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Gait Training in Patients With Burn Injury

Primary Purpose

Burns, Gait Training, Physical Functions

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Gait Training
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Burns focused on measuring Burn injury, Gait, Physical Function

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ozden Ozkal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ex Group

Ex +WT Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cadence
Walking speed
step length
Step Lenght assessment while walking

Secondary Outcome Measures

six minute walk test
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.
Timed up and go test
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.

Full Information

First Posted
July 12, 2017
Last Updated
November 25, 2018
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03217526
Brief Title
Gait Training in Patients With Burn Injury
Official Title
Investigation of the Effect of Different Gait Training on Physical Functions in Patients With Lower Extremity Burn Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Gait Training, Physical Functions
Keywords
Burn injury, Gait, Physical Function

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ex Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ex +WT Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Gait Training
Intervention Description
Gait Training: Training will be applied by a physiotherapist on a treadmill or on an overgorund.
Primary Outcome Measure Information:
Title
Cadence
Description
Walking speed
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
Title
step length
Description
Step Lenght assessment while walking
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.
Secondary Outcome Measure Information:
Title
six minute walk test
Description
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.
Time Frame
the distance at the en of Six minute
Title
Timed up and go test
Description
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.
Time Frame
Inıtially evaluation in first minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ozden Ozkal
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
34154896
Citation
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.
Results Reference
derived

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Gait Training in Patients With Burn Injury

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