Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT03714256
Eligibility Criteria:
Inclusion Criteria:
Primary users:
* Informed consent signed by parents or guardian
* Aged 6-36 months
* Unable to mobilize independently for exploratory play and peer interaction, as categorized by Hays (1987)
* Adequate trunk and head control to remain upright in the device, including regain head control
* Adequate hand/ arm (distal) control to reach for objects in front of them
Secondary users:
* Signed informed consent
* Physiotherapist/Occupational Therapist or parent/guardian of the child included in the test
Exclusion Criteria:
* Primary users:
* Weight \>16 kg/35 Ibs
* Length \>100 cm/39 In
* Children that lack head control in such a severe manner that they cannot regain control if it is lost
* Children who do not show awareness of or respond to toys, objects, sounds and/or people in their environment
* Any other reason, if in the opinion of the investigator, the individual user is not appropriate, or suitable for participation in the test.
Secondary users:
* Hearing/vision loss or limited cognitive skills impacting the ability to take instructions and perform the tasks of the test
* Ability to understand oral and written English as product labelling will in this Human Factor validation test only be available in English
* Any other reason, if in the opinion of the investigator, the individual user is not appropriate, or suitable for participation in the test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
36 Months
Study:
NCT03714256
Study Brief:
Protocol Section:
NCT03714256