NCT04768049

Brief Summary

Children with cerebral palsy often suffer from a lack of balance compared with typically developing children. Because balance capacity is relevant to functional activities, reliable and valid functional balance measures are crucial for the pediatric clinical setting in local native languages, so the aim of this study is to translate the Pediatric Balance Scale (PBS) into Urdu and to find the reliability and validity of the translated version Pediatric Balance Scale (PBS) in cerebral palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

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

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

February 18, 2021

Last Update Submit

June 26, 2021

Conditions

Keywords

Pediatric Balance scaleCerebral palsyUrdu version

Outcome Measures

Primary Outcomes (1)

  • Pediatric balance scale

    The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points

    up to 24 weeks

Interventions

Data Collection procedure will be done in two phases. The first phase will revolve around the translation of the instrument. Firstly the tool will be translated into Urdu with help of two professional translators and then it will be back translated into English to cross check the clarity of text. The translation will focus more on the context and understanding of the text rather literal word-to-word meanings. The translation will be done according to the WHO guidelines

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

• To translate the Pediatric Balance Scale (PBS) into Urdu, and to find the reliability and validity of the translated version Pediatric Balance Scale (PBS) in cerebral palsy

You may qualify if:

  • diagnosis of spastic hemi and diplegic CP
  • age between 5 and 15 years,
  • able to accept and follow verbal instructions,
  • ability to independently maintain a standing position for at least four seconds,
  • Gross Motor Function Classification System \[GMFCS\] levels I-II)

You may not qualify if:

  • Suffering from any other condition that interfered with physical activity.
  • Quadriplegic Flaccid CP, Choreo atheotoid CP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan General Railway Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (6)

  • Saether R, Helbostad JL, Riphagen II, Vik T. Clinical tools to assess balance in children and adults with cerebral palsy: a systematic review. Dev Med Child Neurol. 2013 Nov;55(11):988-99. doi: 10.1111/dmcn.12162. Epub 2013 May 16.

    PMID: 23679987BACKGROUND
  • Mason TC. Cross-cultural instrument translation: assessment, translation, and statistical applications. Am Ann Deaf. 2005 Spring;150(1):67-72. doi: 10.1353/aad.2005.0020.

    PMID: 15969225BACKGROUND
  • Ries LG, Michaelsen SM, Soares PS, Monteiro VC, Allegretti KM. Cross-cultural adaptation and reliability analysis of the Brazilian version of Pediatric Balance Scale (PBS). Rev Bras Fisioter. 2012 Jun;16(3):205-15. doi: 10.1590/s1413-35552012005000026. Epub 2012 Jun 14. English, Portuguese.

    PMID: 22699691BACKGROUND
  • Erden A, Acar Arslan E, Dundar B, Topbas M, Cavlak U. Reliability and validity of Turkish version of pediatric balance scale. Acta Neurol Belg. 2021 Jun;121(3):669-675. doi: 10.1007/s13760-020-01302-9. Epub 2020 Feb 19.

    PMID: 32077065BACKGROUND
  • ALIMIl E, Kalantari M, Nazeri AR, Akbarzade Baghban A. Test-retest & Inter-rater Reliability of Persian Version of Pediatric Balance Scale in Children with Spastic Cerebral Palsy. Iran J Child Neurol. 2019 Fall;13(4):163-171.

    PMID: 31645876BACKGROUND
  • Kim G-w. The Reliability of Pediatric Balance Scale on Rater's Clinical work expereience and Test experience The Journal Korean Society of Physical Therapy. 2010.Her J-G. Reliability of Pediatric Balance Scale in Assesment of the Children with Cerebral Palsy 2012;24(301-305).

    BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Misbah Ghous, MSNMPT

    Riphah International University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2021

First Posted

February 24, 2021

Study Start

January 1, 2021

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations