NCT05475132

Brief Summary

Through this study we aim to determine the effect of Exergaming on bimanual hand dexterity in Autistic children. This randomized controlled trial will recruit a sample of 20 autistic children as per the inclusion and exclusion criteria, through convenient sampling. The sample will be then randomly allocated to control group receiving the conventional dexterity training exercises and Intervention group which will be receiving conventional plus exergaming intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

June 15, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

July 14, 2022

Last Update Submit

July 31, 2023

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum DisorderExergamingDexterity

Outcome Measures

Primary Outcomes (1)

  • Minnesota Manual Dexterity Test (MMDT)

    This test evaluates the gross motor skill of the assessed individual, including the the unilateral and bilateral manual dexterity. It is used for various purposes including the measurement of disability , specific training programs and manual activities in practical life, as to hand grip strength

    4 weeks

Secondary Outcomes (1)

  • Box and Block Tests (BBT)

    4 weeks

Study Arms (2)

Exergaming

EXPERIMENTAL

App based exercise games for dexterity will be used

Other: Exergaming

Conventional Dexterity Exercises

ACTIVE COMPARATOR

Dexterity exercises used conventionally will be done in this.

Other: Conventional Dexterity Exercises

Interventions

ExergamingOTHER

exercise games will be done for a total of 8 weeks ,100min of exergaming/week (5 days × 20 min).

Exergaming
Conventional Dexterity ExercisesOTHER

Exercises traditionally used for dexterity will be done for 8 weeks, 100min of exercises/week (5days × 20 min)

Conventional Dexterity Exercises

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male and female children pre-diagnosed with autism spectrum disorder.
  • Autistic Children who are compliant with exergaming

You may not qualify if:

  • Children not pre-diagnosed with autism spectrum disorder
  • Autistic Children who have other coordination disorder such as developmental coordination disorder
  • Autistic Children with upper limb amputation.
  • Autistic children with loss of vision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CARD(Clinic for autism and related disorders)

Lahore, Punjab Province, 53700, Pakistan

Location

Lahore Autism Centre

Lahore, Punjab Province, 54792, Pakistan

Location

Related Publications (10)

  • Lord C, Brugha TS, Charman T, Cusack J, Dumas G, Frazier T, Jones EJH, Jones RM, Pickles A, State MW, Taylor JL, Veenstra-VanderWeele J. Autism spectrum disorder. Nat Rev Dis Primers. 2020 Jan 16;6(1):5. doi: 10.1038/s41572-019-0138-4.

    PMID: 31949163BACKGROUND

  • Kim SK. Recent update of autism spectrum disorders. Korean J Pediatr. 2015 Jan;58(1):8-14. doi: 10.3345/kjp.2015.58.1.8. Epub 2015 Jan 31.

    PMID: 25729393BACKGROUND

  • Paquet A, Olliac B, Golse B, Vaivre-Douret L. Nature of motor impairments in autism spectrum disorder: A comparison with developmental coordination disorder. J Clin Exp Neuropsychol. 2019 Feb;41(1):1-14. doi: 10.1080/13803395.2018.1483486. Epub 2018 Jun 20.

    PMID: 29923455BACKGROUND

  • Pixa NH, Steinberg F, Doppelmayr M. High-definition transcranial direct current stimulation to both primary motor cortices improves unimanual and bimanual dexterity. Neurosci Lett. 2017 Mar 16;643:84-88. doi: 10.1016/j.neulet.2017.02.033. Epub 2017 Feb 14.

    PMID: 28229937BACKGROUND

  • Fulceri F, Grossi E, Contaldo A, Narzisi A, Apicella F, Parrini I, Tancredi R, Calderoni S, Muratori F. Motor Skills as Moderators of Core Symptoms in Autism Spectrum Disorders: Preliminary Data From an Exploratory Analysis With Artificial Neural Networks. Front Psychol. 2019 Jan 9;9:2683. doi: 10.3389/fpsyg.2018.02683. eCollection 2018.

    PMID: 30687159BACKGROUND

  • Friel KM, Kuo HC, Fuller J, Ferre CL, Brandao M, Carmel JB, Bleyenheuft Y, Gowatsky JL, Stanford AD, Rowny SB, Luber B, Bassi B, Murphy DL, Lisanby SH, Gordon AM. Skilled Bimanual Training Drives Motor Cortex Plasticity in Children With Unilateral Cerebral Palsy. Neurorehabil Neural Repair. 2016 Oct;30(9):834-44. doi: 10.1177/1545968315625838. Epub 2016 Feb 11.

    PMID: 26867559BACKGROUND

  • Fang Q, Aiken CA, Fang C, Pan Z. Effects of Exergaming on Physical and Cognitive Functions in Individuals with Autism Spectrum Disorder: A Systematic Review. Games Health J. 2019 Apr;8(2):74-84. doi: 10.1089/g4h.2018.0032. Epub 2018 Oct 17.

    PMID: 30332294BACKGROUND

  • Rafiei Milajerdi H, Sheikh M, Najafabadi MG, Saghaei B, Naghdi N, Dewey D. The Effects of Physical Activity and Exergaming on Motor Skills and Executive Functions in Children with Autism Spectrum Disorder. Games Health J. 2021 Feb;10(1):33-42. doi: 10.1089/g4h.2019.0180. Epub 2020 Dec 23.

    PMID: 33370161BACKGROUND

  • van Beek JJW, van Wegen EEH, Bohlhalter S, Vanbellingen T. Exergaming-Based Dexterity Training in Persons With Parkinson Disease: A Pilot Feasibility Study. J Neurol Phys Ther. 2019 Jul;43(3):168-174. doi: 10.1097/NPT.0000000000000278.

    PMID: 31136450BACKGROUND

  • Gao Z, Zeng N, Pope ZC, Wang R, Yu F. Effects of exergaming on motor skill competence, perceived competence, and physical activity in preschool children. J Sport Health Sci. 2019 Mar;8(2):106-113. doi: 10.1016/j.jshs.2018.12.001. Epub 2018 Dec 6.

    PMID: 30997256BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sara Aabroo

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2022

First Posted

July 26, 2022

Study Start

June 15, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)