NCT06697704

Brief Summary

This observational study aims to investigate the relationship between trunk somatosensory function, trunk control, and thoracic kyphosis in children with cerebral palsy. The main questions it seeks to answer are:

  • Is there a relationship between trunk somatosensory function and trunk control?
  • Is there a relationship between trunk somatosensory function and thoracic kyphosis?
  • Is there a relationship between trunk control and thoracic kyphosis?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

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

March 15, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 22, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

March 15, 2024

Last Update Submit

November 19, 2024

Conditions

Keywords

cerebral palsytrunk controlspinal curvaturesomatosensory function

Outcome Measures

Primary Outcomes (7)

  • Light Touch, Tactile Sense

    A measure of trunk somatosensory function, using a Semmes-Weinstein Monofilament (SWM) kit, consisting of 20 calibrated monofilaments in the prone position.

    At baseline

  • Two-Point Discrimination, Tactile Sense

    A measure of trunk somatosensory function, using a discriminator in the prone position.

    At baseline

  • Vibration, Tactile Sense

    A measure of trunk somatosensory function, using a 64 Hz tuning fork in the prone position.

    At baseline

  • Position Sense Reproduction, Proprioception Sense

    A measure of trunk somatosensory function, using a digital inclinometer in a comfortable position with their hips and knees flexed to 90 degrees in the sitting position for the 30 degree trunk flexion and 10 degree trunk extension.

    At baseline

  • Pain Sense

    A measure of trunk somatosensory function, using a dolorimeter for the pressure pain threshold in the prone position and the Visual Analogue Scale (VAS) for the pain severity.

    At baseline

  • Trunk Control

    It was evaluated by the Trunk Control Measurement Scale (TCMS). TCMS is a reliable scale that assesses trunk control during functional activities, focusing on two components: static sitting balance and dynamic sitting balance. It consists of 15 items. Static sitting balance (items 1-5) evaluates trunk control while seated, while dynamic sitting balance includes selective movement control (items 6-12) for trunk movements in different planes, and dynamic reaching (items 13-15) for balance during reaching.The maximum scores are 20 for static sitting balance, 28 for selective movement control, and 10 for dynamic reaching. Higher scores indicate better trunk control performance.

    At baseline

  • Thoracic Kyphosis

    Thoracic kyphosis in participants with cerebral palsy (CP) was assessed using a digital inclinometer. Participants sat comfortably on a Bobath bed with their hips and knees flexed at 90 degrees and feet on the floor. The T1 and T12 vertebrae were marked, and a dual digital inclinometer was attached to these points. The recorded value on the inclinometer's screen was noted in degrees.

    At baseline

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with spastic cerebral palsy from city hospital and special education and rehabilitation center in Kocaeli and Sakarya, Turkey will be recruited for this study.

You may qualify if:

  • Received a diagnosis from a specialist doctor in the field
  • Willing to participate, along with their family
  • To be between the ages of 8-18
  • The child with CP is able to tolerate the required test positions for the study

You may not qualify if:

  • Received an additional diagnosis (down syndrome, autism, torticollis, etc.) other than CP from a specialist doctor in the field
  • Has cognitive problems or attention disorders that prevent him/her from fulfilling the assessment instructions
  • Botulinum Toxin A injection to the trunk or extremities, orthopedic surgery, and/or neurosurgery applications have been performed in the last six months.
  • Having uncorrected visual and/or hearing problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43020, Turkey (Türkiye)

Location

Related Publications (5)

  • Brun C, Traverse E, Granger E, Mercier C. Somatosensory deficits and neural correlates in cerebral palsy: a scoping review. Dev Med Child Neurol. 2021 Dec;63(12):1382-1393. doi: 10.1111/dmcn.14963. Epub 2021 Jun 17.

    PMID: 34145582BACKGROUND
  • Auld ML, Boyd RN, Moseley GL, Ware RS, Johnston LM. Impact of tactile dysfunction on upper-limb motor performance in children with unilateral cerebral palsy. Arch Phys Med Rehabil. 2012 Apr;93(4):696-702. doi: 10.1016/j.apmr.2011.10.025. Epub 2012 Feb 22.

    PMID: 22360974BACKGROUND
  • McLean B, Taylor S, Valentine J, Carey L, Thornton A, Elliott C. Somatosensory discrimination impairment in children with hemiplegic cerebral palsy as measured by the sense_assess(c) kids. Aust Occup Ther J. 2021 Aug;68(4):317-326. doi: 10.1111/1440-1630.12729. Epub 2021 Mar 18.

    PMID: 33738799BACKGROUND
  • Santana CAS, Dos Santos MM, de Campos AC. Interrelationships of Touch and Proprioception with Motor Impairments in Individuals with Cerebral Palsy: A Systematic Review. Percept Mot Skills. 2022 Jun;129(3):570-590. doi: 10.1177/00315125221093904. Epub 2022 Apr 22.

    PMID: 35452588BACKGROUND
  • Monica S, Nayak A, Joshua AM, Mithra P, Amaravadi SK, Misri Z, Unnikrishnan B. Relationship between Trunk Position Sense and Trunk Control in Children with Spastic Cerebral Palsy: A Cross-Sectional Study. Rehabil Res Pract. 2021 Aug 19;2021:9758640. doi: 10.1155/2021/9758640. eCollection 2021.

    PMID: 34462670BACKGROUND

MeSH Terms

Conditions

Cerebral PalsySpinal Curvatures

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Gulce KALLEM SEYYAR, PT, PhD

    Kutahya Health Sciences University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 15, 2024

First Posted

November 20, 2024

Study Start

April 22, 2024

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations