NCT04225546

Brief Summary

The aim of this study is to examine the relationship between trunk control and lower extremity selective motor control during the movement of sit to stand (STS) in children with cerebral palsy (CP).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 4, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 4, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

January 4, 2020

Last Update Submit

January 8, 2020

Conditions

Cerebral Palsy, SpasticCerebral Palsy, Spastic, Diplegic

Keywords

cerebral palsyselective controltrunksit to stand

Outcome Measures

Primary Outcomes (1)

  • Trunk Control Measurement Scale (TCMS)

    TCMS measures the state of balance on the support surface and the ability to actively move body parts during functional activities, which are the two components of trunk control. TCMS consists of 15 items in total that are scored on 2, 3 or 4 point ordinal scale and administered bilaterally in case of clinical relevance. The total TCMS score ranges from 0 to 58. A high score on this scale represents a better performance.

    Baseline

Secondary Outcomes (5)

  • Selective Control Assessment of the Lower Extremity

    Baseline

  • Weight Transfer Time (sec) parameter of sit to stand test of Neurocome Balance Master

    Baseline

  • Rising Index (%) parameter of sit to stand test of Neurocome Balance Master

    Baseline

  • Sway Velocity (deg/sec)

    Baseline

  • Sitting domain of Gross Motor Function Measurement-88 (GMFM-88)

    Baseline

Study Arms (2)

Patient group

Patients with hemiplegic and diplegic cerebral palsy between 4 - 10 years of age

Control group

Healthy volunteer typically developing peers

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

16 spastic hemiplegic cerebral palsy patients, 12 spastic diplegic cerebral palsy patients between 4 - 10 years of age, and 32 healthy volunteer peers

You may qualify if:

  • Confirmed diagnosis of spastic hemiplegic or diplegic cerebral palsy
  • Age between 4 - 10
  • Were having a level of 1 or 2 of GMFCS
  • Able to stand without any orthosis or special equipment
  • No orthopedic surgery or not having Botulinum Toxin-A injection in the last 6 months
  • Volunteer to study

You may not qualify if:

  • Having cognitive disorder
  • Uncontrolled epilepsy
  • Lower extremity contracture that may affect assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (2)

  • Fowler EG, Staudt LA, Greenberg MB, Oppenheim WL. Selective Control Assessment of the Lower Extremity (SCALE): development, validation, and interrater reliability of a clinical tool for patients with cerebral palsy. Dev Med Child Neurol. 2009 Aug;51(8):607-14. doi: 10.1111/j.1469-8749.2008.03186.x. Epub 2009 Feb 12.

    PMID: 19220390RESULT

  • Heyrman L, Molenaers G, Desloovere K, Verheyden G, De Cat J, Monbaliu E, Feys H. A clinical tool to measure trunk control in children with cerebral palsy: the Trunk Control Measurement Scale. Res Dev Disabil. 2011 Nov-Dec;32(6):2624-35. doi: 10.1016/j.ridd.2011.06.012. Epub 2011 Jul 14.

    PMID: 21757321RESULT

MeSH Terms

Conditions

Cerebral PalsyCerebral palsy, spastic, diplegic

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Evrim Karadag Saygi, Prof

    Marmara University

    STUDY CHAIR

Central Study Contacts

Esra Karadag Saygı, Prof

CONTACT

+902166570606162evrim.saygi@marmara.edu.tr

Esra Giray, MD

CONTACT

+905558134394girayesra@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2020

First Posted

January 13, 2020

Study Start

January 4, 2020

Primary Completion

March 4, 2020

Study Completion

March 15, 2020

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

The data that support the findings of this study are available on request from the principal investigator (DG). The data are not publicly available due to their containing information that could compromise the privacy of research participants.

Locations

TU(1)