Clinical trial NCT03759613: Evaluation of Gait Symmetry in Upper Extremity Burn Injuries
Official title: Evaluation of Gait Symmetry in Patients With Unilateral Upper Extremity Burn Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Injury
Keywords: Burn Injury
Gait Symmetry
Arm Swing
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Ankara Education and Research Hospital
First posted: 2018-11-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Thirty patients with unilateral burn injury, and 60 healthy subjects will be included in this study. Participants with burn injury will evaluate with the following assessment tools: Demographic data; age, gender, height, body mass index; burn characteristics; 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 computerized system. And gait symmetry will be calculated via formule. Participants' kinesiophobia level will be evaluated with Tampa kinesiophobia scale. Their pain will be assessed by visual analog scale. Their arm swing will be evaluated by a scale.

Detailed description: Thirty individuals with lower extremity burn injury and sixty healthy subjects will be included in this study. Participants with burn injury will be included if they are aged of 18-50, able to walk independently at least 10 meters. Healthy subjects will be included if there are no orthopedic, neurological or musculoskeletal disorders that affect gait.

1. Group: 30 Patients with burn injury
2. Group: 30 healthy subjects (When evaluating the gait analysis, their arm will not be restricted (Their natural walking)
3. Group : 30 healthy subject (When evaluating the gait analysis, their arm will be restricted )

Participants will evaluate with the following assessment tools: Demographic data; age, gender, height, body mass index; burn characteristics; type of burn injury, degree of burn injury, localization of burn injury and total burn surface area will be recorded.

All subjects' gait analysis will be conducted via GAITRite (computerized) system.

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), Tampa Kinesiophobia scale for kinesiophobia level, visual analog scale for pain, a scale that developed by us for arm swing will be used.

These evaluations will be applied one time for participants. These evaluations will be made within 5 days following burn injury.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of upper extremity burn injury
* must be able to walk independently
* Control group consists of healthy adults with the similar demographic characteristics as experimental group.

Exclusion Criteria:

* Walking with assist device
* Having a visual deficits
* Having an orthopedic problems that affect gait
* Having a neurological disorders
* Having a musculoskeletal disorders that affect gait
* Having an undergone orthopedic surgery

Primary outcomes:
measure: Gait Speed
timeFrame: through study completion, an average of 5 months
measure: step length
timeFrame: through study completion, an average of 5 months
measure: Swing phase
timeFrame: through study completion, an average of 5 months
measure: Stance Phase
timeFrame: through study completion, an average of 5 months
measure: Single Support
timeFrame: through study completion, an average of 5 months
measure: Double Support
timeFrame: through study completion, an average of 5 months
measure: Gait symmetry index
timeFrame: through study completion, an average of 5 months
measure: Cadence
timeFrame: through study completion, an average of 5 months
measure: Base support
timeFrame: through study completion, an average of 5 months.
Secondary outcomes:
measure: Tampa Kinesiophobia Scale
timeFrame: through study completion, an average of 5 months
measure: Pain severity
timeFrame: through study completion, an average of 5 months
measure: Arm swing
timeFrame: through study completion, an average of 5 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ozden Ozkal
Study officials:
affiliation: Hacettepe University
name: Ozden Ozkal, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: