NCT06139731

Brief 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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

6 years

First QC Date

October 3, 2023

Last Update Submit

January 22, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Day 0,14,35, more than 35 days

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigita Siparytė-Sinkevičienė

Kaunas, Lithuania

RECRUITING

Study Officials

  • Rytis Rimdeika, Prof

    Lithuania LUHS hospital Kaunas Clinics, Department of Plastic and Reconstructive Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brigita Siparytė-Sinkevičienė

CONTACT

Rytis Rimdeika, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Brigita Siparyte-Sinkeviciene

Study Record Dates

First Submitted

October 3, 2023

First Posted

November 18, 2023

Study Start

January 1, 2020

Primary Completion

December 30, 2025

Study Completion

January 30, 2026

Last Updated

January 27, 2025

Record last verified: 2025-01

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