Determining the Reliability and Validity of a New Method for Measuring Upper Extremity Joint Range of Motion in Burn Patients Using a Tracking System
1 other identifier
observational
50
0 countries
N/A
Brief Summary
In burn patients, joint contracture is a common complication caused by hypertrophic scars, necessitating accurate evaluation and diagnosis of the degree of disability and functional deterioration. A standard goniometer based on the American Medical Association (AMA) guidelines for measuring joint range of motion (ROM) is the gold standard for evaluating musculoskeletal diseases. However, the handheld goniometer is highly dependent on the skill and experience of the measurer. Recently, a marker-based system for accurate ROM measurement has been demonstrated in clinical evaluation. This study investigated the reliability and validity of the marker-based system for evaluation of joint ROM in burn patients. Inclusion criteria were as follows: male or female patients between 18 and 75 years of age, partial or full-thickness burns that healed spontaneously or required skin grafting, and limited joint ROM in the upper extremities caused by burns. Exclusion criteria were limited joint ROM due to severe osteoarthritis or rheumatoid arthritis, congenital defects, structural disease, amputation, central or peripheral nervous system injuries, difficulty in voluntary decision-making due to cognitive impairment, or a history of orthopaedic surgery due to fracture. The experimentals tried to compare the validity and reliability of a marker-based system and AMA methods for the burn patient with joint contracture of upper extremities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2023
Shorter than P25 for all trials
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
First Submitted
Initial submission to the registry
May 21, 2023
CompletedFirst Posted
Study publicly available on registry
May 31, 2023
CompletedStudy Start
First participant enrolled
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMay 31, 2023
May 1, 2023
6 months
May 21, 2023
May 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
range of motion of joint
For ROM evaluation in upper extremities, 22 reflective markers were attached to the patient's body before measurement and markers were tracked using eight infrared cameras. Prior to the test, a static calibration test was performed in a neutral position. A skeleton model was obtained directly from the Motive2.1 (the unified software platform of OptiTrack®) for the data gathered by the OptiTrack® system (NaturalPoint, Inc., Corvallis, OR, USA).The ROM of the shoulder, elbow, and wrist was measured sequentially using a dynamic view. The marker trajectories allowed estimation of the joint centres and definition (Figure 1). The joint centres were calculated from optical motion capture data, according to the definitions of Visual3D (C-Motion, Inc., Germantown, MD, USA), a widely used software tool for 3D biomechanical research .
2 days
Secondary Outcomes (1)
AMA evaluation
2 days
Study Arms (1)
burn groups
Inclusion criteria were as follows: male or female patients between 18 and 75 years of age, partial or full-thickness burns that healed spontaneously or required skin grafting, and limited joint ROM in the upper extremities caused by burns.
Eligibility Criteria
who had developed joint contractures in the shoulder, elbow or wrist due to hypertrophic scars after thermal injury were enrolled in this study
You may qualify if:
- male or female patients
- ages between 18 and 75 years of age
- partial or full-thickness burns that healed spontaneously or required skin grafting
- limited joint ROM in the upper extremities caused by burns.
You may not qualify if:
- limited joint ROM due to severe osteoarthritis or rheumatoid arthritis
- congenital defects, structural disease, amputation
- central or peripheral nervous system injuries
- difficulty in voluntary decision-making due to cognitive impairment
- a history of orthopaedic surgery due to fracture.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Schouten HJ, Nieuwenhuis MK, van Baar ME, van der Schans CP, Niemeijer AS, van Zuijlen PPM. The degree of joint range of motion limitations after burn injuries during recovery. Burns. 2022 Mar;48(2):309-318. doi: 10.1016/j.burns.2021.01.003. Epub 2021 Jan 22.
PMID: 34955294BACKGROUNDAhn SY, Ko H, Yoon JO, Cho SU, Park JH, Cho KH. Determining the Reliability of a New Method for Measuring Joint Range of Motion Through a Randomized Controlled Trial. Ann Rehabil Med. 2019 Dec;43(6):707-719. doi: 10.5535/arm.2019.43.6.707. Epub 2019 Dec 31.
PMID: 31918533BACKGROUND
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Hangang Sacred Heart Hospital
Study Record Dates
First Submitted
May 21, 2023
First Posted
May 31, 2023
Study Start
June 15, 2023
Primary Completion
December 25, 2023
Study Completion
December 31, 2023
Last Updated
May 31, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share