NCT05229523

Brief Summary

Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder that causes activity limitation resulting from movement and posture deficiencies as a result of a lesion in the immature brain. 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.Hypertonus and abnormal motor patterns, lack of trunk control and postural disorders adversely affect the physical development of these children. Children with CP show various posture disorders due to proximal muscle strength losses leading to limitations and deficiencies in postural reactions. This leads to losses in reactive and antisipatory postural adjustments, and limits upper extremity functions such as walking, reaching, and eating. For this reason, children with CP have difficulties in maintaining balance while standing or sitting independently, walking, maintaining postural control in various environments such as walking, hills/uneven floors, performing activities of daily living (ADL) and social participation.

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 May 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 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 PalsygaitModified Four Square Step Test (mFSST)reliabilityvalidity

Outcome Measures

Primary Outcomes (8)

  • Modified Four Square Step Test (mFSST)

    It aims to assess dynamic balance and step objects forward, sideways and backwards. The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and it is written up to 4 in a clockwise direction. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then back to the number (4). He is then asked to take steps from 4 to 1 again. The time is recorded. High time indicates worse dynamic stability.

    day 1 (observer1)

  • Modified Four Square Step Test (mFSST)

    It aims to assess dynamic balance and step objects forward, sideways and backwards. The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and it is written up to 4 in a clockwise direction. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then back to the number (4). He is then asked to take steps from 4 to 1 again. The time is recorded. High time indicates worse dynamic stability.

    day 1 (observer2)

  • Modified Four Square Step Test (mFSST)

    It aims to assess dynamic balance and step objects forward, sideways and backwards. The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and it is written up to 4 in a clockwise direction. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then back to the number (4). He is then asked to take steps from 4 to 1 again. The time is recorded. High time indicates worse dynamic stability.

    day 2 (observer2)

  • Modified Four Square Step Test (mFSST)

    It aims to assess dynamic balance and step objects forward, sideways and backwards. The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and it is written up to 4 in a clockwise direction. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then back to the number (4). He is then asked to take steps from 4 to 1 again. The time is recorded. High time indicates worse dynamic stability.

    day 2 (observer1)

  • 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.

    day 1 (observer1)

  • Timed Up and Go Test (TUG)

    It is a reliable test that measures walking speed, postural control, functional mobility and balance. 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 balance.

    day 1 (observer1)

  • Pediatric Functional Reach test (PFRT)

    Necessary environmental conditions are provided away from external stimuli. Then, the child is asked to stand sideways on a wall, with the elbows extended in 90 degrees 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. Increasing the measured distance indicates worse balance.

    day 1 (observer1)

  • Four Square Stepping 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 fails to complete the series, loses balance, or touches the cane during the trial, the trial is repeated. 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.

    day 1 (observer1)

Secondary Outcomes (2)

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

    day 1 (observer1)

  • Modified Ashworth Scale (MAS)

    day 1 (observer1)

Study Arms (1)

1/Children with diparetic and hemiparetic cerebral palsy

1/Children with diparetic and hemiparetic cerebral palsy aged 7-18 years with the Communication Function Classification System (CFCS) level ≤ 3 and Extended Gross Motor Function Classification System (GMFCS-E\&R) level ≤ 2

Other: repeated assessments

Interventions

validity and reliability of the Modified Four Square Step Test (mFSST) in children with cerebral palsy with the tests of Pediatric Berg Balance Scale (PBSS), Timed Up and Go Test (TUG), Pediatric Functional Reaching Test (PFUT)

Also known as: validity and reliability of the Modified Four Square Step Test (mFSST) in children with cerebral palsy
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:

  • Diagnosed with CP according to SCPE criteria
  • Expanded Gross Motor Function Classification System (GMFCS-E\&R) Level ≤ 2
  • 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:

  • Not having 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

February 8, 2022

Study Start

May 15, 2022

Primary Completion

January 15, 2024

Study Completion

January 15, 2024

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations