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The purpose of this study is to assess validity and reliability of Dynamic Gait Index (DGI) in patients with unilateral spastic cerebral palsy
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Gait Index | Other | Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 (Baseline) in both groups (Cerebral Palsy group same day by two different evaluators), Day 7-10 in the Cerebral Palsy group only |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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16 spastic unilateral cerebral palsy patients, between 6 - 14 years of age, and 16 healthy volunteer peers
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| Name | Affiliation | Role |
|---|---|---|
| Naime Evrim Karadag Saygi, Prof | Department of PM&R, Marmara University School of Medicine | Study Chair |
| Ayca Evkaya, PT | Department of PM&R, Marmara University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation | Istanbul | 34899 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17057441 | Background | 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. | |
| 23813090 | Background | Shumway-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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cerebral Palsy Group | 16 patients with hemiplegic cerebral palsy will be included. Dynamic Gait Index and other assessments will be performed twice with a 7 - 10 day interval by two evaluators Dynamic Gait Index: Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions |
| FG001 | 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 Dynamic Gait Index: Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cerebral Palsy Group | 16 patients with hemiplegic cerebral palsy will be included. Dynamic Gait Index and other assessments will be performed twice with a 7 - 10 day interval by two evaluators Dynamic Gait Index: Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Cerebral palsy group is assessed 2 times in a 7-10 days period for the test-retest reliability. Control group is assessed only once. | Posted | Median | Full Range | units on a scale | Day 1 (Baseline) in both groups (Cerebral Palsy group same day by two different evaluators), Day 7-10 in the Cerebral Palsy group only |
|
7 - 10 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cerebral Palsy Group | 16 patients with hemiplegic cerebral palsy will be included. Dynamic Gait Index and other balance assessments will be performed twice with a 7 - 10 day interval by two evaluators |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naime Evrim Karadag-Saygi, Prof. Dr. | Department of PM&R, Marmara University School of Medicine | 00902166570606 | 1628 | evrimkaradag4@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 2, 2018 | Oct 1, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 2, 2018 | Oct 1, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. | 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. | Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators) |
| 26318393 | Background | Bandong 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. |
| 27661230 | Background | Carey 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. |
| 17370477 | Background | Rosenbaum 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. |
| 31590067 | Derived | Evkaya 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. |
| BG001 |
| 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 Dynamic Gait Index: Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Body weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Gestational week | Mean | Standard Deviation | weeks |
|
| Birth weight (kg) | Mean | Standard Deviation | kg |
|
| OG001 | 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 Dynamic Gait Index: Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions |
|
|
|
| Secondary | 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. | Cerebral palsy group is assessed 2 times in a 7-10 days period for the test-retest reliability. Control group is assessed only once. | Posted | Median | Full Range | units on a scale | Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators) |
|
|
|
|
| Secondary | 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. | Cerebral palsy group is assessed 2 times in a 7-10 days period for the test-retest reliability. Control group is assessed only once. | Posted | Median | Full Range | seconds | Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators) |
|
|
|
|
| Secondary | 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. | Cerebral palsy group is assessed 2 times in a 7-10 days period for the test-retest reliability. Control group is assessed only once. | Posted | Median | Full Range | seconds | Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators) |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Healthy Control Group | 16 healthy children will be included. Dynamic Gait Index and other balance assessments will be performed twice with a 7 - 10 day interval by two evaluators | 0 | 16 | 0 | 16 | 0 | 16 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 2. Assessment |
|
|
The level of relationship was classified as follows <0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; >0.90=very high. |
| <0.05 |
| Spearman's correlation coefficient (rs) |
| 0.724 |
| 2-Sided |
| Superiority |
| 2. Assessment |
|
|
| <0.01 |
| Spearman's correlation coefficient (rs) |
| -0.828 |
| 2-Sided |
The level of relationship was classified as follows <0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; >0.90=very high. |
| Superiority |
| 2. Assessment |
|
|
| <0.05 |
| Spearman's correlation coefficient (rs) |
| -0.673 |
| 2-Sided |
The level of relationship was classified as follows <0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; >0.90=very high. |
| Superiority |