- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06139731
Changes in Function of the Upper Limb With Physiotherapy
November 15, 2023 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
Recruiting
Conditions
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
Observational
Enrollment (Estimated)
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
- Name: Brigita Siparytė-Sinkevičienė
- Phone Number: +37068294149
- Email: brigita.siparyte@lsmu.lt
Study Contact Backup
- Name: Rytis Rimdeika, Prof
- Email: Rytis.Rimdeika@kaunoklinikos.lt
Study Locations
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Kaunas, Lithuania
- Recruiting
- Brigita Siparytė-Sinkevičienė
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Contact:
- Brigita Siparytė-Sinkevičienė
- Phone Number: +37068294149
- Email: brigita.siparyte@lsmu.lt
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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
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
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.
Investigators
- 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)
January 1, 2020
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
November 30, 2024
Study Registration Dates
First Submitted
October 3, 2023
First Submitted That Met QC Criteria
November 15, 2023
First Posted (Actual)
November 18, 2023
Study Record Updates
Last Update Posted (Actual)
November 18, 2023
Last Update Submitted That Met QC Criteria
November 15, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID 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.
Clinical Trials on Burn of Upper Limb, Except Wrist and Hand
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Shirley Ryan AbilityLabEunice Kennedy Shriver National Institute of Child Health and Human Development...Active, not recruitingAmputation | Amputation; Traumatic, Limb | Upper Limb Amputation at the Hand | Upper Limb Amputation at the WristUnited States
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Liberating Technologies, Inc.WithdrawnAmputation | Prosthesis User | Amputation; Traumatic, Hand | Amputation, Traumatic | Upper Limb Amputation at the Hand | Upper Limb Amputation Below Elbow (Injury) | Limb; Absence, Congenital, Upper
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Shirley Ryan AbilityLabCoapt, LLCRecruitingLower Limb Amputation Below Knee (Injury) | Lower Limb Amputation Above Knee (Injury) | Amputation | Phantom Limb Pain | Phantom Pain | Phantom Sensation | Lower Limb Amputation Knee | Lower Limb Amputation at Ankle (Injury) | Upper Limb Amputation at the Hand | Upper Limb Amputation at the Wrist | Upper... and other conditionsUnited States
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Liberating Technologies, Inc.Össur EhfCompletedAmputation | Prosthesis User | Amputation; Traumatic, Hand | Upper Limb Amputation at the Hand | Limb; Absence, Congenital, UpperUnited States
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SportWelding GmbHUnknownLesion of Ligament of Wrist and/or HandAustria
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TC Erciyes UniversityUnknownInjury of Radial Artery at Wrist and Hand Level | Injury; Ulnar Artery, Hand and WristTurkey
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Hospices Civils de LyonUnknownBilateral Upper Limb Amputation | Transverse Short Amputation of the Hand | Arm AmputationFrance
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Integra LifeSciences CorporationVanderbilt University Medical CenterWithdrawnPartial Thickness Burn of Hand