Gait Training in Patients With Burn Injury

NCT ID: NCT03217526

Last Updated: 2018-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Burns Gait Training Physical Functions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Gait Training

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Gait Training

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gait Training

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ozden Ozkal

MsC, PT

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ozden Ozkal

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34154896 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GO 16/786

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.