Cerebral Palsy, SpasticNCT04240275
Reliability of a Body-worn Sensor System for Gait Analysis in Children With CP
An observational study of Cerebral Palsy, Spastic and Gait Disorders, Neurologic, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (CP) is caused by a non-progressive injury in the developing brain, which leads to problems in functional mobility, posture, neuro musculoskeletal functions and gait. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Cerebral Palsy, Spastic, Gait Disorders, Neurologic
- What is being tested?
- Reliability of the G-Walk device in children with Cerebral Palsy
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2019to 30 Dec 2019
- Phase
- Observational
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with Spastic Cerebral Palsy who have involvement on one or two sides of the body, who can walk independently.
Who may be able to join
- Accepting to participate in the study,
- Being between 5-15 years old,
- Having a diagnosis of Spastic Cerebral Palsy,
- Being level I-II according to GMFCS
Who cannot join
- Having limited cooperation which prevents participation in the study,
- Refusing to participate in the study,
- Having an orthopedic disorder or systemic illness which prevents movement in the lower extremities,
- Having a Botulinum toxin application in the last 3 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of a Body-worn Sensor System for Analysis of Spatiotemporal Gait Parameters in Children With CP
Cerebral palsy (CP) is caused by a non-progressive injury in the developing brain, which leads to problems in functional mobility, posture, neuro musculoskeletal functions and gait. Around 75% of children with CP are ambulatory however they have gait problems such as excessive knee flexion, stiff knee, crouch gait or equinus which affects the quality of gait. When constructing an effective treatment plan in children with CP, a comprehensive assessment should be performed. One of the most essential assessments is gait analysis. Gait analysis is used in the quantitative assessment of gait disturbances providing functional diagnosis, assessment for treatment, planning, and monitoring of progress.
Gait analysis aims to determine the factors leading to gait disturbances. To reach this aim, a large amount of quantitative data concerning the gait characteristics of a patient is analyzed. The assessment of these data can be performed via standardized clinical videos, recorded with numerical video cameras used in conjunction with optical 3D systems. The purpose of this study was to confirm the test-retest reliability of a commercially available body-worn sensor- G-Walk® sensor system-for spatiotemporal gait parameters in children with CP.
Read the detailed description
The G-Walk determines spatiotemporal parameters as well as pelvic rotations during gait and allows objective and precise analysis of movements with its wearable inertial sensor. It also enables 3D kinematic analysis of the pelvis, providing a functional analysis of disorders in gait caused by neuromuscular diseases The device is placed on an elastic belt and worn on the waist of the person being evaluated, with the center of the device at the fifth lumbar vertebrae. To ensure correct placement of the device, the L4-L5 intervertebral space was palpated via the posterior superior iliac spines (SIPS).
After the accelerometer was placed, the children were asked to walk calmly at normal speed, on a 10 m track, whose boundaries were determined with colored lines and to return to the starting position.
The values and gait characteristics of acceleration in the anteroposterior (AP) and mediolateral (ML) axes were transferred to the computer software program.
The tilt of the pelvis in the sagittal plane in the flexion-extension direction, the oblique displacement in the coronal plane, the angles of the rotation of movement in the transverse plane and the symmetry values of the right and left sides are obtained. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrical
- Being tested
- Reliability of the G-Walk device in children with Cerebral Palsy
- Keywords
- Cerebral Palsy, Gait Assessment, G-Walk, Reliability
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reliability of the G-Walk device in children with Cerebral PalsyDevice
Also called Gait Analysis
The purpose of this study was to confirm the test-retest reliability of a commercially available body-worn sensor-G-Walk® sensor system-for spatiotemporal gait parameters in children with CP.
The children will be assessed with the G-Walk on two separate occasions.For the reliability analysis, the second measurement tests will be repeated 3 days after the first assessment.
The device is placed on an elastic belt and worn on the waist of the person being evaluated, with the center of the device at the fifth lumbar vertebrae. To ensure correct placement of the device, the L4-L5 intervertebral space will be palpated via the posterior superior iliac spines (SIPS).
