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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03217526
Other study ID # GO 16/786
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date August 1, 2018

Study information

Verified date February 2018
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date August 1, 2018
Est. primary completion date August 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Ozden Ozkal Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cadence Walking speed It will be measured while walking on a GITRite system. It is about 5 meters electronically sensored carpet. Initially evaluation at first minute
Primary step length Step Lenght assessment while walking Initially evaluation at first minute. It will be measured while walking on a GITRite system. It is about 5 meters electronically sensored carpet.
Secondary 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. the distance at the en of Six minute
Secondary 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. Initially evaluation in first minute
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