Evaluation of Gait Symmetry in Upper Extremity Burn Injuries

NCT ID: NCT03759613

Last Updated: 2019-06-14

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-06-01

Brief Summary

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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

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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.

Conditions

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Burn Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Gait Analysis

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Gait Analysis

Intervention Type 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.

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.

Group Type SHAM_COMPARATOR

Gait Analysis

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Arm Restriction

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara Education and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Ozden Ozkal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ozden Ozkal, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Ozden Ozkal

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GO 18/785

Identifier Type: -

Identifier Source: org_study_id

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