Assessing infant motor development using a wearable device in rural Malawi
Assessment of Motor Development With a Wearable in Rural and Low-income Settings: Feasibility and Validity of MAIJU Jumpsuit in Malawi
Helsinki University Central Hospital · NCT05782673
This study is testing a special playsuit with movement sensors to see how well it can track motor development in infants living in rural Malawi.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 4 Months to 24 Months |
| Sex | All |
| Sponsor | Helsinki University Central Hospital (other) |
| Locations | 4 sites (Helsinki and 3 other locations) |
| Trial ID | NCT05782673 on ClinicalTrials.gov |
What this trial studies
The MaMa study evaluates the feasibility and validity of a wearable device designed to monitor motor development in infants living in low-income rural settings. Approximately 100 infants aged 6 to 18 months will be recruited, and their motor abilities will be assessed using a playsuit equipped with movement sensors while they play in their home environment. The data collected will be analyzed to quantify individual movement and posture components, providing an objective assessment of motor maturity. This innovative approach aims to improve understanding of infant neurodevelopment in resource-poor settings.
Who should consider this trial
Good fit: Ideal candidates are infants aged 5 to 7 months who are permanent residents of the Lungwena Health Centre catchment area.
Not a fit: Patients who may not benefit include those with congenital malformations or severe illnesses, as well as infants born very prematurely.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for assessing infant motor development in low-resource environments, leading to better early interventions.
How similar studies have performed: While the use of wearables for health monitoring is common, this specific application for infant neuromotor assessment is novel and has not been extensively tested in similar settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Helsinki and 3 other locations
- University of Helsinki — Helsinki, Finland (ACTIVE_NOT_RECRUITING)
- BABA, Clinical Trial Unit, New Children's Hospital — Helsinki, Finland (ACTIVE_NOT_RECRUITING)
- Lungwena Health Center — Mangochi, Mangochi district, Malawi (RECRUITING)
- Kamuzu University of Health Sciences — Blantyre, Malawi (ACTIVE_NOT_RECRUITING)
Study contacts
- Principal investigator: Sampsa Vanhatalo, MD PhD — professor in physiology, consultant in clinical neurophysiology
- Study coordinator: Sampsa Vanhatalo, MD PhD
- Email: sampsa.vanhatalo@helsinki.fi
- Phone: 00358505286119
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infant Development, wearable, motor development, neurodevelopment, child neurology, neurophysiology, activity tracking, developmental assessment