Assessment of Motor Development With a Wearable in Rural and Low-income Settings (NCT05782673) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Assessment of Motor Development With a Wearable in Rural and Low-income Settings
Finland, Malawi100 participantsStarted 2023-05-15
Plain-language summary
The MaMa study aims to assess feasibility and validity of an infant wearable in a rural settings. Altogether N\~100 infants will be recruited and measured multiple times at homes from age 6 months to age 18 months. Neurodevelopment of the infants is assessed at 18-24 months of age to compare motor development trajectories with the later neurodevelopmental outcome.
Who can participate
Age range
4 Months – 24 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* A documented birth date
* Birth at about term age, i.e. between 35 and 42 gestation weeks
* Mother's ability to speak fluently Chi-Chewa, Chi-Yao or English
* Permanent resident of Lungwena Health Centre catchment area
* Availability and willingness of the mother and infant during the period of the study
* Signed or thumb-printed informed consent by the caregiver of the infant
Exclusion Criteria:
* Very early birth (at 7th month or earlier) based on mother's information
* Infant's congenital malformation or severe illness as judged clinically by a study nurse
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Motor maturation level (BIMS)
Timeframe: The primary outcome BIMS is the level reached by 18 months of age