Trial Outcomes & Findings for Dynamic Gait Index in Hemiplegic Cerebral Palsy (NCT NCT03662139)
NCT ID: NCT03662139
Last Updated: 2020-01-29
Results Overview
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.
COMPLETED
32 participants
Day 1 (Baseline) in both groups (Cerebral Palsy group same day by two different evaluators), Day 7-10 in the Cerebral Palsy group only
2020-01-29
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cerebral Palsy Group
n=16 Participants
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
|
Healthy Control Group
n=16 Participants
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
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.31 years
STANDARD_DEVIATION 2.62 • n=16 Participants
|
9.75 years
STANDARD_DEVIATION 2.51 • n=16 Participants
|
10.03 years
STANDARD_DEVIATION 2.55 • n=32 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=16 Participants
|
8 Participants
n=16 Participants
|
13 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=16 Participants
|
8 Participants
n=16 Participants
|
19 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Height
|
142 cm
STANDARD_DEVIATION 15 • n=16 Participants
|
140 cm
STANDARD_DEVIATION 13 • n=16 Participants
|
141 cm
STANDARD_DEVIATION 14 • n=32 Participants
|
|
Body weight
|
38.43 kg
STANDARD_DEVIATION 10.85 • n=16 Participants
|
38.87 kg
STANDARD_DEVIATION 11.63 • n=16 Participants
|
38.65 kg
STANDARD_DEVIATION 11.07 • n=32 Participants
|
|
BMI
|
18.56 kg/m^2
STANDARD_DEVIATION 3.12 • n=16 Participants
|
19.40 kg/m^2
STANDARD_DEVIATION 3.23 • n=16 Participants
|
18.98 kg/m^2
STANDARD_DEVIATION 3.16 • n=32 Participants
|
|
Gestational week
|
35.12 weeks
STANDARD_DEVIATION 4.22 • n=16 Participants
|
37.25 weeks
STANDARD_DEVIATION 2.38 • n=16 Participants
|
36.19 weeks
STANDARD_DEVIATION 3.54 • n=32 Participants
|
|
Birth weight (kg)
|
2.52 kg
STANDARD_DEVIATION 0.78 • n=16 Participants
|
3.03 kg
STANDARD_DEVIATION 0.67 • n=16 Participants
|
2.77 kg
STANDARD_DEVIATION 0.76 • n=32 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) in both groups (Cerebral Palsy group same day by two different evaluators), Day 7-10 in the Cerebral Palsy group onlyPopulation: Cerebral palsy group is assessed 2 times in a 7-10 days period for the test-retest reliability. Control group is assessed only once.
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.
Outcome measures
| Measure |
Cerebral Palsy Group
n=16 Participants
16 patients 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
|
Healthy Control Group
n=16 Participants
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
|
|---|---|---|
|
Dynamic Gait Index (DGI)
1. Assessment
|
19 units on a scale
Interval 8.0 to 23.0
|
24 units on a scale
Interval 23.0 to 24.0
|
|
Dynamic Gait Index (DGI)
2. Assessment
|
18.5 units on a scale
Interval 10.0 to 23.0
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cerebral Palsy Group
n=16 Participants
16 patients 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
|
Healthy Control Group
n=16 Participants
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
|
|---|---|---|
|
Pediatric Balance Scale (PBS)
1. Assessment
|
49.5 units on a scale
Interval 39.0 to 54.0
|
56 units on a scale
Interval 53.0 to 56.0
|
|
Pediatric Balance Scale (PBS)
2. Assessment
|
50 units on a scale
Interval 39.0 to 54.0
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cerebral Palsy Group
n=16 Participants
16 patients 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
|
Healthy Control Group
n=16 Participants
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
|
|---|---|---|
|
Timed Up and Go Test (TUG)
1. Assessment
|
10 seconds
Interval 5.87 to 16.22
|
6.97 seconds
Interval 5.15 to 8.42
|
|
Timed Up and Go Test (TUG)
2. Assessment
|
8.72 seconds
Interval 6.16 to 14.23
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cerebral Palsy Group
n=16 Participants
16 patients 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
|
Healthy Control Group
n=16 Participants
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
|
|---|---|---|
|
Four Square Step Test (FSST)
1. Assessment
|
11.85 seconds
Interval 8.35 to 40.38
|
7.33 seconds
Interval 6.25 to 10.2
|
|
Four Square Step Test (FSST)
2. Assessment
|
10.21 seconds
Interval 7.42 to 38.42
|
—
|
Adverse Events
Cerebral Palsy Group
Healthy Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Naime Evrim Karadag-Saygi, Prof. Dr.
Department of PM&R, Marmara University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place