- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03217526
Gait Training in Patients With Burn Injury
Investigation of the Effect of Different Gait Training on Physical Functions in Patients With Lower Extremity Burn Injury
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06100
- Ozden Ozkal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Burns
-
Fondation Ophtalmologique Adolphe de RothschildNot yet recruiting
-
MediWound LtdUnknownBurns, Upper Extremity | Burns, Lower ExtremitySlovakia
-
Singapore General HospitalUnknownAcute Thermal BurnsSingapore
-
RenovaCare, IncActive, not recruitingBurns | Burns Second Degree | Burns Deep Second DegreeUnited States
-
American Scitech InternationalJohnson & JohnsonUnknownBurns | Electric BurnsUnited States
-
Sun Yat-sen UniversityCompleted
-
Hennepin Healthcare Research InstituteNot yet recruiting
-
Buckinghamshire Healthcare NHS TrustNot yet recruitingBurns Multiple
-
Virginia Commonwealth UniversityNot yet recruiting
-
Riphah International UniversityActive, not recruiting
Clinical Trials on Gait Training
-
Gaziler Physical Medicine and Rehabilitation Education...RecruitingStroke | Balance | Gait Training | Walking ImpairmentTurkey (Türkiye)
-
Alvernia UniversityGood Shepherd Rehabilitation NetworkTerminatedStroke | Gait, HemiplegicUnited States
-
Biruni UniversityRecruitingChronic StrokeTurkey (Türkiye)
-
Hangang Sacred Heart HospitalRecruitingBurns | Rehabilitation | Gait TrainingKorea, Republic of
-
Cairo UniversityCompleted
-
University of Sao PauloFederal University of São Paulo; Universidade do Oeste PaulistaRecruiting
-
Mahidol UniversityCompletedMild Cognitive ImpairmentThailand
-
Hangang Sacred Heart HospitalMinistry of Health, Republic of KoreaCompletedBurns | Gait Disorder, SensorimotorKorea, Republic of
-
National Rehabilitation Center, Seoul, KoreaCompletedStrokeKorea, Republic of
-
National Taiwan University HospitalRecruitingParkinson Disease | Gait Disorders, NeurologicTaiwan