Evaluation of Gait Symmetry in Upper Extremity Burn Injuries

June 13, 2019 updated by: Ozden Ozkal, Hacettepe University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Ozden Ozkal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental Group
Thirty subjects with unilateral upper burn injury will be included in this study. GAITRite system for gait analysis, Tampa kinesiophobia scale for kinesiophobia level, visual analog scale for pain and a scale that developed by us for arm swing will be used. Their evaluations will be made within 5 days following burn injury.
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.

Other Names:
  • Arm Restriction
ACTIVE_COMPARATOR: Control Group
Thirty healthy subjects will be included in this study. GAITRite system for gait analysis, Tampa kinesiophobia scale for kinesiophobia level, visual analog scale for pain and a scale that developed by us for arm swing will be used. When their gait analysis made, they will be asked to walk their natural walking.
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.

Other Names:
  • Arm Restriction
SHAM_COMPARATOR: Control Grup (Restricted arm swing)
Thirty healthy subjects will be included in this study. GAITRite system for gait analysis, Tampa kinesiophobia scale for kinesiophobia level, visual analog scale for pain and a scale that developed by us for arm swing will be used. When their gait analysis made, their arms will be fixed with a bandage on their bodies. Their arm swing will be restricted.
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.

Other Names:
  • Arm Restriction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
through study completion, an average of 5 months
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.
through study completion, an average of 5 months
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.
through study completion, an average of 5 months
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.
through study completion, an average of 5 months
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.
through study completion, an average of 5 months
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.
through study completion, an average of 5 months
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.
through study completion, an average of 5 months
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.
through study completion, an average of 5 months
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.
through study completion, an average of 5 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 5 months
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.
through study completion, an average of 5 months
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.
through study completion, an average of 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Collaborators

Ankara Education and Research Hospital

Investigators

  • Principal Investigator: Ozden Ozkal, PhD, PT, Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ACTUAL)

May 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

November 25, 2018

First Submitted That Met QC Criteria

November 28, 2018

First Posted (ACTUAL)

November 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2019

Last Update Submitted That Met QC Criteria

June 13, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO 18/785

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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