Relationships Between OLST, GMFM and Pedobarographic Values in CP
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
one leg standing test, gross motor function measurement, pedobarographic measurement
Sponsored by
About this trial
This is an interventional basic science trial for Cerebral Palsy focused on measuring cerebral palsy,, gait,, Gross Motor Function Measurement,, stability,, foot pressure
Eligibility Criteria
Inclusion Criteria (for experimental group):
- diagnosed unilateral cerebral palsy
- be able to stand on the affected leg for 0 to 30 seconds
Exclusion Criteria:
- Children with UCP who had Botulinum Toxin-A injections to the lower limbs in the previous six months
- Lower limb surgeries
- Mental disorders
Sites / Locations
- Istanbul Kültür University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
UCP Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
One leg standing test (OLST)
During the OLST, the participants were asked to shoes off, place both hands on their hips and look at a point on the wall at eye level. A recording stopwatch was used to assess their standing duration on one leg while keeping the other leg in 90 degrees of knee flexion. The test was stopped when the contralateral foot touched the ground or when the participant broke 90 degrees of knee flexion. The OLST was repeated three times for each leg and the best score was chosen.
Gross Motor Function Measurement (GMFM)
The Gross Motor Function Measure (GMFM) is an assessment tool designed and evaluated to measure changes in gross motor function over time or with intervention in children with cerebral palsy. Items span the spectrum of gross motor activities in five dimensions.
A: Lying and Rolling,
B: Sitting,
C: Crawling and Kneeling,
D: Standing, and
E: Walking, Running and Jumping. In our study, To assess standing and walking, running and jumping functions of the UCP group (GMFCs level I and II), the D and E dimensions of GMFM were utilized by a certificated physiotherapist. Each item was tested by three trials and the best trial was scoring between 0-3 points.
Pedobarographic Measurement
The participants' plantar pressure was analyzed using pedobarography (Tekscan Inc. Mass. USA) with rectangular shape plates (43.59 x 36.88 x 5.77 cm) and 2288 resistive pressure sensors. For each participant, the pedobarography was calibrated before the assessment. During the pedobarographic analysis, the participants walked barefoot in 90 BPM cadence with the aid of a metronome. Before the pedobarographic analysis, each participant walked three minutes to adapt to the metronome.Three steps were analyzed for each side (affected and unaffected sides) to evaluate the following parameters i) time of peak force in early stance phase (T1), ii) time of peak force of late stance phase (T2), iii) stance phase stability (T2-T1), iv) duration of total stance phase (TS) and v) ratio (T2-T1/TS). A mean value of each parameter was used for statistical analysis.
Secondary Outcome Measures
Full Information
NCT ID
NCT04273204
First Posted
February 11, 2020
Last Updated
February 13, 2020
Sponsor
Istanbul Kültür University
Collaborators
Istanbul University
1. Study Identification
Unique Protocol Identification Number
NCT04273204
Brief Title
Relationships Between OLST, GMFM and Pedobarographic Values in CP
Official Title
Does One-Leg-Standing Duration Have a Relationship With Gross Motor Function Measurement Scores and Stance Phase for Unilateral Spastic Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
March 15, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Kültür University
Collaborators
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim of this study was to investigate the relationship between the One Leg-Standing Test (OLST) and the Gross Motor Function Measurement (GMFM) and stance phase stability during gait in Unilateral Cerebral Palsy (UCP). The secondary aim was to explore a new well-defined pedobarographic parameter as a functional factor in the stability of stance in gait.
The investigator's hypotheses are (1) OLST has relationship between T2-T1 in children with UCP; (2) OLST has relationship between GMFM D and E.
Eighteen children with UCP and ten typically developing children (TDC) participated in the study. All participants and their legal guardians signed an informed consent form before participating. Firstly, to asses the stability in stance all participants were analyzed by using pedobarographic analysis and the OLST. After analysis, only the UCP group was evaluated with the GMFM. The TDC group was used for comparison of pedobarographic stance phase stability (T2-T1) and OLST values.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy,, gait,, Gross Motor Function Measurement,, stability,, foot pressure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UCP Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
one leg standing test, gross motor function measurement, pedobarographic measurement
Intervention Description
OLST:During the OLST,the participants were asked to shoes off,place both hands on their hips and look at a point on the wall at eye level.A recording stopwatch was used to assess their standing duration on one leg while keeping the other leg in 90 degrees of knee flexion.The test was stopped when the contralateral foot touched the ground or when the participant broke 90 degrees of knee flexion.The OLST was repeated three times for each leg.GMFM:To assess standing and walking,running and jumping functions of the UCP group,the D and E dimensions of GMFM were utilized by a certificated physiotherapist.Each item was tested by three trials and the best trial was used.Pedobarography:The participants' plantar pressure was analyzed using pedobarography.For each participant, the pedobarography was calibrated before the assessment.During the pedobarographic analysis, the participants walked barefoot in 90 BPM cadence. Three steps were analyzed for each side.
Primary Outcome Measure Information:
Title
One leg standing test (OLST)
Description
During the OLST, the participants were asked to shoes off, place both hands on their hips and look at a point on the wall at eye level. A recording stopwatch was used to assess their standing duration on one leg while keeping the other leg in 90 degrees of knee flexion. The test was stopped when the contralateral foot touched the ground or when the participant broke 90 degrees of knee flexion. The OLST was repeated three times for each leg and the best score was chosen.
Time Frame
1 time, baseline of the study
Title
Gross Motor Function Measurement (GMFM)
Description
The Gross Motor Function Measure (GMFM) is an assessment tool designed and evaluated to measure changes in gross motor function over time or with intervention in children with cerebral palsy. Items span the spectrum of gross motor activities in five dimensions.
A: Lying and Rolling,
B: Sitting,
C: Crawling and Kneeling,
D: Standing, and
E: Walking, Running and Jumping. In our study, To assess standing and walking, running and jumping functions of the UCP group (GMFCs level I and II), the D and E dimensions of GMFM were utilized by a certificated physiotherapist. Each item was tested by three trials and the best trial was scoring between 0-3 points.
Time Frame
1 time, baseline of the study
Title
Pedobarographic Measurement
Description
The participants' plantar pressure was analyzed using pedobarography (Tekscan Inc. Mass. USA) with rectangular shape plates (43.59 x 36.88 x 5.77 cm) and 2288 resistive pressure sensors. For each participant, the pedobarography was calibrated before the assessment. During the pedobarographic analysis, the participants walked barefoot in 90 BPM cadence with the aid of a metronome. Before the pedobarographic analysis, each participant walked three minutes to adapt to the metronome.Three steps were analyzed for each side (affected and unaffected sides) to evaluate the following parameters i) time of peak force in early stance phase (T1), ii) time of peak force of late stance phase (T2), iii) stance phase stability (T2-T1), iv) duration of total stance phase (TS) and v) ratio (T2-T1/TS). A mean value of each parameter was used for statistical analysis.
Time Frame
1 time, baseline of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (for experimental group):
diagnosed unilateral cerebral palsy
be able to stand on the affected leg for 0 to 30 seconds
Exclusion Criteria:
Children with UCP who had Botulinum Toxin-A injections to the lower limbs in the previous six months
Lower limb surgeries
Mental disorders
Facility Information:
Facility Name
Istanbul Kültür University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Relationships Between OLST, GMFM and Pedobarographic Values in CP
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