NCT04157504

Brief Summary

This study evaluates scar tissue, normal range of motion of lowr extremity joints, lower extremity functions, functional capacity, functional mobility, kinesiophobia and quality of life in lower limb burn injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 10, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

2.3 years

First QC Date

November 6, 2019

Last Update Submit

August 25, 2020

Conditions

BurnsBurn ScarLower Limb InjuryLower Limb Wound

Keywords

Burn InjuryBalanceLower extremity functionburn scar

Outcome Measures

Primary Outcomes (2)

  • Lower Extremity Function

    The Lower extremity functional index is a questionnaire containing 25 items. The value of this questionnaire between 0 and 100. The higher value indicates worse physical function.

    10 minutes

  • Nottingham health profile

    Nottingham health profile is a questionnaire that evaluates quality of life. he lowest and highest scores that can be obtained from each sub-dimension of the scale are 0 and 100, respectively. 0 indicates the best health status while 100 indicates the worst health status.

    10 minutes

Secondary Outcomes (4)

  • scar tissue assessment

    10 minutes

  • Tampa kinesiophobia scale

    10 minutes

  • Six minutes walk test

    10 minutes

  • Timed up and go test

    5 minutes

Study Arms (1)

Experimental Group: Physical Function

EXPERIMENTAL

Forty patients with burn injury will be evaluated in this study. Lower extremity function, functional capacity, functional mobility, quality of life an scar tissue will be evaluated.

Other: Physical function assessment

Interventions

Physical function assessmentOTHER

Physical function assessment is a tool to evaluate mobility levels of patients

Experimental Group: Physical Function

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having a lower limb burns
  • To be a volunteer to participate

You may not qualify if:

  • orthopedic problems affecting gait and stance
  • Having a neurological disorders
  • Walking with assist device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozden Ozkal

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

BurnsLeg Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 8, 2019

Study Start

January 10, 2018

Primary Completion

April 15, 2020

Study Completion

May 1, 2020

Last Updated

August 26, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)