Infant DevelopmentMaMaNCT05782673
Assessment of Motor Development With a Wearable in Rural and Low-income Settings
An observational study of Infant Development, run by Helsinki University Central Hospital at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- wearable MAIJU for motor assessment
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 15 May 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Finland2 sites
University of Helsinki
Helsinki, 00250
BABA, Clinical Trial Unit, New Children's Hospital
Helsinki
Malawi2 sites
Kamuzu University of Health Sciences
Blantyre, 3
Lungwena Health Center
Mangochi, Mangochi district
About this study
Official title: Assessment of Motor Development With a Wearable in Rural and Low-income Settings: Feasibility and Validity of MAIJU Jumpsuit in Malawi
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.
Read the 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.
- Conditions
- Infant Development
- Being tested
- wearable MAIJU for motor assessment
- Keywords
- wearable, motor development, neurodevelopment, child neurology, neurophysiology, activity tracking, developmental assessment, neurological assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable MAIJU for motor assessmentDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The primary outcome BIMS is the level reached by 18 months of age
Secondary outcomes (1)
Kilifi Developmental Inventory (KDI) score
KDI is a questionnaire based assessment of infants' neurocognitive development at 12-24 months of age. It is validated in the Malawi context. The scale is 0-70, with higher number being better.
Measured: 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start15 May 2023
- Primary completion30 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, University of Helsinki, Kamuzu University of Health Sciences
- Responsible party
- Principal investigator, Sampsa Vanhatalo, Helsinki University Central Hospital
- Investigators
- Sampsa Vanhatalo, MD PhD, Principal investigator, professor in physiology, consultant in clinical neurophysiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782673
- Sponsor's protocol ID
- MaMa2022
- Acronym
- MaMa
- Status last verified
- Sep 2025
- First submitted
- 11 Mar 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will contain sensitive information that is not allowed to share without additional permission and contracts between relevant insitutions
Publications
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.
PubMed 35721830Airaksinen 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.
PubMed 31932616
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Motor Development With a Wearable in Rural and Low-income Settings: Feasibility and Validity of MAIJU Jumpsuit in Malawi
- ClinicalTrials.gov ID
- NCT05782673
- Acronym / sponsor ID
- MaMa / MaMa2022
- Conditions
- Infant Development
- Keywords
- wearable, motor development, neurodevelopment, child neurology, neurophysiology, activity tracking, developmental assessment, neurological assessment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Tampere University, University of Helsinki, Kamuzu University of Health Sciences
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wearable MAIJU for motor assessmentThe 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. | Device | – |
Primary outcome
Motor maturation level (BIMS)
Time frame: The primary outcome BIMS is the level reached by 18 months of age
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.
1 secondary outcome
Kilifi Developmental Inventory (KDI) score
Time frame: 24 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Background: PubMed 35721830Airaksinen 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.
- Background: PubMed 31932616Airaksinen 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.
- link to presentation of the MAIJU wearableLink provided by the sponsor.
- Individual participant dataSharing planned: No. data will contain sensitive information that is not allowed to share without additional permission and contracts between relevant insitutions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sampsa Vanhatalo, MD PhD principal investigator
professor in physiology, consultant in clinical neurophysiology
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Development, run by Helsinki University Central Hospital at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland, Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor maturation level (BIMS) (time frame: The primary outcome BIMS is the level reached by 18 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05782673, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.