Cerebral PalsyNCT04768049
Urdu Version of Pediatric Balance Scale
An observational study of Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Tool Translation
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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)
Who cannot join
- • Suffering from any other condition that interfered with physical activity.
- Quadriplegic Flaccid CP, Choreo atheotoid CP
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan General Railway Hospital
Rawalpindi, Punjab Province, 46000
About this study
Official title: Cross-cultural Translation and Validity of the Pediatric Balance Scale (PBS) Into Urdu.
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.
Read the detailed description
Cross cultural researches are scientific methods which focus on making systematic comparisons from culture to culture responding to questions about the reasons of occurrence, dissemination and sources of variety in different cultures about compound issues referring to a similar problem across the globe arising from a wide spread field e.g. language which is an integral part of culture . 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.
Cerebral palsy is the most commonly affecting physical dysfunction of childhood. In United States alone 9200 - 9500 children including both infants and preschools are labelled with Cerebral palsy on yearly basis. It has a variety of appearances from isolated to global mental and mental impairments causing disturbance in a multiplicity of motor and cognitive functions such as gait disturbance and cognitive issues.
There are a lot of tools available which are used in physical therapy to assess balance in adults as well as children living with cerebral palsy and out of these tools one commonly used tool for pediatric population is Pediatric Balance Scale (PBS). According to the ICF domain it lies in the "Activity" category. The primary purpose of this scale is to evaluate and discriminate the capacity to maintain and achieve balance both in sitting and standing positions. It is a 14- item questionnaire, takes less than 15 minutes to administer and is used for cerebral palsy population aged between 5-15 years. In clinical settings standardized tools are thought useful in attaining scholarly objectives. But these standardized tools don't seem to serve their purpose to the fullest specifically in situations when they become indifferent to the culture and language of the population they are addressed to. This ultimately makes the assessment of persons from a varied culture groups difficult and hence makes the need of translations significant.
According to the reviewed literature Pediatric Balance Scale has already been translated into many other languages like Brazilian, Persian and Turkish. Validity and reliability of the tool has also been established in the fore mentioned languages. Despite being the need, till date Pediatric Balance Scale has not been translated into Urdu language. This study targets at the cross cultural adaptation of the tool's contents and the evaluation of the face validity, content validity, discriminate validity, construct validity, internal consistency and reliability of the translated version of pediatric balance scale will also be done for children diagnosed with Cerebral Palsy falling in the inclusion criteria.
In 2012 Lilian G K Ries conducted a research along with the research mates at University of Estado de Santa Catarina, Brazil under the title of "Cultural-adaptation and Reliability analysis of Brazilian version of pediatric balance scale (PBS)" and the results of this study concluded that PBS is adequately reliable for children diagnosed with Cerebral Palsy and having GMFCS level I and II. In 2019, Elnaz ALIMIl et al conducted a study with the aim to evaluate the Test-retest and inter-rater reliability of Persian version of Pediatric Balance Scale in children with spastic Cerebral Palsy. They concluded the study with the notion that the PBS shows high inter-rater reliability \& the test-retest reliability appropriate for measuring functional balance in children with spastic cerebral palsy with mild to moderate motor impairment. Arzu Erden conducted a study in 2020 to evaluate the Reliability and validity of Turkish version of PBS and showed that the Turkish version of the scale is a valid and reliable tool to evaluate children with balance impairments.
Another study conducted by Gi-won kim et al in 2010 evaluated reliability of PBS based on raters clinical experience and test experience showed high inter rater and intra rater reliability. In 2012 Jin Gang Her's study on Reliability of Pediatric Balance Scale in assessment of the children with cerebral palsy showed high inter rater and intra rater reliability of Pediatric Balance Scale in Children with Cerebral Palsy.In 2017 Sivatejaa Panibatla's study on Relationship of trunk control and balance in children with cerebral palsy suggested a strong correlation between trunk control and balance when evaluated using PBS.
In 2013 Mary rose et al showed in her study about the pediatric balance scale: a modified version of the berg scale for children with mild to moderate motor impairment that PBS demonstrate good test-retest and interrater reliability when used with school-age children with mild to moderate motor impairments.In 2000 Palisano et al conducted a study on validation of a model of GMFC in children with CP suggests that distinction between GMFC levels are meaningful. In 2013 Beatriz O et al suggested about Portuguese version of pediatric berg balance scale that this is a reliable tool to be used in balance assessment of Portuguese Children. A study conducted by Sue-mae gan et al in 2008 on psychometric properties of functional balance assessment in children with cerebral palsy and concluded that the 3 functional balance measures are simple, valid, and reliable for examining children with cerebral palsy and are thus suitable for clinical practice
- Conditions
- Cerebral Palsy
- Being tested
- Tool Translation
- Keywords
- Pediatric Balance scale, Cerebral palsy, Urdu version
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tool TranslationOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Jan 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misbah Ghous, MSNMPT, Principal investigator, Riphah International University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768049
- Sponsor's protocol ID
- REC/00746 Saima Mahmood
- Status last verified
- Jun 2021
- First submitted
- 18 Feb 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23679987Mason 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.
PubMed 15969225Ries 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.
