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

Summary

Participation Requirements

Description

The purpose of the study is to investigate the effect of systematic proprioceptive-tactile stimulation through use of the Protac MyFit® to children, age 6-12 years with SPD and sensory seeking behavior. The primary objective is to determine the effect of the vest on the children´s abilities for atte...

The purpose of the study is to investigate the effect of systematic proprioceptive-tactile stimulation through use of the Protac MyFit® to children, age 6-12 years with SPD and sensory seeking behavior. The primary objective is to determine the effect of the vest on the children´s abilities for attention and participation in school activities, and secondary their abilities for on-task behavior and feelings of self-esteem and self-efficacy. Method & design The study is a randomized controlled trial (RCT), were primary school children with SPD and sensory seeking behavior receives an intervention with systematic proprioceptive-tactile stimulation through use of the Protac MyFit®. Study setting and participants The study will be conducted in public primary schools across Denmark. Participants will be 240 children with SPD and sensory seeking behaviour age 6-12 years attending public primary school. Sample size has been calculated based on results from the feasibility study and the primary outcome of sustained attention measured with the Test of Every Day Attention-Children. The sample size is calculated with Ancova analysis and made with an anticipated difference on 1.5 with a correlation of .07 and a standard deviation at 5. Recruitment and randomization Recruitment will be conducted in collaboration with gatekeepers from municipal Pedagogical Psychological Counselling (PPR) departments and public-school managements across Denmark, that will assist in identifying possible study participants. Parents to possible participants will be introduced to the study by the gatekeepers and handed out written information about the study together with a baseline questionnaire, the Short Sensory Profile questionnaire (SSP), a consent form for participation and a franked reply envelope. The included children will be randomized into two groups; an intervention group (A) and a control group (B). The randomization will be computer generated 1:1. Additionally, 20 of the included children will be strategically selected (as per age, gender, group) to represent the main population and complete a qualitative research interview regarding their experiences of using the MyFit®. Intervention The intervention consisted of systematic proprioceptive-tactile stimulation by the MyFit®, were the children are asked to wear the vest from the beginning of every school day within the study period. Additionally, the participants are invited to use the vest as they please at home and doing leisure activities. At baseline participants try out and chose whether they wish to use a vest with balls 25mm or 38mm in diameter. Doing the test period participants in both group A and B will receive the usual treatment as provided by the PPR departments, the school and/or the family doctor. Usual treatment offered by PPR and schools can vary between municipalities, it can be in form of physical therapy, occupational therapy, increased support doing school activities etc. This will be registered and described throughout the study. Parents of participant are asked to document if the child receive any other treatment medical or otherwise. Participation in the study will be voluntary and the families will be informed that they at any time can withdraw from the study and that the child should never be forced to use the vest.

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