Evaluation of Gait Symmetry in Upper Extremity Burn Injuries

NCT03759613 | Completed

• 1 other identifier: GO 18/785
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Injury

Keywords

Burn Injury; Gait Symmetry; Arm Swing

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Cadence

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

  through study completion, an average of 5 months

• 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 Outcomes (3)

• Tampa Kinesiophobia Scale

  through study completion, an average of 5 months

• Pain severity

  through study completion, an average of 5 months

• Arm swing

  through study completion, an average of 5 months

Study Arms (3)

Experimental Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Control Grup (Restricted arm swing)

SHAM COMPARATOR

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

Interventions

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.

Also known as: Arm Restriction

Control Group; Control Grup (Restricted arm swing); Experimental Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead
• Ankara Education and Research Hospital: collaborator

Study Sites (1)

Ozden Ozkal

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Burns

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Officials

• Ozden Ozkal, PhD, PT

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: November 30, 2018
• Study Start: December 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 14, 2019

Record last verified: 2018-11

Locations

TU (1)