After the accelerometer is placed, the children are asked to walk calmly at normal speed, on a 10 m track, whose boundaries will be determined with colored lines and to return to the starting position.
| Study group | Role | What they receive |
|---|---|---|
| Children with Cerebral Palsy | Children diagnosed with Spastic Cerebral Palsy (Unilateral or Bilateral) among the age range of 5-15 who can walk independently Receives: Device: Reliability of the G-Walk device in children with Cerebral Palsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Symmetry
Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed.
Gait symmetry values of the right and left sides are obtained within this report. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrical.
Measured: Reliability of the G-Walk in 3 days
Gait Speed
Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed.
For each subject, mean gait speed will be calculated from 10 consecutive steps in the gait cycles.
Measured: Reliability of the G-Walk in 3 days
Spatiotemporal gait parameters
Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed.
The device provides the data for the following spatiotemporal gait parameters in one single report; Cadence Stance Phase (%of gait) Swing Phase (%of gait) Stride Length (cm)
Measured: Reliability of the G-Walk in 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start3 Jun 2019
- Primary completion30 Sep 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Yazici, Gazi University
- Investigators
- Gokhan Yazici, Pt. PhD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240275
- Sponsor's protocol ID
- 12355
- Status last verified
- Jan 2020
- First submitted
- 20 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be available to other researchers.
Publications
De Ridder R, Lebleu J, Willems T, De Blaiser C, Detrembleur C, Roosen P. Concurrent Validity of a Commercial Wireless Trunk Triaxial Accelerometer System for Gait Analysis. J Sport Rehabil. 2019 Aug 1;28(6):jsr.2018-0295. doi: 10.1123/jsr.2018-0295.
PubMed 30747572Kleiner AFR, Pacifici I, Vagnini A, Camerota F, Celletti C, Stocchi F, De Pandis MF, Galli M. Timed Up and Go evaluation with wearable devices: Validation in Parkinson's disease. J Bodyw Mov Ther. 2018 Apr;22(2):390-395. doi: 10.1016/j.jbmt.2017.07.006. Epub 2017 Jul 25.
PubMed 29861240Armand S, Decoulon G, Bonnefoy-Mazure A. Gait analysis in children with cerebral palsy. EFORT Open Rev. 2016 Dec 22;1(12):448-460. doi: 10.1302/2058-5241.1.000052. eCollection 2016 Dec.
PubMed 28698802
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of a Body-worn Sensor System for Analysis of Spatiotemporal Gait Parameters in Children With CP
- ClinicalTrials.gov ID
- NCT04240275
- Acronym / sponsor ID
- 12355
- Keywords
- Cerebral Palsy, Gait Assessment, G-Walk, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 27 Jan 2020 (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.
Cerebral palsy (CP) is caused by a non-progressive injury in the developing brain, which leads to problems in functional mobility, posture, neuro musculoskeletal functions and gait. Around 75% of children with CP are ambulatory however they have gait problems such as excessive knee flexion, stiff knee, crouch gait or equinus which affects the quality of gait. When constructing an effective treatment plan in children with CP, a comprehensive assessment should be performed. One of the most essential assessments is gait analysis. Gait analysis is used in the quantitative assessment of gait disturbances providing functional diagnosis, assessment for treatment, planning, and monitoring of progress.
Gait analysis aims to determine the factors leading to gait disturbances. To reach this aim, a large amount of quantitative data concerning the gait characteristics of a patient is analyzed. The assessment of these data can be performed via standardized clinical videos, recorded with numerical video cameras used in conjunction with optical 3D systems. The purpose of this study was to confirm the test-retest reliability of a commercially available body-worn sensor- G-Walk® sensor system-for spatiotemporal gait parameters in children with CP.
Detailed description
The G-Walk determines spatiotemporal parameters as well as pelvic rotations during gait and allows objective and precise analysis of movements with its wearable inertial sensor. It also enables 3D kinematic analysis of the pelvis, providing a functional analysis of disorders in gait caused by neuromuscular diseases The device is placed on an elastic belt and worn on the waist of the person being evaluated, with the center of the device at the fifth lumbar vertebrae. To ensure correct placement of the device, the L4-L5 intervertebral space was palpated via the posterior superior iliac spines (SIPS).
After the accelerometer was placed, the children were asked to walk calmly at normal speed, on a 10 m track, whose boundaries were determined with colored lines and to return to the starting position.
