NCT05392322

Brief Summary

Down's syndrome is genetic disorder caused by trisomy 21. Children with Down's syndrome are characterized by awkward movements, gait, increased flexibility of joints, timing of mastering of basic skills, under development of fine motor skills. Virtual Reality Therapy (VRT) is a technique that uses interactive games as a physical therapy resource and has shown positive results in cortical reorganization, improving functional mobility, and quality of movement. This is an experimental study in which randomized controlled trials study design is being used.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

May 23, 2022

Last Update Submit

September 5, 2022

Conditions

Keywords

Fine motor skillsDown's SyndromeSelf- help skillsComputer game

Outcome Measures

Primary Outcomes (1)

  • The abilhand-kids tool

    The ABILHAND-KIDS tool was developed as a measure of manual ability of children with cerebral palsy. It describes most representative inventory of manual activities. The 21 items of ABILHAND-KIDS defined a valid and reliable manual ability scale. The ABILHAND-KIDS was originally developed by using the Rasch measurement model. It allows to convert ordinal score into linear measure located on unidimensional score.

    4th day

Study Arms (2)

Self-help skills

ACTIVE COMPARATOR

Effect of self-help skills on fine motor skills in children with down's syndrome

Other: Self-help skills

Virtual video reality gaming

EXPERIMENTAL

Effects of virtual video reality gaming on fine motor skills in children with down's syndrome

Device: Virtual video reality gaming

Interventions

Self-help skills were given to down's syndrome children 3 times per week upto 15 minutes.

Self-help skills

Virtual video reality gaming was given to children with down's Syndrome 3 time per week upto 15 minutes.

Virtual video reality gaming

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age group of patients ranged between 6 years to 10years.
  • Both the gender will be considered.
  • Subject who is able to follow the instruct

You may not qualify if:

  • Patients with medical co-morbid.
  • Gross deformity of upper /lower limb
  • Epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rising sun school for special children

Lahore, Punjab Province, 54792, Pakistan

RECRUITING

Related Publications (6)

  • Boato E, Melo G, Filho M, Moresi E, Lourenco C, Tristao R. The Use of Virtual and Computational Technologies in the Psychomotor and Cognitive Development of Children with Down Syndrome: A Systematic Literature Review. Int J Environ Res Public Health. 2022 Mar 3;19(5):2955. doi: 10.3390/ijerph19052955.

    PMID: 35270648BACKGROUND
  • Hocking DR, Ardalan A, Abu-Rayya HM, Farhat H, Andoni A, Lenroot R, Kachnowski S. Feasibility of a virtual reality-based exercise intervention and low-cost motion tracking method for estimation of motor proficiency in youth with autism spectrum disorder. J Neuroeng Rehabil. 2022 Jan 7;19(1):1. doi: 10.1186/s12984-021-00978-1.

    PMID: 34996473BACKGROUND
  • Klotzbier TJ, Holfelder B, Schott N. Associations of Motor Performance and Executive Functions: Comparing Children with Down Syndrome to Chronological and Mental Age-Matched Controls. Children (Basel). 2022 Jan 5;9(1):73. doi: 10.3390/children9010073.

    PMID: 35053698BACKGROUND
  • Jain PD, Nayak A, Karnad SD, Doctor KN. Gross motor dysfunction and balance impairments in children and adolescents with Down syndrome: a systematic review. Clin Exp Pediatr. 2022 Mar;65(3):142-149. doi: 10.3345/cep.2021.00479. Epub 2021 Jun 11.

    PMID: 34126707BACKGROUND
  • Beqaj S, Tershnjaku EET, Qorolli M, Zivkovic V. Contribution of Physical and Motor Characteristics to Functional Performance in Children and Adolescents with Down Syndrome: A Preliminary Study. Med Sci Monit Basic Res. 2018 Oct 16;24:159-167. doi: 10.12659/MSMBR.910448.

    PMID: 30323163BACKGROUND
  • Silva V, Campos C, Sa A, Cavadas M, Pinto J, Simoes P, Machado S, Murillo-Rodriguez E, Barbosa-Rocha N. Wii-based exercise program to improve physical fitness, motor proficiency and functional mobility in adults with Down syndrome. J Intellect Disabil Res. 2017 Aug;61(8):755-765. doi: 10.1111/jir.12384. Epub 2017 Jun 6.

    PMID: 28585394BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Hafiza Mehjabeen, MSPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiza Shahzadi, MSPPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

October 25, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations