Cerebral Palsy, Gait Disorders, Neurologic, Hemiplegic Cerebral Palsy
Conditions
Brief summary
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.
Interventions
OTHERDynamic Gait Index
Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions
Sponsors
Marmara University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Gait Index (DGI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Balance Scale (PBS) | Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators) | 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. |
| Timed Up and Go Test (TUG) | Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators) | 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. |
| Four Square Step Test (FSST) | Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators) | 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. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| 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 | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Cerebral Palsy Group | Healthy Control Group | Total |
|---|---|---|---|
| Age, Continuous | 10.31 years STANDARD_DEVIATION 2.62 | 9.75 years STANDARD_DEVIATION 2.51 | 10.03 years STANDARD_DEVIATION 2.55 |
| Birth weight (kg) | 2.52 kg STANDARD_DEVIATION 0.78 | 3.03 kg STANDARD_DEVIATION 0.67 | 2.77 kg STANDARD_DEVIATION 0.76 |
| BMI | 18.56 kg/m^2 STANDARD_DEVIATION 3.12 | 19.40 kg/m^2 STANDARD_DEVIATION 3.23 | 18.98 kg/m^2 STANDARD_DEVIATION 3.16 |
| Body weight | 38.43 kg STANDARD_DEVIATION 10.85 | 38.87 kg STANDARD_DEVIATION 11.63 | 38.65 kg STANDARD_DEVIATION 11.07 |
| Gestational week | 35.12 weeks STANDARD_DEVIATION 4.22 | 37.25 weeks STANDARD_DEVIATION 2.38 | 36.19 weeks STANDARD_DEVIATION 3.54 |
| Height | 142 cm STANDARD_DEVIATION 15 | 140 cm STANDARD_DEVIATION 13 | 141 cm STANDARD_DEVIATION 14 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 13 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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.
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
Population: Cerebral palsy group is assessed 2 times in a 7-10 days period for the test-retest reliability. Control group is assessed only once.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cerebral Palsy Group | Dynamic Gait Index (DGI) | 1. Assessment | 19 units on a scale |
| Cerebral Palsy Group | Dynamic Gait Index (DGI) | 2. Assessment | 18.5 units on a scale |
| Healthy Control Group | Dynamic Gait Index (DGI) | 1. Assessment | 24 units on a scale |
Comparison: Between group differencep-value: <0.01Wilcoxon (Mann-Whitney)
Comparison: Test - Retest Reliability (Difference between 1st and 2nd assessments in Cerebral Palsy group)p-value: <0.0595% CI: [0.915, 0.99]Intraclass Correlation Coefficient(ICC)
Comparison: Interrater Reliability (Difference between 1st and 2nd evaluators in Cerebral Palsy group)p-value: <0.0195% CI: [0.882, 0.998]Intraclass Correlation Coefficient(ICC)
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.
Time frame: Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
Population: Cerebral palsy group is assessed 2 times in a 7-10 days period for the test-retest reliability. Control group is assessed only once.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cerebral Palsy Group | Four Square Step Test (FSST) | 1. Assessment | 11.85 seconds |
| Cerebral Palsy Group | Four Square Step Test (FSST) | 2. Assessment | 10.21 seconds |
| Healthy Control Group | Four Square Step Test (FSST) | 1. Assessment | 7.33 seconds |
Comparison: Between group differencep-value: <0.01Wilcoxon (Mann-Whitney)
Comparison: Correlation between Dynamic Gait Index (DGI) and Four Square Step Test (FSST) scores in Cerebral Palsy group.p-value: <0.05Spearman's Correlation Test
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.
Time frame: Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
Population: Cerebral palsy group is assessed 2 times in a 7-10 days period for the test-retest reliability. Control group is assessed only once.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cerebral Palsy Group | Pediatric Balance Scale (PBS) | 2. Assessment | 50 units on a scale |
| Cerebral Palsy Group | Pediatric Balance Scale (PBS) | 1. Assessment | 49.5 units on a scale |
| Healthy Control Group | Pediatric Balance Scale (PBS) | 1. Assessment | 56 units on a scale |
Comparison: Between group differencep-value: <0.01Wilcoxon (Mann-Whitney)
Comparison: Correlation between Dynamic Gait Index (DGI) and Pediatric Balance Scale (PBS) scores in Cerebral Palsy groupp-value: <0.05Spearman's Correlation Test
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.
Time frame: Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)
Population: Cerebral palsy group is assessed 2 times in a 7-10 days period for the test-retest reliability. Control group is assessed only once.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cerebral Palsy Group | Timed Up and Go Test (TUG) | 1. Assessment | 10 seconds |
| Cerebral Palsy Group | Timed Up and Go Test (TUG) | 2. Assessment | 8.72 seconds |
| Healthy Control Group | Timed Up and Go Test (TUG) | 1. Assessment | 6.97 seconds |
Comparison: Between group differencep-value: <0.01Wilcoxon (Mann-Whitney)
Comparison: Correlation between Dynamic Gait Index (DGI) and Timed Up and Go Test (TUG) scores in Cerebral Palsy groupp-value: <0.01Spearman's Correlation Test