NCT04173871

Effects of Systematic Proprioceptive-tactile Stimulation With Use of the Protac MyFit®

Status unknown NA Last updated 3 May 2021

What this trial tests

NA trial testing Protac Myfit® in Sensory Processing Disorder in 240 participants. Status unknown.

Timeline

1 April 2020

Primary endpoint
1 July 2021

1 October 2021

Quick facts

Lead sponsor	University of Southern Denmark
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	240
Start date	1 April 2020
Primary completion	1 July 2021
Estimated completion	1 October 2021
Sites	1 location across Denmark

Drugs / interventions tested

• Protac Myfit®

Conditions studied

• Sensory Processing Disorder — all drugs for Sensory Processing Disorder →
• Children — all drugs for Children →

Sponsor

University of Southern Denmark

Who can join

Adults 6 to 12, any sex, with Sensory Processing Disorder or Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Children with sensory impairment (SPD) are often unable to sit still and focus their attention. This can affect the children by limiting their opportunities for participation in school activities. Previous studies indicate a link between childhood SPD, childhood anxiety, and obsessive-compulsive disorder (OCD) in adulthood. Research and clinical experience suggest that systematic use of proprioceptive-tactile stimulant aids may have a positive effect for children with SPD.

The aim of the project is to investigate and describe the effects of a systematic use of proprioceptive-tactile stimulating vest, MyFit®, for children 6-12 years with SPD in the form of sensory-seeking behaviour.

Research questions:

* Can systematic use of MyFit® for children with sensory seeking behaviour increase their participation in school activities?
* Can systematic use of MyFit® support children with sensory seeking behaviour to increase their awareness, concentration and focus on tasks?
* Can systematic use of MyFit® affect children's feelings of confidence and self-efficacy? The project seeks to answer these questions to contribute to knowledge on how children with sensory seeking behaviours can be supported for better participation in school activities.

The study will be a randomized controlled trial of 240 children with SPD and sensory seeking behaviour.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Perspective on Newly Emerging Proteolysis-Targeting Strategies in Antimicrobial Drug Discovery.
   Venkatesan J, Murugan D, Rangasamy L. · · 2022 · cited 10× · PMID 36551374 · DOI 10.3390/antibiotics11121717
2. Teachers' and Parents' Assessment of Challenges in Children Exhibiting Sensory Seeking Behavior and Possible Effects of the Use of Ball Vests: A Pre-Post Study.
   Nielsen AN, la Cour K, Brandt Å. · · 2023 · cited 1× · PMID 38002891 · DOI 10.3390/children10111800