- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06484465
Urdu Translation of Bimanaual Fine Motor Functional Classification System 2
July 31, 2024 updated by: Riphah International University
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
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Riphah International University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Samar Mughal, MS*, Riphah International University
- Principal Investigator: Tehreem Mukhtar, PhD *, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2024
Primary Completion (Actual)
July 15, 2024
Study Completion (Actual)
July 20, 2024
Study Registration Dates
First Submitted
June 11, 2024
First Submitted That Met QC Criteria
June 25, 2024
First Posted (Actual)
July 3, 2024
Study Record Updates
Last Update Posted (Actual)
August 2, 2024
Last Update Submitted That Met QC Criteria
July 31, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0780
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.