Sensory Processing DisorderNCT04173871
Effects of Systematic Proprioceptive-tactile Stimulation With Use of the Protac MyFit®
A study testing Protac Myfit® in people with Sensory Processing Disorder and Children, run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensory Processing Disorder, Children
- What is being tested?
- Protac Myfit®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children age 6-12 years, with SPD and sensory seeking behaviour as identified by the SSP, attending primary school.
Who cannot join
- Children with mental retardation or other massive cognitive impairment, and children who use corset or molded wheelchairs.
Trial locations and contacts
1 site in 1 country.
Åse Brandt contact
Denmark1 site, 1 recruiting
- Recruiting
National Institute of Public Health
Copenhagen, 1455
Ann Nielsen, pdh.student, +45 65 50 12 94, annnatasja@health.sdu.dk
Åse Brandt, aabrandt@health.sdu.dk
About this study
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.
Read more
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.
Read the detailed 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 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.
- Conditions
- Sensory Processing Disorder, Children
- Being tested
- Protac Myfit®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protac Myfit®Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group Receives: Device: Protac Myfit® |
| Control | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 21 days
Secondary outcomes (3)
Registration of on-task-behaviour
Study specifik registration tool.
Measured: 21 days
Five to fifteen (FTF)
A standardized questionnaire to parents, that gives an overview of a child's neuropsychological and behavioural function and examine the child´s development in different areas (181 items in total). In this study we have included the domain regarding executive functions and the subdomain of body perception in a questionnaire to the parents. Additionally, we have included the domain regarding learning in a questionnaire to the teachers.
Measured: 21 days
Strengths and Difficulties Questionnaire (SDQ)
A standardized questionnaire to teachers and parents, that screen for positive and negative psychological attributes in children age 3 - 16 years. In this study we only use the SDQ to the teachers and only the 13 items regarding school activities and social behaviour.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start1 Apr 2020
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory Processing DisorderStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Protac A/S
- Responsible party
- Sponsor
- Investigators
- Ann Natasja Nielsen, PhD. Student, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173871
- Sponsor's protocol ID
- RoTilFokus_USouthernDenmark
- Status last verified
- Apr 2021
- First submitted
- 31 Oct 2019
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Systematic Proprioceptive-tactile Stimulation With Use of the Protac MyFit®
- ClinicalTrials.gov ID
- NCT04173871
- Acronym / sponsor ID
- RoTilFokus_USouthernDenmark
- Conditions
- Sensory Processing Disorder, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Protac A/S
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Protac Myfit®Intervention group |
| Control | No intervention | –Control group |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children age 6-12 years, with SPD and sensory seeking behaviour as identified by the SSP, attending primary school.
Key exclusion criteria (1 listed)
- Children with mental retardation or other massive cognitive impairment, and children who use corset or molded wheelchairs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intervention |
Primary outcome
Test of Everyday Attention - Children (TEA-Ch)
Time frame: 21 days
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)
Child Occupational Self Assessment (COSA)
Time frame: 21 days
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.
3 secondary outcomes
Registration of on-task-behaviour
Time frame: 21 days
Five to fifteen (FTF)
Time frame: 21 days
Strengths and Difficulties Questionnaire (SDQ)
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Åse Brandt contact
Ann Natasja Nielsen, PhD. Student principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protac Myfit® in people with Sensory Processing Disorder and Children, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ann Natasja Nielsen, PhD. Student (+45 65 50 12 94, annnatasja@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Everyday Attention - Children (TEA-Ch) (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.