General Movement concept to support the neurodevelopment of preterm with high risk for neurodevelopmental disorderns – a randomized controlled trial

General Movement concept to support the neurodevelopment of preterm with high risk for neurodevelopmental disorderns – a randomized controlled trial - GeMo_Support

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027996

Enrollment

Registered

2022-02-15

Start date

2021-10-27

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

P07.3 F82

Interventions

Group 1: Movement Imitation Therapy for Preterm Babies: Content: Imitation of normal GM sequences by parents. Frequency: 3-5 times daily Duration: up to 10 min per session for 10 weeks, 34 - 44 PMA G

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Preterm infants < 32 weeks postmenstrual age (PMA) and/or < 1500g at birth, inborn or referred to our hospital before corrected gestational age of 33 PMA. Written informed consent from parents

Exclusion criteria

Exclusion criteria: Parents with poor language skills in German, < A1 level; neonates with genetic syndromes (e.g. trisomy 21), osteoarticular diseases or fractures (e.g. due to birth trauma) or palliative care

Design outcomes

Primary

Measure	Time frame
The primary outcome of the study is the difference between the intervention and control group in terms of the children's neuromotor development and the parents' mental health. Neuromotor development is assessed by the GM Assessment at three months after the expected date of birth using the Motor Optimaility Score. Parents' mental health is assessed using the Edinburgh Postnatal Depression Scale (EPDS) and the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS).	—

Measure

Time frame

The primary outcome of the study is the difference between the intervention and control group in terms of the children's neuromotor development and the parents' mental health. Neuromotor development is assessed by the GM Assessment at three months after the expected date of birth using the Motor Optimaility Score. Parents' mental health is assessed using the Edinburgh Postnatal Depression Scale (EPDS) and the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS).

—

Secondary

Measure	Time frame
Secondary outcomes include differences in blood neurofilament levels and adherence to the intervention. Adherence is assessed by means of a mobile diary. In addition, all children will receive a follow-up with the implementation of the BSID III at the age of almost 2 years.	—

Countries

Germany

Contacts

Public ContactAnna Badura

Klinik St. Hedwig, KUNO, Universität Regensburg

anna.badura@barmherzige-regensburg.de+49 941 369-95015

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026