Assessment of Motor Development With a Wearable in Rural and Low-income Settings

NCT05782673 | Active Not Recruiting

• 1 other identifier: MaMa2022
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 4

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.

Conditions

Infant Development

Keywords

wearable; motor development; neurodevelopment; child neurology; neurophysiology; activity tracking; developmental assessment; neurological assessment

Outcome Measures

Primary Outcomes (1)

• Motor maturation level (BIMS)

  BIMS (Baba Infant Motility Score) is a score that combines all recorded postures and movement activities to a holistic estimate of infant's motor maturation. BIMS has a scale from 0 to 100, with higher number being better.

  The primary outcome BIMS is the level reached by 18 months of age

Secondary Outcomes (1)

• Kilifi Developmental Inventory (KDI) score

  24 months of age

Interventions

wearable MAIJU for motor assessment DEVICE

The novel multisensor wearable MAIJU will be used to measure infants' motor performance at home. The recordings are repeated at 2 months intervals betveen 6 and 18 months of age.

Eligibility Criteria

• Age: 4 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Tampere University: collaborator
• University of Helsinki: collaborator
• Kamuzu University of Health Sciences: collaborator

Study Sites (4)

University of Helsinki

Helsinki, 00250, Finland

Location

BABA, Clinical Trial Unit, New Children's Hospital

Helsinki, Finland

Location

Lungwena Health Center

Mangochi, Mangochi district, Malawi

Location

Kamuzu University of Health Sciences

Blantyre, 3, Malawi

Location

Related Publications (2)

• 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.

  PMID: 35721830 BACKGROUND

• 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.

  PMID: 31932616 BACKGROUND

Related Links

• link to presentation of the MAIJU wearable

Study Officials

• Sampsa Vanhatalo, MD PhD

  professor in physiology, consultant in clinical neurophysiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor in physiology, consultant in clinical neurophysiology

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: March 23, 2023
• Study Start: May 15, 2023
• Primary Completion: October 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2); MA (2)