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

NCT04173871 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2021-05-03

No results posted yet for this study

Summary

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.

Conditions

  • Sensory Processing Disorder
  • Children

Interventions

DEVICE

Protac Myfit®

A systematic proprioceptive-tactile stimulation by the Protac MyFit® vest. The children are asked to wear the Protac Myfit® vest from the beginning of every school day and for at least two sessions for three weeks.

Sponsors & Collaborators

  • Protac A/S

    collaborator UNKNOWN

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Ann Natasja Nielsen, PhD. Student · University of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2021-07-01
Completion
2021-10-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04173871 on ClinicalTrials.gov