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CompletedNCT06484465Updated Aug 2, 2024

Urdu Translation of Bimanaual Fine Motor Functional Classification System 2

An observational study in Cerebral Palsy, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 8 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-02.

Sponsored by Riphah International University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
50
Ages
8 Years to 15 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Cerebral Palsy

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Keywords

  • Bimanual fine motor classification-2
  • Cerebral Palsy
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's enrollment of 50 is below the median of 63 across 455 observational studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

    • Orthopedic conditions such as fractures or rickets
  • Systemic disorders, including inflammatory diseases and autoimmune conditions
  • Psychological and behavioral issues.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
50 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

1 site
  • Riphah International University
    Lahore, Punjab 54000, Pakistan
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06484465
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jul 3, 2024
Start date
Jun 27, 2024
Primary completion
Jul 15, 2024
Completion
Jul 20, 2024
Last update
Aug 2, 2024

Study contacts

Samar Mughal, MS*
principal investigator · Riphah International University
Tehreem Mukhtar, PhD *
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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