Evaluation of Gait Symmetry in Upper Extremity Burn Injuries

Burn Injury Clinical Trial

Official title:

Evaluation of Gait Symmetry in Patients With Unilateral Upper Extremity Burn Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03759613
• Other study ID #: GO 18/785
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: November 2018
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Injury
• Burns
• Wounds and Injuries

Intervention

Other:
• Gait Analysis
Gait Analysis: Gait analysis is not a routine assessment tool for upper extremity burn injuries. This analysis is an assessment method to estimate gait symmetry. Restriction arm swing: Participants in group will be restricted for arm swing using a bandage. Thus, the reciprocal arm swing will be prevented.

Locations

Country	Name	City	State
Turkey	Ozden Ozkal	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	Ankara Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Speed	It is measured by computerized gait analysis system. Speed is the distance walked per unit of time. It is determined in centimeters per second (cm/sec)	through study completion, an average of 5 months
Primary	step length	It is measured by computerized gait analysis system. Difference in position between the feet at heel strike, in the direction of forward motion. The unit of measure is centimeters. It is calculated both right and left foot.	through study completion, an average of 5 months
Primary	Swing phase	It is measured by computerized gait analysis system. Swing Phase,which accounts for 40% of a single gait cycle, the phase during which the foot is not in contact with the ground. It is expressed in seconds (sec) and as a percentage of the gait cycle of the same foot. It is calculated both right and left foot.	through study completion, an average of 5 months
Primary	Stance Phase	It is measured by computerized gait analysis system.The gait phase that lasts from heel strike to toe off, which accounts for 60% of a single gait cycle. It is expressed in seconds (sec) and as a percentage of the gait cycle of the same foot. It is calculated both right and left foot.	through study completion, an average of 5 months
Primary	Single Support	It is measured by computerized gait analysis system. Only one foot in contact with the floor. It is expressed as a percentage of the gait cycle. It is calculated both right and left foot.	through study completion, an average of 5 months
Primary	Double Support	It is measured by computerized gait analysis system. Boot feet in contact with the floor. It is expressed as a percentage of the gait cycle. It is calculated both right and left foot.	through study completion, an average of 5 months
Primary	Gait symmetry index	It's calculated in order to evaluate symmetry for bilateral parameters of gait. The value of symmetry index =0 equals full symmetry. Minimum score is 0 indicates perfect symmetry. Maximum score is endless. The higher score is indicated the more asymmetrica gait pattern.	through study completion, an average of 5 months
Primary	Cadence	It is measured by computerized gait analysis system. Rhythm expressed in steps per second.	through study completion, an average of 5 months
Primary	Base support	It is measured by computerized gait analysis system. It is the distance between two linescutting feet equal halves. The unit of measure is centimeters.	through study completion, an average of 5 months.
Secondary	Tampa Kinesiophobia Scale	This scale consists of a 17-item self-report questionnaire that measures the fear of re-injury because of movement. Items are scored on a 4-point Likert scale ranging from 1 "strongly disagree" to 4 "strongly agree". The total scores for scale range from 17 to 68. Maximum score means higher level of kinesiophobia.	through study completion, an average of 5 months
Secondary	Pain severity	Pain severity was assessed by visual analogue scale. This scale score range from "no pain=0 point " to "worst imaginable pain=10 points" for intensity. Maximum point means worst pain severity.	through study completion, an average of 5 months
Secondary	Arm swing	Arm swing will be evaluated with an arm swing scale. Arm swing scale consists of a 5 item questions for each side (left arm-right arm). Totally, scale consist of 10 questions. Scale score range from "10 points: indicates normal arm swing" to "0 points: indicates totally restricted arm swing. Maximum score means best arm swing.	through study completion, an average of 5 months