Cerebral PalsyNCT03662139
Dynamic Gait Index in Hemiplegic Cerebral Palsy
An observational study of Cerebral Palsy and Hemiplegic Cerebral Palsy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to assess validity and reliability of Dynamic Gait Index (DGI) in patients with unilateral spastic cerebral palsy Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Hemiplegic Cerebral Palsy, Gait Disorders, Neurologic
- What is being tested?
- Dynamic Gait Index
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 1 Dec 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 16 spastic unilateral cerebral palsy patients, between 6 - 14 years of age, and 16 healthy volunteer peers
Who may be able to join
- Confirmed diagnosis of spastic unilateral cerebral palsy
- Age between 4 - 16
- Able to stand and walk without any orthosis or special equipment
- Volunteer to study
Who cannot join
- Being unable to walk
- Having cognitive disorder
- History of orthopedic surgery or any intervention for spasticity within the previous 12 months
- Uncontrolled epilepsy
- Visual conditions that prevent full participation to assessments
- Lower extremity contracture that may affect assessments
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, 34899
About this study
Official title: Reliability and Validity of the Dynamic Gait Index in Children With Hemiplegic Cerebral Palsy
The purpose of this study is to assess validity and reliability of Dynamic Gait Index (DGI) in patients with unilateral spastic cerebral palsy
Read the detailed description
Cerebral Palsy (CP) is a childhood onset, lifelong neurological disorder, attributed to non-progressive injury of the fetal or immature brain. It causes movement deterioration and activity limitation. In CP patients increase in slow walking speed, shorter step length, and longer duration in the double support phase are common. Such gait changes are thought to reflect the unbalanced walking pattern seen in these children. Although children with CP are well known to have poor balance and high fall incidence, little effort has been made to quantify the dynamic walking stability of these children.
The Dynamic Gait Index (DGI) is a performance-based tool developed by Shumway-Cook and Woollacott to quantitatively measure dynamic balance capabilities. It also evaluates the individual's ability to modify gait in response to changing gait task requirements. Despite it's widespread use in the elderly population, DGI has not yet been investigated in children with neurological conditions. Considering that it takes a little time to apply the test, it may be advantageous for children in terms of simplicity and ease of administration.
In this study the investigators aim to validate and assess interrater and test - retest reliabilities of Turkish version of Dynamic Gait Index in children with unilateral, spastic cerebral palsy.
- Being tested
- Dynamic Gait Index
- 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.
Dynamic Gait IndexOther
Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Palsy Group | 16 patients will be included. Dynamic Gait Index and other assessments will be performed twice with a 7 - 10 day interval by two evaluators Receives: Other: Dynamic Gait Index | |
| Healthy Control Group | 16 healthy children will be included. Dynamic Gait Index and other assessments will be performed twice with a 7 - 10 day interval by two evaluators Receives: Other: Dynamic Gait Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Gait Index (DGI)
Dynamic Gait Index is a tool consisting eight items; gait on a flat surface, changing speed, gait with horizontal and vertical head turns, pivot turn, stepping over obstacle, Minimum score is 0, maximum score is 24, higher scores indicate better outcome. Scores lower than 19 indicate risk of falling and above 22 define safe ambulance.
Measured: Day 1 (Baseline) in both groups (Cerebral Palsy group same day by two different evaluators), Day 7-10 in the Cerebral Palsy group only
Secondary outcomes (3)
Pediatric Balance Scale (PBS)
Pediatric Balance Scale is a functional balance scale adapted and customized from Berg Balance Scale for use with children. Pediatric Balance Scale is a 14-item, criterion-referenced measure, which examines functional balance in the context of everyday tasks. It can easily be administered and scored in less than 20 minutes using equipment commonly found in schools and clinics. Scoring (0-4) is based on how long a specific movement or position is performed, how long the position can be maintained, or how much assistance it requires. Minimum score is 0, maximum score is 56; higher scores indicate better dynamic balance.
Measured: Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
Timed Up and Go Test (TUG)
TUG is a test determining fall risk and balance by their physical performance in sitting to standing, and walking. Test begins with the patient sitting back in a standart chair and when asked walking 10 feets on a certain line than back to the chair sitting. Completion time is recorded for the task and longer time indicates worse ambulation and higher risk of fall.
Measured: Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
Four Square Step Test (FSST)
FSST, assesses dynamic balance and coordination through stepping forwards, sideways, and backwards in a timed fashion. It is a valid and reliable tool in children with cerebral palsy. The test requires the participant to step forwards, backwards and sideways over four-square shaped line in a specified sequence. Completion time is recorded for the task and longer time indicates worse ambulation and higher risk of fall.
Measured: Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start1 Apr 2018
- Primary completion30 Jun 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naime Evrim Karadag Saygi, Prof, Study chair, Department of PM&R, Marmara University School of MedicineAyca Evkaya, PT, Principal investigator, Department of PM&R, Marmara University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662139
- Sponsor's protocol ID
- 02.04.2018-113
- Status last verified
- Nov 2019
- First submitted
- 5 Sep 2018
- Last updated
- 29 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.
PubMed 17057441Shumway-Cook A, Taylor CS, Matsuda PN, Studer MT, Whetten BK. Expanding the scoring system for the Dynamic Gait Index. Phys Ther. 2013 Nov;93(11):1493-506. doi: 10.2522/ptj.20130035. Epub 2013 Jun 27.
PubMed 23813090Bandong AN, Madriaga GO, Gorgon EJ. Reliability and validity of the Four Square Step Test in children with cerebral palsy and Down syndrome. Res Dev Disabil. 2015 Dec;47:39-47. doi: 10.1016/j.ridd.2015.08.012. Epub 2015 Aug 27.
PubMed 26318393Carey H, Martin K, Combs-Miller S, Heathcock JC. Reliability and Responsiveness of the Timed Up and Go Test in Children With Cerebral Palsy. Pediatr Phys Ther. 2016 winter;28(4):401-8. doi: 10.1097/PEP.0000000000000301.
PubMed 27661230Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
PubMed 17370477Evkaya A, Karadag-Saygi E, Karali Bingul D, Giray E. Validity and reliability of the Dynamic Gait Index in children with hemiplegic cerebral palsy. Gait Posture. 2020 Jan;75:28-33. doi: 10.1016/j.gaitpost.2019.09.024. Epub 2019 Sep 23.
PubMed 31590067
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Dynamic Gait Index in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03662139
- Acronym / sponsor ID
- 02.04.2018-113
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Posted 5 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess validity and reliability of Dynamic Gait Index (DGI) in patients with unilateral spastic cerebral palsy
Detailed description
Cerebral Palsy (CP) is a childhood onset, lifelong neurological disorder, attributed to non-progressive injury of the fetal or immature brain. It causes movement deterioration and activity limitation. In CP patients increase in slow walking speed, shorter step length, and longer duration in the double support phase are common. Such gait changes are thought to reflect the unbalanced walking pattern seen in these children. Although children with CP are well known to have poor balance and high fall incidence, little effort has been made to quantify the dynamic walking stability of these children.
The Dynamic Gait Index (DGI) is a performance-based tool developed by Shumway-Cook and Woollacott to quantitatively measure dynamic balance capabilities. It also evaluates the individual's ability to modify gait in response to changing gait task requirements. Despite it's widespread use in the elderly population, DGI has not yet been investigated in children with neurological conditions. Considering that it takes a little time to apply the test, it may be advantageous for children in terms of simplicity and ease of administration.
In this study the investigators aim to validate and assess interrater and test - retest reliabilities of Turkish version of Dynamic Gait Index in children with unilateral, spastic cerebral palsy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebral Palsy Group | – | Other: Dynamic Gait Index16 patients will be included. Dynamic Gait Index and other assessments will be performed twice with a 7 - 10 day interval by two evaluators |
| Healthy Control Group | – | Other: Dynamic Gait Index16 healthy children will be included. Dynamic Gait Index and other assessments will be performed twice with a 7 - 10 day interval by two evaluators |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 16 spastic unilateral cerebral palsy patients, between 6 - 14 years of age, and 16 healthy volunteer peers
Key inclusion criteria (4 listed)
- Confirmed diagnosis of spastic unilateral cerebral palsy
- Age between 4 - 16
- Able to stand and walk without any orthosis or special equipment
- Volunteer to study
Key exclusion criteria (6 listed)
- Being unable to walk
- Having cognitive disorder
- History of orthopedic surgery or any intervention for spasticity within the previous 12 months
- Uncontrolled epilepsy
- Visual conditions that prevent full participation to assessments
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 |
|---|---|---|
| Dynamic Gait IndexDynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions | Other | Cerebral Palsy Group, Healthy Control Group |
Primary outcome
Dynamic Gait Index (DGI)
Time frame: Day 1 (Baseline) in both groups (Cerebral Palsy group same day by two different evaluators), Day 7-10 in the Cerebral Palsy group only
Dynamic Gait Index is a tool consisting eight items; gait on a flat surface, changing speed, gait with horizontal and vertical head turns, pivot turn, stepping over obstacle, Minimum score is 0, maximum score is 24, higher scores indicate better outcome. Scores lower than 19 indicate risk of falling and above 22 define safe ambulance.
3 secondary outcomes
Pediatric Balance Scale (PBS)
Time frame: Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
Timed Up and Go Test (TUG)
Time frame: Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
Four Square Step Test (FSST)
Time frame: Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17057441Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.
- Background: PubMed 23813090Shumway-Cook A, Taylor CS, Matsuda PN, Studer MT, Whetten BK. Expanding the scoring system for the Dynamic Gait Index. Phys Ther. 2013 Nov;93(11):1493-506. doi: 10.2522/ptj.20130035. Epub 2013 Jun 27.
- Background: PubMed 26318393Bandong AN, Madriaga GO, Gorgon EJ. Reliability and validity of the Four Square Step Test in children with cerebral palsy and Down syndrome. Res Dev Disabil. 2015 Dec;47:39-47. doi: 10.1016/j.ridd.2015.08.012. Epub 2015 Aug 27.
- Background: PubMed 27661230Carey H, Martin K, Combs-Miller S, Heathcock JC. Reliability and Responsiveness of the Timed Up and Go Test in Children With Cerebral Palsy. Pediatr Phys Ther. 2016 winter;28(4):401-8. doi: 10.1097/PEP.0000000000000301.
- Background: PubMed 17370477Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
- Derived from this study: PubMed 31590067Evkaya A, Karadag-Saygi E, Karali Bingul D, Giray E. Validity and reliability of the Dynamic Gait Index in children with hemiplegic cerebral palsy. Gait Posture. 2020 Jan;75:28-33. doi: 10.1016/j.gaitpost.2019.09.024. Epub 2019 Sep 23.
- Individual participant dataSharing planned: Undecided
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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.
Naime Evrim Karadag Saygi, Prof study chair
Department of PM&R, Marmara University School of Medicine
Ayca Evkaya, PT principal investigator
Department of PM&R, Marmara University School of Medicine
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 and Hemiplegic Cerebral Palsy, run by Marmara 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 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 29 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?
Yes. Results are posted in the registry (first posted 5 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dynamic Gait Index (DGI) (time frame: Day 1 (Baseline) in both groups (Cerebral Palsy group same day by two different evaluators), Day 7-10 in the Cerebral Palsy group only). 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 NCT03662139, which also lists 6 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 29 Jan 2020.