Gait Training in Patients With Burn Injury

November 25, 2018 updated by: Ozden Ozkal, Hacettepe University

Investigation of the Effect of Different Gait Training on Physical Functions in Patients With Lower Extremity Burn Injury

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Twenty-four individuals with lower extremity burn injury will be included in this study. Participants will be included if they are aged of 18-50, able to walk independently at least 10 meters.

Participants will be divided in two groups; Intervention and control groups. Intervention group: standart rehabilitation program and gait training on the overground will be applied.

Conntrol Group:standart rehabilitation program and gait training on the treadmill will be applied.

Rehabilitation program will applied by physiotherapist during the acute hospitalization. Standart rehabilitation will include active range of motion exercises, functional mobility, balance activities.

Participants 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. GAITRite system for 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), timed up and go test (TUG) for dynamic balance and six minute walk test (6MWT) for exercise capacity, will be used. These evaluations will be made twice; initial (admission) and final (discharge).

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06100
        • Ozden Ozkal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ex Group

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.

Gait Training: Training will be applied by a physiotherapist on a treadmill or on an overgorund.
Experimental: Ex +WT Group
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.
Gait Training: Training will be applied by a physiotherapist on a treadmill or on an overgorund.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cadence
Time Frame: It will be measured while walking on a GITRite system. It is about 5 meters electronically sensored carpet. Inıtially evaluation at first minute
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
Time Frame: Inıtially evaluation at first minute. It will be measured while walking on a GITRite system. It is about 5 meters electronically sensored carpet.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
six minute walk test
Time Frame: the distance at the en of Six minute
this test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes The distance at the end of six minute will be recordedn.
the distance at the en of Six minute
Timed up and go test
Time Frame: Inıtially evaluation in first minute
The patient sits in the chair with his/her back against the chair back On the command "go", the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down Timing begins at the instruction "go" and stops when the patient is seated. The time will be recorded.
Inıtially evaluation in first minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

July 12, 2017

First Submitted That Met QC Criteria

July 12, 2017

First Posted (Actual)

July 14, 2017

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 25, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO 16/786

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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