NCT03217526

Brief Summary

Twenty-four individuals with burn injury will be included in this study. Participants with burn injury will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass index; burn caharacteristics; type of burn injury, degree of burn injury, localization of burn injury and total burn surface area will be recorded. Gait parameters (step length, stride length, base support, step time, cycle time, cadence, velocity, single support, double support, swing ( % of gait cycle) and stance (% of gait cycle). will be recorded via GAITRite system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

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

First Submitted

Initial submission to the registry

July 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 27, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

July 12, 2017

Last Update Submit

November 25, 2018

Conditions

Keywords

Burn injuryGaitPhysical Function

Outcome Measures

Primary Outcomes (2)

  • Cadence

    Walking speed

    It will be measured while walking on a GITRite system. It is about 5 meters electronically sensored carpet. Inıtially evaluation at first minute

  • step length

    Step Lenght assessment while walking

    Inıtially evaluation at first minute. It will be measured while walking on a GITRite system. It is about 5 meters electronically sensored carpet.

Secondary Outcomes (2)

  • six minute walk test

    the distance at the en of Six minute

  • Timed up and go test

    Inıtially evaluation in first minute

Study Arms (2)

Ex Group

ACTIVE COMPARATOR

EX: Standard exercise program (EX) (active range-of otion exercises, balance and mobility exercises) and walking training on the overground. This rehabilitation program physiotherapist will be applied to participants for five days a week. Walking training will be applied according to the gait speed determined by GAITRite computerized gait analysis system at initial assessment. Individuals will be instructed to walk with verbal commands and encourage them to continue their walk at constant speed.The duration of walking training will be recorded every day. The walking time will be determined according to the fatigue level of the individual. The level of fatigue of the individual will be questioned according to the modified borg scale.

Other: Gait Training

Ex +WT Group

EXPERIMENTAL

Ex: A standard exercise (SE) (active range-of otion exercises, balance and mobility exercises) WT: walking training on the treadmill (WT). This rehabilitation program physiotherapist will be applied to participants for five days a week.Walking training will be applied according to the gait speed determined by GAITRite computerized gait analysis system at initial assessment. Individuals will be trained on the treadmill.The duration of walking training and the speed of walking training will be recorded every day. The walking time will be determined according to the fatigue level of the individual. The level of fatigue of the individual will be questioned according to the modified borg scale.

Other: Gait Training

Interventions

Gait Training: Training will be applied by a physiotherapist on a treadmill or on an overgorund.

Ex +WT GroupEx Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • participiants who have lower extremity burn injury and able to walk independently 10 meters

You may not qualify if:

  • f there is a medical condition that prevents the ambulance of the individual and oxygen is needed for ambulance, participants will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozden Ozkal

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • Ozkal O, Kismet K, Konan A, Hayran M, Topuz S. Treadmill versus overground gait training in patients with lower limb burn injury: A matched control study. Burns. 2022 Feb;48(1):51-58. doi: 10.1016/j.burns.2021.04.019. Epub 2021 Apr 24.

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MsC, PT

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 14, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

November 27, 2018

Record last verified: 2018-02

Locations