Contracture JointNCT05881876
Determining the Reliability and Validity of a New Method for Measuring Upper Extremity Joint Range of Motion in Burn Patients Using a Tracking System
An observational study of Contracture Joint, run by Hangang Sacred Heart Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Contracture Joint
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2023to 31 Dec 2023
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: who had developed joint contractures in the shoulder, elbow or wrist due to hypertrophic scars after thermal injury were enrolled in this study
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Contracture Joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 2 days
Secondary outcomes (1)
AMA evaluation
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start15 Jun 2023 (estimated)
- Primary completion25 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Contracture JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Hangang Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Young Joo, Hangang Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881876
- Sponsor's protocol ID
- HangangSHH-14
- Status last verified
- May 2023
- First submitted
- 21 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34955294Ahn 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.
PubMed 31918533Lee SY, Zheng YX, Seo CH, Cho YS, Seo J, Bae YD, Yoon J, Byun K, Joo SY. Determining the reliability and validity of a new method for measuring upper extremity joint range of motion in patients with burn injury using a tracking system. Clin Rehabil. 2026 Apr 21:2692155261432011. doi: 10.1177/02692155261432011. Online ahead of print.
PubMed 42012175
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Reliability and Validity of a New Method for Measuring Upper Extremity Joint Range of Motion in Burn Patients Using a Tracking System
- ClinicalTrials.gov ID
- NCT05881876
- Acronym / sponsor ID
- HangangSHH-14
- Conditions
- Contracture Joint
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hangang Sacred Heart HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 25 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- who had developed joint contractures in the shoulder, elbow or wrist due to hypertrophic scars after thermal injury were enrolled in this study
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 .
1 secondary outcome
AMA evaluation
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Background: PubMed 34955294Schouten 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.
- Background: PubMed 31918533Ahn 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.
- Derived from this study: PubMed 42012175Lee SY, Zheng YX, Seo CH, Cho YS, Seo J, Bae YD, Yoon J, Byun K, Joo SY. Determining the reliability and validity of a new method for measuring upper extremity joint range of motion in patients with burn injury using a tracking system. Clin Rehabil. 2026 Apr 21:2692155261432011. doi: 10.1177/02692155261432011. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Contracture Joint, run by Hangang Sacred Heart Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seongeun Baek/Hangang Sacred Heart Hospital IRB (82-2-2639-5900, tjddms1108@hallym.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
range of motion of joint (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05881876, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.