Cerebral PalsyNCT06484465
Urdu Translation of Bimanaual Fine Motor Functional Classification System 2
An observational study of Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
In 2002, Beckung and Hagberg introduced the Bimanual Fine Motor Function (BFMF) classification system. However, the initial version struggled to clearly distinguish between its five defined levels. Despite this, the BFMF system aimed to align with the Gross Motor Function Classification System (GMFCS) levels. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Jun 2024to 20 Jul 2024
- 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: the study focuses on school-aged children with various types of Cerebral Palsy, with moderate to severe gross motor impairments, as classified by the GMFCS system. The study does not include children who have musculoskeletal problems, chronic health conditions, or mental health concerns that may impact their ability to participate or affect the study's outcomes.
Who may be able to join
- Age: 8-15 years
- Gender: Both male and female patients
- Type of CP: Diplegic, athetoid, ataxic, and spastic forms
- Gross Motor Function Classification System (GMFCS) level: 2 or 3
Who cannot join
- - Orthopedic conditions such as fractures or rickets
- Systemic disorders, including inflammatory diseases and autoimmune conditions
- Psychological and behavioral issues.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Urdu Translation and Psychometric Analysis of Bimanual Functional Classification System BFMF2
In 2002, Beckung and Hagberg introduced the Bimanual Fine Motor Function (BFMF) classification system. However, the initial version struggled to clearly distinguish between its five defined levels. Despite this, the BFMF system aimed to align with the Gross Motor Function Classification System (GMFCS) levels. Since its introduction, the BFMF system has been widely utilized in the Surveillance of Cerebral Palsy in Europe (SCPE) registry and various epidemiological studies
Read the detailed description
Beckung and Hagberg developed the Bimanual Fine Motor Function (BFMF) classification system in 2002. Although the initial version had limitations in clearly differentiating between its five levels, it aimed to align with the Gross Motor Function Classification System (GMFCS). Since then, the BFMF system has been widely used in the Surveillance of Cerebral Palsy in Europe (SCPE) registry and various epidemiological studies. The BFMF is a five-level ordinal scale, ranging from Level I (best performance) to Level V (most limited function), designed to assess the ability of children with cerebral palsy to use both hands together to handle objects. Evaluation is based on observation of bimanual performance and parental reports of usual performance. This study consists of two parts: a pilot study for physiotherapists, with defined inclusion and exclusion criteria, and a main study involving cerebral palsy patients, using a finalized Urdu version of the questionnaire to collect data.
- Conditions
- Cerebral Palsy
- Keywords
- Bimanual fine motor classification-2, Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Bimanual fine motor classification system 2
Urdu version of Bimanual fine motor classification system 2 The Bimanual Fine Motor Function (BFMF) classifies fine motor function in children with cerebral palsy. The five levels in BFMF form an ordinal scale, which means that the levels are 'ordered' but differences between levels are not necessarily equal, and each level includes children with relatively varied function. It is therefore unlikely that BFMF is sensitive to changes after an intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start27 Jun 2024
- Primary completion15 Jul 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samar Mughal, MS*, Principal investigator, Riphah International UniversityTehreem Mukhtar, PhD *, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484465
- Sponsor's protocol ID
- REC/RCR & AHS/23/0780
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seyhan-Biyik K, Delioglu K, Tuncdemir M, Unes S, Ozal C, Kerem-Gunel M. Asymmetric involvement of hands: Psychometric properties of the Turkish version of the Bimanual Fine Motor Function 2.0 classification in children with cerebral palsy. J Hand Ther. 2024 Jul-Sep;37(3):429-437. doi: 10.1016/j.jht.2023.08.006. Epub 2023 Sep 28.
PubMed 37777439
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urdu Translation and Psychometric Analysis of Bimanual Functional Classification System BFMF2
- ClinicalTrials.gov ID
- NCT06484465
- Acronym / sponsor ID
- REC/RCR & AHS/23/0780
- Conditions
- Cerebral Palsy
- Keywords
- Bimanual fine motor classification-2, Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 3 Jul 2024 (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.
In 2002, Beckung and Hagberg introduced the Bimanual Fine Motor Function (BFMF) classification system. However, the initial version struggled to clearly distinguish between its five defined levels. Despite this, the BFMF system aimed to align with the Gross Motor Function Classification System (GMFCS) levels. Since its introduction, the BFMF system has been widely utilized in the Surveillance of Cerebral Palsy in Europe (SCPE) registry and various epidemiological studies
Detailed description
Beckung and Hagberg developed the Bimanual Fine Motor Function (BFMF) classification system in 2002. Although the initial version had limitations in clearly differentiating between its five levels, it aimed to align with the Gross Motor Function Classification System (GMFCS). Since then, the BFMF system has been widely used in the Surveillance of Cerebral Palsy in Europe (SCPE) registry and various epidemiological studies. The BFMF is a five-level ordinal scale, ranging from Level I (best performance) to Level V (most limited function), designed to assess the ability of children with cerebral palsy to use both hands together to handle objects. Evaluation is based on observation of bimanual performance and parental reports of usual performance. This study consists of two parts: a pilot study for physiotherapists, with defined inclusion and exclusion criteria, and a main study involving cerebral palsy patients, using a finalized Urdu version of the questionnaire to collect data.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- the study focuses on school-aged children with various types of Cerebral Palsy, with moderate to severe gross motor impairments, as classified by the GMFCS system. The study does not include children who have musculoskeletal problems, chronic health conditions, or mental health concerns that may impact their ability to participate or affect the study's outcomes.
Key inclusion criteria (4 listed)
- Age: 8-15 years
- Gender: Both male and female patients
- Type of CP: Diplegic, athetoid, ataxic, and spastic forms
- Gross Motor Function Classification System (GMFCS) level: 2 or 3
Key exclusion criteria (3 listed)
- - Orthopedic conditions such as fractures or rickets
- Systemic disorders, including inflammatory diseases and autoimmune conditions
- Psychological and behavioral issues.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bimanual fine motor classification system 2
Time frame: 6 months
Urdu version of Bimanual fine motor classification system 2 The Bimanual Fine Motor Function (BFMF) classifies fine motor function in children with cerebral palsy. The five levels in BFMF form an ordinal scale, which means that the levels are 'ordered' but differences between levels are not necessarily equal, and each level includes children with relatively varied function. It is therefore unlikely that BFMF is sensitive to changes after an intervention.
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 2 Aug 2024.
- Background: PubMed 37777439Seyhan-Biyik K, Delioglu K, Tuncdemir M, Unes S, Ozal C, Kerem-Gunel M. Asymmetric involvement of hands: Psychometric properties of the Turkish version of the Bimanual Fine Motor Function 2.0 classification in children with cerebral palsy. J Hand Ther. 2024 Jul-Sep;37(3):429-437. doi: 10.1016/j.jht.2023.08.006. Epub 2023 Sep 28.
- 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.
Samar Mughal, MS* principal investigator
Riphah International University
Tehreem Mukhtar, PhD * principal investigator
Riphah International University
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 4 inclusion and 3 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 2 Aug 2024. 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?
Bimanual fine motor classification system 2 (time frame: 6 months). 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 NCT06484465, which also lists 1 linked publication.
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 2 Aug 2024.