The values and gait characteristics of acceleration in the anteroposterior (AP) and mediolateral (ML) axes were transferred to the computer software program.
The tilt of the pelvis in the sagittal plane in the flexion-extension direction, the oblique displacement in the coronal plane, the angles of the rotation of movement in the transverse plane and the symmetry values of the right and left sides are obtained. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrical
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Cerebral Palsy | – | Device: Reliability of the G-Walk device in children with Cerebral PalsyChildren diagnosed with Spastic Cerebral Palsy (Unilateral or Bilateral) among the age range of 5-15 who can walk independently |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with Spastic Cerebral Palsy who have involvement on one or two sides of the body, who can walk independently.
Key inclusion criteria (4 listed)
- Accepting to participate in the study,
- Being between 5-15 years old,
- Having a diagnosis of Spastic Cerebral Palsy,
- Being level I-II according to GMFCS
Key exclusion criteria (4 listed)
- Having limited cooperation which prevents participation in the study,
- Refusing to participate in the study,
- Having an orthopedic disorder or systemic illness which prevents movement in the lower extremities,
- Having a Botulinum toxin application in the last 3 month
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 |
|---|---|---|
| Reliability of the G-Walk device in children with Cerebral PalsyAlso: Gait AnalysisThe purpose of this study was to confirm the test-retest reliability of a commercially available body-worn sensor-G-Walk® sensor system-for spatiotemporal gait parameters in children with CP. The children will be assessed with the G-Walk on two separate occasions.For the reliability analysis, the second measurement tests will be repeated 3 days after the first assessment. The device is placed on an elastic belt and worn on the waist of the person being evaluated, with the center of the device at the fifth lumbar vertebrae. To ensure correct placement of the device, the L4-L5 intervertebral space will be palpated via the posterior superior iliac spines (SIPS). After the accelerometer is placed, the children are asked to walk calmly at normal speed, on a 10 m track, whose boundaries will be determined with colored lines and to return to the starting position. | Device | Children with Cerebral Palsy |
Primary outcome
Gait Symmetry
Time frame: Reliability of the G-Walk in 3 days
Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed. Gait symmetry values of the right and left sides are obtained within this report. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrical.
Gait Speed
Time frame: Reliability of the G-Walk in 3 days
Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed. For each subject, mean gait speed will be calculated from 10 consecutive steps in the gait cycles.
Spatiotemporal gait parameters
Time frame: Reliability of the G-Walk in 3 days
Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed. The device provides the data for the following spatiotemporal gait parameters in one single report; Cadence Stance Phase (%of gait) Swing Phase (%of gait) Stride Length (cm)
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 27 Jan 2020.
- Background: PubMed 30747572De Ridder R, Lebleu J, Willems T, De Blaiser C, Detrembleur C, Roosen P. Concurrent Validity of a Commercial Wireless Trunk Triaxial Accelerometer System for Gait Analysis. J Sport Rehabil. 2019 Aug 1;28(6):jsr.2018-0295. doi: 10.1123/jsr.2018-0295.
- Background: PubMed 29861240Kleiner AFR, Pacifici I, Vagnini A, Camerota F, Celletti C, Stocchi F, De Pandis MF, Galli M. Timed Up and Go evaluation with wearable devices: Validation in Parkinson's disease. J Bodyw Mov Ther. 2018 Apr;22(2):390-395. doi: 10.1016/j.jbmt.2017.07.006. Epub 2017 Jul 25.
- Background: PubMed 28698802Armand S, Decoulon G, Bonnefoy-Mazure A. Gait analysis in children with cerebral palsy. EFORT Open Rev. 2016 Dec 22;1(12):448-460. doi: 10.1302/2058-5241.1.000052. eCollection 2016 Dec.
- Individual participant dataSharing planned: No. The data will not be available to other researchers.
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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.
Gokhan Yazici, Pt. PhD principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, Spastic and Gait Disorders, Neurologic, run by Gazi 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 4 inclusion and 4 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 27 Jan 2020. 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. 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 Symmetry (time frame: Reliability of the G-Walk in 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04240275, which also lists 3 linked publications.
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 27 Jan 2020.