Validity and Reliability of the the Timed 360° Turn Test (cp)

March 19, 2024 updated by: Hatice Adiguzel, Kahramanmaras Sutcu Imam University

Validity and Reliability of the Timed 360° Turn Test in Children With Cerebral Palsy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Abnormal gait patterns and balance problems are common problems in children with CP. As children get older, these impairments in walking abilities become more pronounced. In addition to all these problems, hypertonus, increased stretch reflex, muscle weakness, coactivation of antagonist muscles, posture disorders, proprioception losses, muscle and joint deformities are other factors that cause gait disorders and balance problems in children with CP. At this point, the main purpose of CP rehabilitation is to ensure that the child gains maximum functional independence by achieving optimal developmental potential. Therefore, balance and gait restrictions are important problems in children with CP. For these reasons, the evaluation of gait and balance is of great importance in terms of determining the effectiveness of the physiotherapy program, shaping the program, planning and determining the effectiveness of orthopedic and surgical applications, especially in children with CP who have walking potential. In the literature, gait pathologies in children with CP and easy-to-use, valid and reliable observational gait analyzes that can evaluate gait in the clinic are emphasized.Gait analysis systems including computerized kinetics and kinematics laboratories, electromyography (EMG) and video imaging are the "gold standard" methods used to evaluate the gait of children with CP. However, these evaluation methods are not routinely used in clinics because they are complex, expensive, time-consuming and not easy to apply. In addition to many gait assessment scales, the standing, walking, running and stair climbing sections of Gross Motor Function Measurement (GMFM) are widely used in the clinic to evaluate gait. In addition to all these, performance tests that are commonly used in the clinic, such as the Timed Sit and Go Test, the Up and Down Stair Climbing Test, the 2 Minute Walk Test, and the 6 Minute Walk Test, evaluate the functionality of gait. All these tests are tests that evaluate gait prospectively and cannot fully address the functional status of the child. Therefore, in order to gain and maintain functional independence, the gait problems of the child with CP need to be examined more. In this respect, it provides a different task than normal with the evaluation of rotation, allowing the observation of body perception, trunk stability, balance, correction and protective reactions provided by anterior-posterior cocontraction. This observation can provide the exact determination of the problem that will guide the treatment. The timed 360° turn test is a standard clinical measure used to evaluate dynamic standing balance. When the literature was reviewed, no study was found about the The timed 360° turn test in children with CP. The aim of the study is to examine the validity and reliability of The timed 360° turn test in children with CP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Kahramanmaras, Turkey, 46100
        • Kahramanmaras Sutcu Imam University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

children with spastic diparetic and hemiparetic cerebral palsy

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Other Names:
  • the timed 360° turn test

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the timed 360° turn test
Time Frame: two different observers' measurements in 2 different days (2 sessions per day on two separate days)
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)
Time Frame: first day of assessment
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)
Time Frame: first day of assesment
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)
Time Frame: first day of assesment
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
Time Frame: first day of assesment
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Expanded and revised Gross Motor Function Classification System (GMFCS-E&R)
Time Frame: first day of assessment
It is a standard classification system used to classify gross motor functions of children with CP. GMFCS-E&R classifies levels I to V. Level I indicates the best and V the worst level of motor function.
first day of assessment
Modified Ashworth Scale (MASH)
Time Frame: first day of assessment
It is a method used to determine the severity of spasticity. It is based on the subjective rating of the resistance felt during the examination. Spasticity of the bilateral hip adductors, hip flexors, knee flexors, ankle plantar flexors (gastro-solues) muscles in the lower extremity will be evaluated once at the beginning of the treatment program. The tone felt in these muscles against passive movement is classified as follows; 0: No increase in tone, 1: Slight increase in tone characterized by catching and relaxation or mild resistance at the end of the ROM, 1+: Slight increase in tone characterized by minimal resistance in the remaining ROM (less than half) after capture, 2: Significant tone over most of the ROM increase, but the involved joint can be moved easily, 3: Significant increase in muscle tone, passive movement is difficult, 4: The involved part is rigid in flexion or extension.
first day of assessment
Demographic information of the children
Time Frame: first day of assessment
age, height, gender, education level, background of physiotherapy and diagnosis will be recorded.
first day of assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kahramanmaras Sutcu Imam University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: hatice adıgüzel, PhD, Kahramanmaras Sutcu Imam University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KSUFTR1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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