- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05881876
Determining the Reliability and Validity of a New Method for Measuring Upper Extremity Joint Range of Motion in Burn Patients Using a Tracking System
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.
Study Overview
Status
Conditions
Detailed Description
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.
After three familiarisation trials for ROM measurement, the evaluation procedure was initiated on the participant's dominant side. A standard goniometer was used to measure ROM and increments were marked. The measurement position was the same as that used in the standard Korean range of motion protocol (KRSP). One examiner measured aROM for flexion, extension, abduction, adduction, external rotation, and internal rotation at a neutral position using a stainless-steel goniometer (JAMAR Co., Pakistan). The aROM was measured under the instruction that the subjects should move their arms as far as possible.
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. 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.
After evaluating the ROM of the upper extremity joint using a goniometer and optical motion capture system (session 1), re-measurement was performed 2 days later (session 2). Markers were positioned by the same observer in both sessions for all the participants.
All statistical analyses were performed using SPSS version 23 (IBM Corp., Armonk, NY, USA). The mean ROM and standard deviation were calculated. An independent t-test was used to compare inter-method differences. For intra-rater reliability, two tests were compared for each measurement. Relative reliability was assessed using the intraclass correlation coefficient (ICC) and ICC interpretation was based on the Fleiss guidelines. Statistical significance was set as P < 0.05.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Seongeun Baek/Hangang Sacred Heart Hospital IRB
- Phone Number: 82-2-2639-5900
- Email: tjddms1108@hallym.or.kr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
range of motion of joint
Time Frame: 2 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AMA evaluation
Time Frame: 2 days
|
A standard goniometer was used to measure ROM and increments were marked.
The measurement position was the same as that used in the standard Korean range of motion protocol (KRSP).
One examiner measured aROM for flexion, extension, abduction, adduction, external rotation, and internal rotation at a neutral position using a stainless-steel goniometer (JAMAR Co., Pakistan).
The aROM was measured under the instruction that the subjects should move their arms as far as possible.
|
2 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- Ahn 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HangangSHH-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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