- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05978778
Effects of Active Video Gaming on Pre-handwriting Skills of Children With Down Syndrome.
Down's syndrome is a genetic disorder caused by trisomy 21. Down's syndrome is most common genetic mental disability that affects children physically, mentally and functionally. It occurs due to an extra copy of chromosome 21. It involves a slightly flattened facial profile, low muscle tone upward-slanted eyes, and ligamentous laxity. Central hypotonia, mental retardation and short stature are very common features of children with down's syndrome. Children with down's syndrome are characterized by awkward movements, gait, increased flexibility of joints, timing of mastering of basic skills and , under-development of fine motor skills. Active video gaming used different games that involve interactive session that can enhance cortical recognition, motor learning and functional profile of children with DS. The objective of this study is to determine the effects of active video gaming on pre-hand writing skills of children with down's syndrome. This will be a RCT(Randomized Controlled Trial).The sample size was 18 and the study design was a case-control trial. The inclusion criteria are children with down syndrome age 6 to 12 years both male and female patients are randomly selected and children with poor pre-hand writing skills. And the exclusion criteria for this study is children with any other neurological condition like (epilepsy, instability of atlantoaxial joints, cardiac anomalies,) vision, and hearing loss. Two groups were randomly assigned and equally divided patients into each group. Group A received pre-handwriting skills, like tracing alphabets and numbers, scribbling, coloring, painting, and group B received active video gaming and prehandwriting skills. For measuring each group developmental coordination
disorder questionnaire tool is used. The session will be taken 30 mins thrice a week for (8consecutive weeks). Data collected from different centers, Raising sun institute of special education. Autism resource center Lahore. SPSS for Windows software, version 25 will be used to analyze the data using statistical Significance p=0.05. The Shapiro-Wilk test will be used to check the normality of data. Keywords: Active video gaming, Down syndrome, Computer game, Fine motor skills, Pre-hand writing skills, Virtual reality gaming.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Lingua Speech Model town
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 5 to 14 years.
- Both male and female patient diagnosed with down syndrome.
- Able to understand and follow verbal command.
- Down syndrome children with pre-hand writing skills are not good.
- Difficulty in fine motor skills.
Exclusion Criteria:
- Patients will have any neurological sign (epilepsy, instability of the atlantoaxial joint, cardiac anomalies, vision and hearing loss, speech loss.
- Musculoskeletal and mobility disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: controlled group
Nine children will be randomly allocated to control group who receive only pre-hand writing skills.
|
pre-hand writing skills
|
|
Experimental: Experimental group
Nine children will be randomly allocated to experimental group who receive active video gaming along with pre-hand writing skills.
|
pre-hand writing skills
wii sports is a collection five sports game stimulation,which have been designed to demonstrate the motion sensing capabilities of wii remote
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pre handwriting skills syndrome.
Time Frame: 6 months
|
bilateral hand use will determine by box and ball test children with down syndrome.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nageen Zahra, ms, Ripha International Univerity
Publications and helpful links
General Publications
- O'BRIEN JC, O'BRIEN MO. Educational Systems. Pediatric Skills for Occupational Therapy Assistants E-Book. 2020 Jul 12:46.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0722
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Down Syndrome
-
Rachel G. Greenberg, MD, MB, MHSEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsTerminatedHyperactivity in Children With Down Syndrome | Impulsivity in Children With Down SyndromeUnited States
-
Izgi Miray DemirbagRecruitingDown Syndrome (DS)Turkey (Türkiye)
-
Brigham and Women's HospitalNational Institutes of Health (NIH)Not yet recruitingDown Syndrome (DS)United States
-
Universidad de BurgosEuropean University Miguel de CervantesRecruiting
-
Aelis FarmaHospital del Mar Research Institute (IMIM)Enrolling by invitation
-
Sohag UniversityActive, not recruitingDown Syndrome | Cervical Spine Instability in Down SyndromeEgypt
-
Riphah International UniversityCompletedDown S SyndromePakistan
-
Hoffmann-La RocheCompletedHealthy Volunteer, Down SyndromeUnited Kingdom
-
Cairo UniversityCompleted
-
Institute of Child HealthCompleted
Clinical Trials on pre-hand writing skills
-
Oxford Brookes UniversityNational Institute for Health Research, United Kingdom; Royal Berkshire NHS... and other collaboratorsCompleted
-
Eunice Kennedy Shriver National Institute of Child...CompletedDyslexia | Learning DisordersUnited States
-
Wayne State UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed
-
University of MichiganCompletedMental Disorders | Psychiatric Hospitalization | Child/Adolescent Problems
-
Raghda Gamal Ateya Abd-ElbaryEnrolling by invitationBilateral Cerebral PalsyEgypt
-
St. Jude Children's Research HospitalCompletedSickle Cell DiseaseUnited States
-
University of ArkansasActive, not recruitingStroke | Rehabilitation | Aphasia, Acquired | Language Disorder, AcquiredUnited States
-
Washington University School of MedicineCompleted
-
Fenway Community HealthNational Institute of Mental Health (NIMH)CompletedRisk ReductionUnited States
-
Assistance Publique - Hôpitaux de ParisCompletedMovement Disorders | Wilson Disease | Repetitive Transcranial Magnetic StimulationFrance