Burn InjuryNCT03759613
Evaluation of Gait Symmetry in Upper Extremity Burn Injuries
A study testing Gait Analysis in people with Burn Injury, run by Hacettepe University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn Injury
- What is being tested?
- Gait Analysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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.
- Conditions
- Burn Injury
- Being tested
- Gait Analysis
- Keywords
- Burn Injury, Gait Symmetry, Arm Swing
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait AnalysisOther
Also called Arm Restriction
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Gait Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 5 months
Cadence
It is measured by computerized gait analysis system. Rhythm expressed in steps per second.
Measured: 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.
Measured: through study completion, an average of 5 months.
Secondary outcomes (3)
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.
Measured: through study completion, an average of 5 months
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.
Measured: through study completion, an average of 5 months
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.
Measured: through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Dec 2018
- Primary completion1 May 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Education and Research Hospital
- Responsible party
- Principal investigator, Ozden Ozkal, Hacettepe University
- Investigators
- Ozden Ozkal, PhD, PT, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759613
- Sponsor's protocol ID
- GO 18/785
- Status last verified
- Nov 2018
- First submitted
- 25 Nov 2018
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gait Symmetry in Patients With Unilateral Upper Extremity Burn Injury
- ClinicalTrials.gov ID
- NCT03759613
- Acronym / sponsor ID
- GO 18/785
- Conditions
- Burn Injury
- Keywords
- Burn Injury, Gait Symmetry, Arm Swing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Ankara Education and Research Hospital
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Gait AnalysisThirty 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. |
| Control Group | Active comparator | Other: Gait AnalysisThirty 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. |
| Control Grup (Restricted arm swing) | Sham comparator | Other: Gait AnalysisThirty 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait AnalysisAlso: Arm RestrictionGait 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 | Control Group, Control Grup (Restricted arm swing), Experimental Group |
Primary outcome
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)
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.
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Tampa Kinesiophobia Scale
Time frame: through study completion, an average of 5 months
Pain severity
Time frame: through study completion, an average of 5 months
Arm swing
Time frame: through study completion, an average of 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozden Ozkal, PhD, PT principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait Analysis in people with Burn Injury, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Speed (time frame: through study completion, an average of 5 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.