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Effect of Neuromodulation associated with Gametherapy on upper limb function and brain activity in children with Down Syndrome: double-blind, placebo-controlled, crossover clinical trial

Effect of Transcranial Direct Current Stimulation associated with Gametherapy on function, upper limbs reaching movement and brain activity in children with Down Syndrome: crossed, placebo-controlled and double blind clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7xhvw6n
Enrollment
Unknown
Registered
2022-11-08
Start date
2023-01-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome

Interventions

Individuals who meet the eligibility criteria, those responsible for accepting to participate in the study will be randomly allocated to one of the study groups, by a randomization method through the
stretching of biceps brachii, triceps brachii and brachioradialis performed in three series of thirty seconds each, free active exercises for strengthening with a ball where the child will pick up the
L01.224.160.875

Sponsors

Universidade Evangélica de Goiás
Lead Sponsor
Universidade Evangélica de Goiás
Collaborator

Eligibility

Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Diagnosis of Down Syndrome; adequate understanding and cooperation during proceedings;age between six and twelve years; impairment of upper limb motor coordination and declaration of free and informed consent signed by a legal guardian; neurotypical; adequate understanding and cooperation during proceedings; age between six and twelve years; declaration of free and informed consent signed by a legal guardian, consent form signed by the child.

Exclusion criteria

Exclusion criteria: Children who have undergone surgical procedures in the twelve months prior to the beginning of the training sessions; orthopedic deformity of the lower limbs or spine with surgical indication; uncontrolled epilepsy; metallic implant in the skull or hearing aids; associated neurological disorder; and pacemaker use; associated neurological disorders, bone deformity in the lower and upper limbs, uncorrected visual deficit.

Design outcomes

Primary

MeasureTime frame
It is expected to find a decrease in the total execution time of the movement generated by an increase in the average speed of the movement. The path of movement performed by the upper limbs should be more harmonic and more direct after the end of the interventions, which will be evaluated by the three-dimensional analysis of the movement of the upper limbs.

Secondary

MeasureTime frame
It is expected that after training there will be an increase in muscle torque evaluated by electromyography, harmonizing the execution of the movement of the elbow flexor and extensor muscles, in the active therapy group compared to the control, in the moments after intervention.;Assess brain electrical activity using electroencephalography. It is expected that after the intervention, a modulation of diffuse cortical activity will be observed, resulting in an improvement in the quality of upper limb movements.;The training proposed in the study is expected to improve the execution time of the movement of taking a block from one side to the other for one minute when applying the box and block scale. It is also expected to observe a greater muscular resistance in the accomplishment of the movement. As well as a more harmonic and efficient brain activity, in the post-intervention moments evaluated by electromyography and electroencephalogram.

Countries

Brazil

Contacts

Public ContactCláudia Oliveira

Universidade Evangélica de Goiás

claudia.oliveira@unievangelica.edu.br+55(62)3310-6600

Outcome results

None listed

Source: REBEC (via WHO ICTRP)