Clinical trial NCT06484465: Urdu Translation of Bimanaual Fine Motor Functional Classification System 2
Official title: Urdu Translation and Psychometric Analysis of Bimanual Functional Classification System BFMF2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Bimanual fine motor classification-2
Cerebral Palsy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

Brief 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

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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Bimanual fine motor classification system 2
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Samar Mughal, MS*
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: Tehreem Mukhtar, PhD *
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.