NCT05881876

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

May 21, 2023

Last Update Submit

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

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

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: 34955294BACKGROUND
  • 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.

    PMID: 31918533BACKGROUND

Central Study Contacts

Seongeun Baek/Hangang Sacred Heart Hospital IRB

CONTACT

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