PubMed 22699691Erden 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.
PubMed 32077065ALIMIl 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.
PubMed 31645876Kim 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).
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Translation and Validity of the Pediatric Balance Scale (PBS) Into Urdu.
- ClinicalTrials.gov ID
- NCT04768049
- Acronym / sponsor ID
- REC/00746 Saima Mahmood
- Conditions
- Cerebral Palsy
- Keywords
- Pediatric Balance scale, Cerebral palsy, Urdu version
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cross cultural researches are scientific methods which focus on making systematic comparisons from culture to culture responding to questions about the reasons of occurrence, dissemination and sources of variety in different cultures about compound issues referring to a similar problem across the globe arising from a wide spread field e.g. language which is an integral part of culture . 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.
Cerebral palsy is the most commonly affecting physical dysfunction of childhood. In United States alone 9200 - 9500 children including both infants and preschools are labelled with Cerebral palsy on yearly basis. It has a variety of appearances from isolated to global mental and mental impairments causing disturbance in a multiplicity of motor and cognitive functions such as gait disturbance and cognitive issues.
There are a lot of tools available which are used in physical therapy to assess balance in adults as well as children living with cerebral palsy and out of these tools one commonly used tool for pediatric population is Pediatric Balance Scale (PBS). According to the ICF domain it lies in the "Activity" category. The primary purpose of this scale is to evaluate and discriminate the capacity to maintain and achieve balance both in sitting and standing positions. It is a 14- item questionnaire, takes less than 15 minutes to administer and is used for cerebral palsy population aged between 5-15 years. In clinical settings standardized tools are thought useful in attaining scholarly objectives. But these standardized tools don't seem to serve their purpose to the fullest specifically in situations when they become indifferent to the culture and language of the population they are addressed to. This ultimately makes the assessment of persons from a varied culture groups difficult and hence makes the need of translations significant.
According to the reviewed literature Pediatric Balance Scale has already been translated into many other languages like Brazilian, Persian and Turkish. Validity and reliability of the tool has also been established in the fore mentioned languages. Despite being the need, till date Pediatric Balance Scale has not been translated into Urdu language. This study targets at the cross cultural adaptation of the tool's contents and the evaluation of the face validity, content validity, discriminate validity, construct validity, internal consistency and reliability of the translated version of pediatric balance scale will also be done for children diagnosed with Cerebral Palsy falling in the inclusion criteria.
In 2012 Lilian G K Ries conducted a research along with the research mates at University of Estado de Santa Catarina, Brazil under the title of "Cultural-adaptation and Reliability analysis of Brazilian version of pediatric balance scale (PBS)" and the results of this study concluded that PBS is adequately reliable for children diagnosed with Cerebral Palsy and having GMFCS level I and II. In 2019, Elnaz ALIMIl et al conducted a study with the aim to evaluate the Test-retest and inter-rater reliability of Persian version of Pediatric Balance Scale in children with spastic Cerebral Palsy. They concluded the study with the notion that the PBS shows high inter-rater reliability \& the test-retest reliability appropriate for measuring functional balance in children with spastic cerebral palsy with mild to moderate motor impairment. Arzu Erden conducted a study in 2020 to evaluate the Reliability and validity of Turkish version of PBS and showed that the Turkish version of the scale is a valid and reliable tool to evaluate children with balance impairments.
Another study conducted by Gi-won kim et al in 2010 evaluated reliability of PBS based on raters clinical experience and test experience showed high inter rater and intra rater reliability. In 2012 Jin Gang Her's study on Reliability of Pediatric Balance Scale in assessment of the children with cerebral palsy showed high inter rater and intra rater reliability of Pediatric Balance Scale in Children with Cerebral Palsy.In 2017 Sivatejaa Panibatla's study on Relationship of trunk control and balance in children with cerebral palsy suggested a strong correlation between trunk control and balance when evaluated using PBS.
In 2013 Mary rose et al showed in her study about the pediatric balance scale: a modified version of the berg scale for children with mild to moderate motor impairment that PBS demonstrate good test-retest and interrater reliability when used with school-age children with mild to moderate motor impairments.In 2000 Palisano et al conducted a study on validation of a model of GMFC in children with CP suggests that distinction between GMFC levels are meaningful. In 2013 Beatriz O et al suggested about Portuguese version of pediatric berg balance scale that this is a reliable tool to be used in balance assessment of Portuguese Children. A study conducted by Sue-mae gan et al in 2008 on psychometric properties of functional balance assessment in children with cerebral palsy and concluded that the 3 functional balance measures are simple, valid, and reliable for examining children with cerebral palsy and are thus suitable for clinical practice
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- • Suffering from any other condition that interfered with physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tool TranslationData 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 | Other | – |
Primary outcome
Pediatric balance scale
Time frame: up to 24 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Background: PubMed 23679987Saether 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.
- Background: PubMed 15969225Mason 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.
- Background: PubMed 22699691Ries 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.
- Background: PubMed 32077065Erden 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.
- Background: PubMed 31645876ALIMIl 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.
- BackgroundKim 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).
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Misbah Ghous, MSNMPT principal investigator
Riphah International University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric balance scale (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04768049, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.