CClinicalTrials.gg
CompletedNCT04157504Updated Aug 26, 2020

Evaluation of Physical Functions in Lower Limb Burn Injury

An interventional study of Physical function assessment in Burns, Burn Scar and Lower Limb Injury, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-26.

Sponsored by Hacettepe University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jan 2018, registered Nov 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

Patients with lower extremity burns experience problems with range of motion, muscle strength, balance and gait. These problems contribute to prolonged physical disability, return to work or deterioration of work capacity and thus lead to a negative impact on quality of life.

In addition to studies showing that quality of life and functions may be affected adversely after burn, there are studies showing that burn percentage, health-related quality of life and functional outcomes are affected. The aim of this study is to determine the effects of burn area (with or without joint), percentage of burns and hypertrophic scar on the patient's function in patients with lower extremity burns.

02

Conditions studied

  • Burns
  • Burn Scar
  • Lower Limb Injury
  • Lower Limb Wound

Keywords

  • Burn Injury
  • Balance
  • Lower extremity function
  • burn scar
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 42 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • orthopedic problems affecting gait and stance
  • Having a neurological disorders
  • Walking with assist device
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Experimental Group: Physical Function

    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

  • OtherPhysical function assessment

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 minutes

  2. 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.

    Time frame: 10 minutes

Secondary outcomes

  1. scar tissue assessment

    The Patient and Observer Scar Assessment Scale consists of the total score of two numeric scales measured by the patient and a qualified observer. Each scale assesses the scar by six characteristics on 10-point scales with a 1 corresponding to normal skin and a 10 representing the worst imaginable condition for that characteristic. The Total Score of both scales is calculated by summing scores of the six items resulting in a range of 6 to 60.

    Time frame: 10 minutes

  2. Tampa kinesiophobia scale

    This scale consists of a 17-item self-report questionnaire that measures the fear of re-injury because of movement. Items are scored on a 4-point Likert scale ranging from 1 "strongly disagree" to 4 "strongly agree". The total scores for scale range from 17 to 68. Maximum score means higher level of kinesiophobia.

    Time frame: 10 minutes

  3. Six minutes walk test

    It was evaluated by six minutes walk test.The 6-min walk test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The distance will be recorded. The higher distance is indicated better exercise capacity.

    Time frame: 10 minutes

  4. Timed up and go test

    Timed up and go test evaluates dynamic balance of participants. The timed up and go test measures the time that a patient needs to stand up from a chair, walk a 3-m distance, come back and sit back on the chair.Timed up and go test measure is second. The lower values indicates the better balance

    Time frame: 5 minutes

07

Study locations

1 site
  • Ozden Ozkal
    Ankara, 06100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04157504
Lead sponsor
Hacettepe University
Responsible party
Ozden Ozkal (Principal Investigator, Hacettepe University) — Principal investigator
First posted
Nov 8, 2019
Start date
Jan 10, 2018
Primary completion
Apr 15, 2020
Completion
May 1, 2020
Last update
Aug 26, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion