arm swing, altering body's balance mechanism and potentially increasing the risk of falls. Different shoulder orthoses with various shoulder position affect human motor coordination and balance to varying degrees. Therefore, assessing the changes in body movements caused by shoulder immobilization with orthoses can provide crucial clinical information to aid in clinical decision-making. This study utilizes stereophotogrammetry to measure and analyze subjects' motion changes while their shoulders are immobilized with orthoses. It aims to understand the biomechanical changes when subjects participate in static balance tests and dynamic activities. Through corresponding biomechanical analyses, including kinematics, dynamics, and joint coordination, the study seeks to understand the extent of the impact of shoulder orthoses on human movements. This information would serve as important reference data for subsequent clinical decisions regarding whether to use orthoses or not, the duration of use, and the suitability of the orthoses for patients of different ages.

Conditions

Motion Analysis; Biomechanical Parameters

Keywords

Motion analysis; stereophotogrammetry; Biomechanical analysis; Joint coordination

Outcome Measures

Primary Outcomes (2)

• Crossing speed in m/s

  VICON system would record the distance of body movement while participants crossing the obstacle, and crossing speed would be calculate as Distance divided by time (m/s)

  From enrollment to 6 months follow-up

• Toe-obstacle distance in mm and joint angles in degree(°)

  VICON system would record the distance between big toe and obstacle, recorded as toe clearance in mm. Also the position of body segments would be recorded to calculate hip, knee and ankle joints, recorded as degree in °.

  From enrollment to 6 months follow-up

Secondary Outcomes (1)

• Change of joint angle in degree(°)

  From enrollment to 6 months follow-up

Study Arms (1)

Joint immobilization by sling

EXPERIMENTAL

Participants would wear a simple shoulder sling to immobilize unilateral side of shoulder joint.

Device: Shoulder immobilization by sling

Interventions

Shoulder immobilization by sling DEVICE

Unilateral shoulder joint immobilized by simple shoulder sling

Joint immobilization by sling

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with mid-shaft clavicle fractures aged between 20-65 years old. Free from any neuromusculoskeletal disease of the lower limbs and the lower back except for the clavicle fractures
• Patients with acute shoulder rotators severe rupture aged between 20-65 years old. Free from any neuromusculoskeletal disease of the lower limbs and the lower back except for the shoulder rotators rupture.
• Healthy controls with age, height, and weight matched to patient groups. Free from any neuromusculoskeletal disease of the lower limbs and the lower back.

You may not qualify if:

• Individuals who have other gait altering disorders.
• Age below 20 or above 65.
• If a female participant is pregnant, she will be excluded until recovery from pregnancy.
• If he/she rejects to give his/her informed consent.
• Has any neuromusculoskeletal diseases, orthopedic or medical diseases other than shoulder injuries resulting in difficulty of motion and ambulation.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100229, Taiwan

RECRUITING

Related Publications (6)

• Tung JY, Gage WH, Poupart P, McIlroy WE. Upper limb contributions to frontal plane balance control in rollator-assisted walking. Assist Technol. 2014 Spring;26(1):15-21; quiz 22-3. doi: 10.1080/10400435.2013.789456.

  PMID: 24800450 BACKGROUND

• Bostrom KJ, Dirksen T, Zentgraf K, Wagner H. The Contribution of Upper Body Movements to Dynamic Balance Regulation during Challenged Locomotion. Front Hum Neurosci. 2018 Jan 26;12:8. doi: 10.3389/fnhum.2018.00008. eCollection 2018.

  PMID: 29434544 BACKGROUND

• Forero J, Misiaszek JE. Balance-corrective responses to unexpected perturbations at the arms during treadmill walking. J Neurophysiol. 2014 Oct 1;112(7):1790-800. doi: 10.1152/jn.00719.2013. Epub 2014 Jul 16.

  PMID: 25031255 BACKGROUND

• Marigold DS, Patla AE. Adapting locomotion to different surface compliances: neuromuscular responses and changes in movement dynamics. J Neurophysiol. 2005 Sep;94(3):1733-50. doi: 10.1152/jn.00019.2005. Epub 2005 May 11.

  PMID: 15888535 BACKGROUND

• Horak, F.B. and J.M. Macpherson, Postural Orientation and Equilibrium. Comprehensive Physiology, 2011: p. 255-292.

  BACKGROUND

• Mohebbi A, Amiri P, Kearney RE. Identification of human balance control responses to visual inputs using virtual reality. J Neurophysiol. 2022 Apr 1;127(4):1159-1170. doi: 10.1152/jn.00283.2021. Epub 2022 Mar 30.

  PMID: 35353629 BACKGROUND

Study Officials

• YAO-CHANG LO, M.D.

  National Taiwan University Hospital

  STUDY DIRECTOR

Central Study Contacts

YAO-CHANG LO, M.D.

CONTACT

+886 987-158-535; jeanoeno@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: June 22, 2026
• Study Start: November 27, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 22, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)