Cerebral PalsyNCT06460779
Gross Motor Function and Living Skills in CP
An observational study of Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy (CP) is non-progressive disorder, which undergoes mishap to the developing brain and it affects a person's ability to move and maintain balance and posture. Old name of CP is "Little's disease".Through social and community participation, children and youth with cerebral palsy (CP) form friendships, gain… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 28 May 2024to 5 Aug 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: we measure age, gross motor function. ADLS in CP with the sample size of 100 students of schools under age 6-12 years
Who may be able to join
- Washington Group on Disability Statistics (WG) score greater than or equal to 12.
- Children with age group of 6 to 12 years.
- With diagnosis of CP.
- WHOdas Cognition - score 2.5.
- Mobility - score 2.5.
- Self-care - score 2.5 attending to one's hygiene, dressing, eating and staying alone.
Show all 9Show fewer
- Getting along -score 2.5 interacting with other people.
- Life activities -score 2.5 domestic responsibilities, leisure, work and school.
- Participation - score 2.5 joining in community activities, participating in society
Who cannot join
- Any unstable medical condition that precluded safe community physical activity.
- Having any orthopedic or neurological surgery in the previous 6 months.
- Moderate to profound Intellectual disability.
- Moderate to severe communication disability.
- Severe visual impairmen
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Association of Age, Gross Motor Function With Activities of Daily Living, Participation in Home and Community in Children With Cerebral Palsy
Cerebral palsy (CP) is non-progressive disorder, which undergoes mishap to the developing brain and it affects a person's ability to move and maintain balance and posture. Old name of CP is "Little's disease".Through social and community participation, children and youth with cerebral palsy (CP) form friendships, gain knowledge, learn skills, express creativity, and determine meaning and purpose in life. The purpose of this study is (1) to determine whether social and community participation of children and youth with CP differ based on age, sex, and gross motor function, and (2) to identify the types of activities in which social and community participation are highest
Read the detailed description
Those participants will be excluded having any unstable medical condition that precluded safe community physical activity, any orthopedic or neurological surgery in the previous 6 months, moderate to profound intellectual disability, moderate to severe communication disability, severe visual impairment, any sensory impairment or psychological disorder. The tools that will be used are WHODAS 2.0(WHO Disability Assessment Schedule), Washington Group Short Set of Disability Questions, Child and Adolescent Scale of Participation Activities of Daily Living, Functional Mobility and Participation. Data will be analyzed on SPSS version 25, normality of the data will be checked and data will be presented in the form of descriptive statistics, mean, SD range correlation.
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, childhood disablity, gross and motor function, participation, quality of life
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Washington Group Short Set of Disability Questions
The WG-SS is intended for use in censuses and surveys To maximize international comparability, the WG-SS obtains information on difficulties a person may have in undertaking basic functioning activities that apply to people in all cultures and societies and of all nationalities and so are universally applicable.
Measured: 6 weeks
Child and Adolescent Scale of Participation
The CASP is a 20-items 4-scales parent-report instrument covering attendance and involvement in the areas "home", "community", "school", and "living activities".
Measured: 6 weeks
Communication Function Classification System
The CFCS is a tool used to classify the everyday communication of an individual with cerebral palsy into one of five levels according to effectiveness of communication. It consists of five levels which describe everyday communication ability
Measured: 6 weeks
Secondary outcomes (1)
WHODAS 2.0 participation in home and community in children with cerebral palsy
practical, generic assessment instrument that can measure health and disability at population level. It captures the level of functioning in 6 domains of life
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start28 May 2024
- Primary completion1 Aug 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- saman ali, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460779
- Sponsor's protocol ID
- REC/RCR&AHS/23/0792
- Status last verified
- Oct 2024
- First submitted
- 11 Jun 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colver A, McConachie H, Le Couteur A, Dovey-Pearce G, Mann KD, McDonagh JE, Pearce MS, Vale L, Merrick H, Parr JR; Transition Collaborative Group. A longitudinal, observational study of the features of transitional healthcare associated with better outcomes for young people with long-term conditions. BMC Med. 2018 Jul 23;16(1):111. doi: 10.1186/s12916-018-1102-y.
