Relationships Between OLST, GMFM and Pedobarographic Values in CP

Sponsor

Istanbul Kültür University (Other)

Overall Status

Completed

CT.gov ID

NCT04273204

Collaborator

Istanbul University (Other)

Enrollment

Location

Arms

8.6

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy	Diagnostic Test: one leg standing test, gross motor function measurement, pedobarographic measurement	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Does One-Leg-Standing Duration Have a Relationship With Gross Motor Function Measurement Scores and Stance Phase for Unilateral Spastic Children

Actual Study Start Date :

Jan 10, 2018

Actual Primary Completion Date :

Mar 15, 2018

Actual Study Completion Date :

Sep 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UCP Group	Diagnostic Test: one leg standing test, gross motor function measurement, pedobarographic measurement 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.
Other: Control Group	Diagnostic Test: one leg standing test, gross motor function measurement, pedobarographic measurement 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.

Arm

Intervention/Treatment

Experimental: UCP Group

Diagnostic Test: one leg standing test, gross motor function measurement, pedobarographic measurement

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.

Other: Control Group

Diagnostic Test: one leg standing test, gross motor function measurement, pedobarographic measurement

Outcome Measures

Primary Outcome Measures

One leg standing test (OLST) [1 time, baseline of the study]
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) [1 time, baseline of the study]
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 [1 time, baseline of the study]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Kültür University	Istanbul		Turkey

Sponsors and Collaborators

Istanbul Kültür University
Istanbul University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gamze Ertürk, Research assistant, Istanbul Kültür University

ClinicalTrials.gov Identifier:

NCT04273204

Other Study ID Numbers:

2017/397

First Posted:

Feb 18, 2020

Last Update Posted:

Feb 18, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gamze Ertürk, Research assistant, Istanbul Kültür University

cerebral palsy,

gait,

Gross Motor Function Measurement,

stability,

foot pressure

Additional relevant MeSH terms:

Cerebral Palsy

Study Results

No Results Posted as of Feb 18, 2020