AzTrials
AzTrials

Autism Spectrum DisorderNCT05475132

Exergaming on Hand Dexterity In Autistic Children

A study testing Exergaming and Conventional Dexterity Exercises in people with Autism Spectrum Disorder, run by Riphah International University at 2 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 12 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Exergaming and Conventional Dexterity Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesPakistan
Study dates
15 Jun 2022to 28 Feb 2023
Phase
Interventional
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 5 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites

  • CARD(Clinic for autism and related disorders)

    Lahore, Punjab Province, 53700

  • Lahore Autism Centre

    Lahore, Punjab Province, 54792

Other trials in Pakistan

About this study

Official title: Effects of Exergaming on Bimanual Hand Dexterity in Autistic Children

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.

Read the detailed description

A study showed that a structured traditional physical activity intervention that targets specific MS resulted in motor function improvement in children with ASD along with exergaming that can improve EF in children with ASD.

On a population of 20 patients with CP, Structured Neurodevelopmental Therapy-based hand rehabilitation (SNDTBHR) was applied and in the results Positive effects of both interventions i.e. SNDTBHR and LMBET were found. Significant differences were found between LMBET and SNDTBHR on GGF, pinch forces, JHFT, and WCST all being in the favor of LMBET. Exergaming interventions in the individuals with ASD showed significant improvements in the physical fitness, executive functioning, and their self perception. Exergaming increased the interest and participation of Autistic children in moderate-to-vigorous physical activity. In contrast, exergaming had small impact on emotional regulation As per the results of another study participants with poorer dexterity in the beginning of exergaming training program greatly improved their dexterity performance, which also improved their quality of life. Adherence and motivation increased significantly and system usability of the exergaming was acceptable. Participants with impaired dexterity showed improvement in the Nine-Hole Peg Test and the PDQ-39

According the researchers knowledge there have been numerous studies conducted on the effect of different exercise protocols on autistic children but there is lack of evidence in determining the effect of exergaming on specifically hand functioning/ dexterity in autistic population'. More studies should be done in order to check if exergaming or conventional treatment differ in their effect on hand dexterity in autistic children. Home based exergaming and low cost video assisted games for dexterity need more in depth study so that they can be readily used by general public.

Being tested
Exergaming, Conventional Dexterity Exercises
Keywords
Autism Spectrum Disorder, Exergaming, Dexterity
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExergamingOther

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

  • Conventional Dexterity ExercisesOther

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

Study groups in NCT05475132
Study groupRoleWhat they receive
ExergamingExperimentalApp based exercise games for dexterity will be used
Receives: Other: Exergaming
Conventional Dexterity ExercisesActive comparatorDexterity exercises used conventionally will be done in this.
Receives: Other: Conventional Dexterity Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 weeks

Secondary outcomes (1)

  1. Box and Block Tests (BBT)

    It is designed to measure manual dexterity, which often underestimated in assessment of patients. The BBT consists of transporting small pieces of wood from one side to the other for one minute. These blocks must be taken from end to end from a wooden box with partition. The number of blocks has to be recorded for the upper dominant and non-dominant member upon three attempts for each member

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2022
  2. Study start15 Jun 2022
  3. Primary completion28 Feb 2023
  4. Study completion28 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05475132
Sponsor's protocol ID
REC/22/0204 Maham Shabbir
Status last verified
Jul 2023
First submitted
14 Jul 2022
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31949163

  • 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.

    PubMed 25729393

  • 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.

    PubMed 29923455

  • 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.

    PubMed 28229937

  • 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.

    PubMed 30687159

  • 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.

    PubMed 26867559

  • 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.

    PubMed 30332294

  • 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.

    PubMed 33370161

  • 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.

    PubMed 31136450

  • 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.

    PubMed 30997256

Questions about this trial

What is this clinical trial studying?

A study testing Exergaming and Conventional Dexterity Exercises in people with Autism Spectrum Disorder, run by Riphah International University at 2 sites 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 2 inclusion and 4 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Minnesota Manual Dexterity Test (MMDT) (time frame: 4 weeks). 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 NCT05475132, which also lists 10 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 1 Aug 2023.

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