Relationships Between OLST, GMFM and Pedobarographic Values in CP

NCT ID: NCT04273204

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2018-09-30

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

UCP Group

Group Type: EXPERIMENTAL

one leg standing test, gross motor function measurement, pedobarographic measurement

Intervention Type: DIAGNOSTIC_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.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.

Control Group

Group Type: OTHER

one leg standing test, gross motor function measurement, pedobarographic measurement

Intervention Type: DIAGNOSTIC_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.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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University

OTHER

Sponsor Role: collaborator

Istanbul Kültür University

OTHER

Sponsor Role: lead

Responsible Party

Gamze Ertürk

Research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Kültür University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2017/397

Identifier Type: -

Identifier Source: org_study_id