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Completed

NCT Number: NCT03759613

Evaluation of Gait Symmetry in Upper Extremity Burn Injuries

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.

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Key information

Conditions

Burn Injury Burns Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ozden Ozkal

Ankara, 06100, Turkey (Türkiye)

About this study

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.

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gait Analysis

Other

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.

Other names: Arm Restriction

Primary outcomes

  1. Gait Speed

    Time frame: through study completion, an average of 5 months

    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)

  2. step length

    Time frame: through study completion, an average of 5 months

    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.

  3. Swing phase

    Time frame: through study completion, an average of 5 months

    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.

  4. Stance Phase

    Time frame: through study completion, an average of 5 months

    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.

  5. Single Support

    Time frame: through study completion, an average of 5 months

    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.

  6. Double Support

    Time frame: through study completion, an average of 5 months

    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.

  7. Gait symmetry index

    Time frame: through study completion, an average of 5 months

    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.

  8. Cadence

    Time frame: through study completion, an average of 5 months

    It is measured by computerized gait analysis system. Rhythm expressed in steps per second.

  9. Base support

    Time frame: through study completion, an average of 5 months.

    It is measured by computerized gait analysis system. It is the distance between two linescutting feet equal halves. The unit of measure is centimeters.

Secondary outcomes

  1. Tampa Kinesiophobia Scale

    Time frame: through study completion, an average of 5 months

    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.

  2. Pain severity

    Time frame: through study completion, an average of 5 months

    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.

  3. Arm swing

    Time frame: through study completion, an average of 5 months

    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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • Ankara Education and Research Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 30, 2018
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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