Effects of Systematic Proprioceptive-tactile Stimulation With Use of the Protac MyFit®
1 other identifier
interventional
240
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2019
CompletedFirst Posted
Study publicly available on registry
November 22, 2019
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedMay 3, 2021
April 1, 2021
1.2 years
October 31, 2019
April 30, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Test of Everyday Attention - Children (TEA-Ch)
TEA-Ch is a normed and standardised battery of 9 tests, that examines the child's ability for three different types of attention (selective attention, sustained attention and attentional control/switching)
21 days
Child Occupational Self Assessment (COSA)
COSA is an assessment tool designed to capture children´s perceptions of their own occupational competence together with their rating of importance of everyday activities.
21 days
Secondary Outcomes (3)
Registration of on-task-behaviour
21 days
Five to fifteen (FTF)
21 days
Strengths and Difficulties Questionnaire (SDQ)
21 days
Study Arms (2)
Intervention
EXPERIMENTALIntervention group
Control
NO INTERVENTIONControl group
Interventions
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.
Eligibility Criteria
You may qualify if:
- Children age 6-12 years, with SPD and sensory seeking behaviour as identified by the SSP, attending primary school.
You may not qualify if:
- Children with mental retardation or other massive cognitive impairment, and children who use corset or molded wheelchairs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Denmarklead
- Protac A/Scollaborator
Study Sites (1)
National Institute of Public Health
Copenhagen, 1455, Denmark
Study Officials
- PRINCIPAL INVESTIGATOR
Ann Natasja Nielsen, PhD. Student
University of Southern Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2019
First Posted
November 22, 2019
Study Start
April 1, 2020
Primary Completion
July 1, 2021
Study Completion
October 1, 2021
Last Updated
May 3, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share