Changes in Function of the Upper Limb With Physiotherapy

January 22, 2025 updated by: Brigita Siparyte-Sinkeviciene, Lithuanian University of Health Sciences

Changes in Function of the Upper Limb With Physiotherapy for Acute Burns: a Pilot Study

This paper describes a pilot clinical study designed to compare changes in ROM, muscle strength and functional recovery of the upper limb during the inpatient treatment period of burn injury.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Patients with burns can face challenges throughout their recovery, including contractures and a reduced range of motion (ROM) in the upper limb (UL), upper and lower limb impairment. Restoring range of motion, muscle strength, and mobility is essential to reduce scarring formation and contractures. The study included 17 patients with unilateral or bilateral superficial, deep partial and full thickness burns to the upper limbs, with or without burns to the upper body, covering 10% or more of the total body surface area

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Lithuania
      • Kaunas, Lithuania
        • Recruiting
        • Brigita Siparytė-Sinkevičienė
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients were invited to participate in the study when they came to the Department of Plastic and Reconstructive Surgery, the Kaunas Clinics, Lithuanian University of Health Sciences, for treatment of burns to the upper limb(s) or upper body. Data for this analysis were collected in 2020-2022.

Description

Inclusion Criteria:

  • patients aged 18-69 years
  • had burns on the upper limb(s) with or without burns on the upper body
  • burns involving ≥ 10% total body surface area (TBSA) with the presence of deep partial thickness or full thickness burns
  • who agreed to take part in the study

Exclusion Criteria:

  • inability to perform or understand tests
  • other injuries (fractures, brain injury)
  • central and peripheral nervous system disorders
  • amputation
  • with burns on the head, hands, feet, and genital area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Upper limb range of motion
Time Frame: Day 0, 7,14,21, 28, 35, more 35 days
A range of motion assessment evaluates the mobility of the injured joint and assesses the limitations of the range of motion.
Day 0, 7,14,21, 28, 35, more 35 days
Upper limb muscle strength
Time Frame: Day 0,14,35, more than 35 days
Assessing muscle strength helps determine how much muscle strength will be lost as a patient heals from a burn injury.
Day 0,14,35, more than 35 days
Pain intensity
Time Frame: Day 0, 7,14,21, 28, 35, more than 35 days
The pain rate scale assesses the intensity of pain. A higher score indicates a higher level of pain.
Day 0, 7,14,21, 28, 35, more than 35 days
Activities of daily living
Time Frame: Day 0,14,35, more than 35 days
Assessment of daily activity assesses the limitations of your daily activities. Higher scores associated with greater independence in daily activities.
Day 0,14,35, more than 35 days
Functional recovery of the upper limbs
Time Frame: Day 0,14,35, more than 35 days
Assesses impairment and activity limitation, as well as a restriction of leisure and work activities due to upper limb dysfunction. A higher score indicates a higher degree of disability.
Day 0,14,35, more than 35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lithuanian University of Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rytis Rimdeika, Prof, Lithuania LUHS hospital Kaunas Clinics, Department of Plastic and Reconstructive Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Brigita Siparyte-Sinkeviciene

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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