Burn of Upper Limb, Except Wrist and HandNCT06139731
Changes in Function of the Upper Limb With Physiotherapy
An observational study of Burn of Upper Limb, Except Wrist and Hand, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burn of Upper Limb, Except Wrist and Hand
- How many people
- 17 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Jan 2020to 30 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rytis Rimdeika, Prof contact
Lithuania1 site, 1 recruiting
- Recruiting
Brigita Siparytė-Sinkevičienė
Kaunas
Brigita Siparytė-Sinkevičienė, +37068294149, brigita.siparyte@lsmu.lt
About this study
Official title: 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.
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb range of motion
A range of motion assessment evaluates the mobility of the injured joint and assesses the limitations of the range of motion.
Measured: Day 0, 7,14,21, 28, 35, more 35 days
Upper limb muscle strength
Assessing muscle strength helps determine how much muscle strength will be lost as a patient heals from a burn injury.
Measured: Day 0,14,35, more than 35 days
Pain intensity
The pain rate scale assesses the intensity of pain. A higher score indicates a higher level of pain.
Measured: Day 0, 7,14,21, 28, 35, more than 35 days
Activities of daily living
Assessment of daily activity assesses the limitations of your daily activities. Higher scores associated with greater independence in daily activities.
Measured: Day 0,14,35, more than 35 days
Functional recovery of the upper limbs
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.
Measured: Day 0,14,35, more than 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jan 2020
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn of Upper Limb, Except Wrist and HandStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brigita Siparyte-Sinkeviciene, Lithuanian University of Health Sciences
- Investigators
- Rytis Rimdeika, Prof, Principal investigator, Lithuania LUHS hospital Kaunas Clinics, Department of Plastic and Reconstructive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139731
- Sponsor's protocol ID
- Brigita Siparyte-Sinkeviciene
- Status last verified
- Jan 2025
- First submitted
- 3 Oct 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Function of the Upper Limb With Physiotherapy for Acute Burns: a Pilot Study
- ClinicalTrials.gov ID
- NCT06139731
- Acronym / sponsor ID
- Brigita Siparyte-Sinkeviciene
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 18 Nov 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: Undecided
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.
Rytis Rimdeika, Prof contact
Rytis Rimdeika, Prof principal investigator
Lithuania LUHS hospital Kaunas Clinics, Department of Plastic and Reconstructive Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn of Upper Limb, Except Wrist and Hand, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brigita Siparytė-Sinkevičienė (+37068294149, brigita.siparyte@lsmu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper limb range of motion (time frame: Day 0, 7,14,21, 28, 35, more 35 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2025.