NCT05213039

Brief Summary

Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder that starts in the early stages of life, causes activity limitation, and consists of movement and posture deficiencies. Children with CP usually have difficulties in mobility, transfer and social participation due to many motor and sensory disorders such as muscle weakness, decreased postural control, balance, spasticity. Many children with CP have difficulty in balancing independently, walking, walking on hills/uneven ground, and performing daily physical functions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

1.7 years

First QC Date

January 16, 2022

Last Update Submit

March 19, 2024

Conditions

Keywords

Cerebral Palsythe timed 360° turn testvalidityreliability

Outcome Measures

Primary Outcomes (5)

  • the timed 360° turn test

    In the timed 360° turn test, any marker, such as a tape or pen, is used to determine the starting point and a stopwatch is used to measure time. Each participant stands up comfortably at the starting point and rotates 360° for both sides. The time begins with the word "begin" and ends when the participants' shoulders look forward again. Each participant completes. The average of 3 trials and 3 trials for each side yields a result. The average score is recorded for the timed 360° turn test performance.

    two different observers' measurements in 2 different days (2 sessions per day on two separate days)

  • Four Square Step Test (FSST)

    The child stands in square 2 facing square 1 in a marked area divided into 4 squares. The child has to take turns stepping on each square as fast as possible: it requires the child to step forward, backward, right, and left in a sequence of 2, 3, 4, 1, 4, 3, 2, and 1, respectively. The necessary equipment is a stopwatch and 4 walking sticks 90 cm long. A square with 4 is formed by laying the canes flat on the ground. If the child cannot complete the series, loses balance or touches the cane during the trial, the trial is repeated.Two FSSTs are completed with the best time taken as a score.Timing begins with the first foot touching the floor in frame 1 and ends with the last foot touching the floor in frame 4. Test performance is measured in seconds (sec) and shorter completion time means better dynamic stability.

    first day of assessment

  • Pediatric Berg Balance Scale (PBBS)

    The test has 14 items of increasing difficulty to test functional skills related to activities of daily living, from sitting to standing on one leg. Each item is scored on a five-point ranking scale ranging from 0 to 4 points, with a maximum score level of 56. A higher score indicates better postural balance.

    first day of assesment

  • Timed Up and Go Test (TUG)

    For the test, the child is seated in a height-adjustable chair. The chair height is adjusted so that the child's feet are in contact with the floor and the knees and hips are flexed to 90 degrees. A distance of 3 meters is marked. When the command is given, the child is asked to get up, walk, return and sit on the chair until the marked area. By starting the time with the start command, the time until sitting is recorded. This test will be repeated 3 times and the average time will be recorded. Increasing time indicates worse dynamic stability.

    first day of assesment

  • Pediatric Functional Reach test

    The child is asked to stand sideways on a wall, with the elbows extended at 90 degrees of shoulder flexion without touching the wall. The first measurement is made in this position. Then, he is asked to reach forward without taking a step. The last point it can reach is recorded. The distance between these two distances is measured in meters and recorded. The test is repeated when stepping or stopping the contact of the foot with the ground. A higher measurement indicates worse balance.

    first day of assesment

Secondary Outcomes (3)

  • Expanded and revised Gross Motor Function Classification System (GMFCS-E&R)

    first day of assessment

  • Modified Ashworth Scale (MASH)

    first day of assessment

  • Demographic information of the children

    first day of assessment

Study Arms (1)

1/Children with diparetic and hemiparetic cerebral palsy

1/Children with diparetic and hemiparetic cerebral palsy whose Gross Motor Function Classification System (GMFCS) Level ≤ 2 will be evaulated by two different observers.

Other: assessments

Interventions

All of the children with cerebral palsy will be assessed by two different physiotherapist observers. The timed 360° turn test, Expanded and revised Gross Motor Function Classification System (GMFCS-E\&R) for functional motor levels of the subjects, lower extremity muscle tone will be measured with the Modified Ashworth Scale (MASH) at the beginning of the one-time study and recorded. Pediatric Berg Balance Scale, Timed Up and Go Test, Pediatric Functional Reaching test and Modified Four Square Stepping Test, 3m walking back test (3MGYT) will be performed.Evaluations will be made by two separate physiotherapists with at least 5 years of experience in this field. The time it took for individuals to complete activities during the tests with a stopwatch will be recorded.

Also known as: the timed 360° turn test
1/Children with diparetic and hemiparetic cerebral palsy

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

children with spastic diparetic and hemiparetic cerebral palsy

You may qualify if:

  • Having been diagnosed with CP according to SCPE criteria
  • Level ≤ 2 by GMFCS-E\&R
  • Children aged 7-18 with CP with a Communication Function Classification System (CFCS) ≤ 3
  • Children with a Modified Ashworth Scale (MASH) ≤ 3
  • Passive range of motion in the ankle, knee and hip joints
  • Individuals with spastic hemiparetic-diparetic CP who can follow verbal commands
  • Volunteer to participate in the study

You may not qualify if:

  • Have not had Botox, (Botulinum toxin) or surgery in the last 6 months
  • Contracture of ankle and knee joint
  • Individuals with hemiparetic-diparetic CP who can follow verbal commands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • hatice adıgüzel, PhD

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Proffessor

Study Record Dates

First Submitted

January 16, 2022

First Posted

January 28, 2022

Study Start

July 15, 2022

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations