Clinical trial NCT05782673: Assessment of Motor Development With a Wearable in Rural and Low-income Settings
Official title: Assessment of Motor Development With a Wearable in Rural and Low-income Settings: Feasibility and Validity of MAIJU Jumpsuit in Malawi
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infant Development
Keywords: wearable
motor development
neurodevelopment
child neurology
neurophysiology
activity tracking
developmental assessment
neurological assessment
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University
name: University of Helsinki
name: Kamuzu University of Health Sciences
First posted: 2023-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All infants born in the catchment area of Lungwena health center are screened, and the infants are contacted if they fullfil the eligibility criteria.

Brief 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.

Detailed description: The MaMa study aims to assess the feasibility and validity of an infant wearable method to study young infants' neuromotor development in a low income setting. In this method, infants' motor abilities (e.g. variety of different postures and movement types) are measured using a playsuit equipped with movement sensors while the infant is freely playing in his/her native environment, such as home. The data recorded with the wearable sensors is analysed afterwards using an algorithm that quantifies individual movement and posture components as well as delivers holistic interpretations of infant's motor maturity. This method is developed in University of Helsinki, and it is already successfully used in clinical research projects in Finland, Denmark, Italy and USA. Use of movement sensors is common in other wellness and health applications, however wearables of this kind have not been used before for infant's neuromotor assessment. The solution has the advantage that it provides a fully objective and quantified representation of infant's motor activity in his/her native environment; which is not achievable with any of the currently used clinical assessment methods that are typically performed in the outpatient clinic environment.

The study will be conducted in rural Malawi, is East Africa. The investigators will assess the feasibility of the wearable method in a resource poor setting by running a pilot study on approximately five-to-seven-month-old infants. In the first phase, the investigators will assess technical suitability of wearable methods in 20 typically developing infants in the rural settings, and compare the results to those obtained from infants of the same age in Finland. In the second phase, the study will continue as a longitudinal follow-up of these infants and recruit a larger study group of Malawian infants (up to a total N\~100), all of whom will undergo repeated assessment with the wearable method, every 6 weeks until the age of 18 months, or until they walk fluently. The results will support constructing motor growth charts for the Malawian infant population. At the age of 24 months, children's neuropsychological performance will be assessed using an assessment battery that was recently adapted for Malawian context; this will allow us to study how early motor development associates with later neurocognitive developmental profile.

There are three potential benefits from performing the study. First, to establish the practical feasibility and utility of a novel method for out-of-hospital neurological assessment in infants. Second, the project will establish functional motor growth charts for Malawian population to serve as a benchmark in any future intervention trial in comparable environments; these can be also compared to data from Finland. Finally, the project will allow assessing links between early motor and later cognitive development, a question with significant global health implications in all cultures.

Eligibility 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

Primary outcomes:
measure: Motor maturation level (BIMS)
timeFrame: The primary outcome BIMS is the level reached by 18 months of age
Secondary outcomes:
measure: Kilifi Developmental Inventory (KDI) score
timeFrame: 24 months of age
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki
city: Helsinki
country: Finland
facility: BABA, Clinical Trial Unit, New Children's Hospital
city: Mangochi
country: Malawi
facility: Lungwena Health Center
state: Mangochi district
city: Blantyre
country: Malawi
facility: Kamuzu University of Health Sciences
Study officials:
affiliation: professor in physiology, consultant in clinical neurophysiology
name: Sampsa Vanhatalo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Airaksinen M, Gallen A, Kivi A, Vijayakrishnan P, Hayrinen T, Ilen E, Rasanen O, Haataja LM, Vanhatalo S. Intelligent wearable allows out-of-the-lab tracking of developing motor abilities in infants. Commun Med (Lond). 2022 Jun 15;2:69. doi: 10.1038/s43856-022-00131-6. eCollection 2022.
citation: Airaksinen M, Rasanen O, Ilen E, Hayrinen T, Kivi A, Marchi V, Gallen A, Blom S, Varhe A, Kaartinen N, Haataja L, Vanhatalo S. Automatic Posture and Movement Tracking of Infants with Wearable Movement Sensors. Sci Rep. 2020 Jan 13;10(1):169. doi: 10.1038/s41598-019-56862-5.