PubMed 30032726Liao YT, Hwang AW, Liao HF, Granlund M, Kang LJ. Understanding the Participation in Home, School, and Community Activities Reported by Children with Disabilities and Their Parents: A Pilot Study. Int J Environ Res Public Health. 2019 Jun 24;16(12):2217. doi: 10.3390/ijerph16122217.
PubMed 31238490
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Age, Gross Motor Function With Activities of Daily Living, Participation in Home and Community in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06460779
- Acronym / sponsor ID
- REC/RCR&AHS/23/0792
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, childhood disablity, gross and motor function, participation, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 14 Jun 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.
Cerebral palsy (CP) is non-progressive disorder, which undergoes mishap to the developing brain and it affects a person's ability to move and maintain balance and posture. Old name of CP is "Little's disease".Through social and community participation, children and youth with cerebral palsy (CP) form friendships, gain knowledge, learn skills, express creativity, and determine meaning and purpose in life. The purpose of this study is (1) to determine whether social and community participation of children and youth with CP differ based on age, sex, and gross motor function, and (2) to identify the types of activities in which social and community participation are highest
Detailed description
Those participants will be excluded having any unstable medical condition that precluded safe community physical activity, any orthopedic or neurological surgery in the previous 6 months, moderate to profound intellectual disability, moderate to severe communication disability, severe visual impairment, any sensory impairment or psychological disorder. The tools that will be used are WHODAS 2.0(WHO Disability Assessment Schedule), Washington Group Short Set of Disability Questions, Child and Adolescent Scale of Participation Activities of Daily Living, Functional Mobility and Participation. Data will be analyzed on SPSS version 25, normality of the data will be checked and data will be presented in the form of descriptive statistics, mean, SD range correlation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- we measure age, gross motor function. ADLS in CP with the sample size of 100 students of schools under age 6-12 years
Key inclusion criteria (9 listed)
- Washington Group on Disability Statistics (WG) score greater than or equal to 12.
- Children with age group of 6 to 12 years.
- With diagnosis of CP.
- WHOdas Cognition - score 2.5.
- Mobility - score 2.5.
Key exclusion criteria (5 listed)
- Any unstable medical condition that precluded safe community physical activity.
- Having any orthopedic or neurological surgery in the previous 6 months.
- Moderate to profound Intellectual disability.
- Moderate to severe communication disability.
- Severe visual impairmen
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
Washington Group Short Set of Disability Questions
Time frame: 6 weeks
The WG-SS is intended for use in censuses and surveys To maximize international comparability, the WG-SS obtains information on difficulties a person may have in undertaking basic functioning activities that apply to people in all cultures and societies and of all nationalities and so are universally applicable.
Child and Adolescent Scale of Participation
Time frame: 6 weeks
The CASP is a 20-items 4-scales parent-report instrument covering attendance and involvement in the areas "home", "community", "school", and "living activities".
Communication Function Classification System
Time frame: 6 weeks
The CFCS is a tool used to classify the everyday communication of an individual with cerebral palsy into one of five levels according to effectiveness of communication. It consists of five levels which describe everyday communication ability
1 secondary outcome
WHODAS 2.0 participation in home and community in children with cerebral palsy
Time frame: 6 weeks
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 28 Oct 2024.
- Background: PubMed 30032726Colver A, McConachie H, Le Couteur A, Dovey-Pearce G, Mann KD, McDonagh JE, Pearce MS, Vale L, Merrick H, Parr JR; Transition Collaborative Group. A longitudinal, observational study of the features of transitional healthcare associated with better outcomes for young people with long-term conditions. BMC Med. 2018 Jul 23;16(1):111. doi: 10.1186/s12916-018-1102-y.
- Background: PubMed 31238490Liao YT, Hwang AW, Liao HF, Granlund M, Kang LJ. Understanding the Participation in Home, School, and Community Activities Reported by Children with Disabilities and Their Parents: A Pilot Study. Int J Environ Res Public Health. 2019 Jun 24;16(12):2217. doi: 10.3390/ijerph16122217.
- 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.
saman ali, MS 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 9 inclusion and 5 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 28 Oct 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?
Washington Group Short Set of Disability Questions (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 NCT06460779, which also lists 2 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 28 Oct 2024.