The effectiveness of an osteopathic intervention within the first five months of life measured with Prechtl's assessment of general movements and skin conductance - A Blinded Randomized Controlled Trial

The effectiveness of an osteopathic intervention within the first five months of life measured with Prechtl's assessment of general movements and skin conductance - A Blinded Randomized Controlled Trial - OGS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036314

Enrollment

Registered

2025-03-17

Start date

2025-04-08

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

reduced motor repertoire -neurological deficit-

Interventions

Group 1: The osteopathic intervention should be carried out individually and adapted to the test person. The duration of an osteopathic intervention is a maximum of 60 minutes, 5-10 minutes of osteopa

Eligibility

Sex/Gender

All

Age

12 Weeks to 16 Weeks

Inclusion criteria

Inclusion criteria: - Spontaneous birth and caesarean birth - Babies within the 12th-16th corrected week of life - MOS-R below the optimal lower limit of 25 points

Exclusion criteria

Exclusion criteria: - Premature birth - Congenital diseases - Syndromic diseases - Acquired neurological and/or metabolic diseases - Vaccinations within the last 72 hours before the first video recording and up to the third video recording - Fever within the last 72 hours before the first video recording and up to the third video recording - Medical intervention - Medication within the last 72 hours before the first video recording and up to the third video recording - alternative forms of therapy such as physiotherapy or speech therapy within one week before the first video recording and up to the third video recording - osteopathic treatment within one week before the first video recording and up to the third video recording

Design outcomes

Primary

Measure	Time frame
The primary target parameter is the measurement of the motor repertoire and motor function of the central nervous system. This is measured using the MOS-R of the GMA (Einspieler et al., 2019). In the study by Örtqvist et al. (2023), the interassessor-reliability of the MOS-R in three different populations achieved an intraclass correlation coefficient (ICC) of 0.98-0.99 (95% confidence interval), which corresponds to almost perfect agreement. The MOS-R provides positive predictive values in relation to motor, sensory or cognitive impairments (Kwong et al, 2022). The MOS-R achieved a specificity of 60% and a sensitivity of 63% (95% confidence interval) for cognitive impairments. The MOS-R can be considered a valid and reliable measurement instrument (Darsaklis et al., 2011).	—

Measure

Time frame

The primary target parameter is the measurement of the motor repertoire and motor function of the central nervous system. This is measured using the MOS-R of the GMA (Einspieler et al., 2019). In the study by Örtqvist et al. (2023), the interassessor-reliability of the MOS-R in three different populations achieved an intraclass correlation coefficient (ICC) of 0.98-0.99 (95% confidence interval), which corresponds to almost perfect agreement. The MOS-R provides positive predictive values in relation to motor, sensory or cognitive impairments (Kwong et al, 2022). The MOS-R achieved a specificity of 60% and a sensitivity of 63% (95% confidence interval) for cognitive impairments. The MOS-R can be considered a valid and reliable measurement instrument (Darsaklis et al., 2011).

—

Secondary

Measure	Time frame
The secondary target parameter is the measurement of the autonomic nervous system based on skin conductance, which is transmitted via the sweat secretion of the skin. This is measured via the number of skin conductance responses per minute (SCR/min) and the mean value of the basic level of sweat secretion using microsiemens (µS). Based on the data of the study according to Hu et al. (2021), a sensitivity of 92.31%, a specificity of 95.42% and a negative predictive value of 99.21%, but only a sufficiently positive predictive value of 66.67%, could be achieved by measuring skin conductance in 130 infants under mechanical ventilation with regard to objective pain assessment. Skin conductance can be regarded as a valid and reliable measuring instrument (Storm, 2000).	—

Measure

Time frame

The secondary target parameter is the measurement of the autonomic nervous system based on skin conductance, which is transmitted via the sweat secretion of the skin. This is measured via the number of skin conductance responses per minute (SCR/min) and the mean value of the basic level of sweat secretion using microsiemens (µS). Based on the data of the study according to Hu et al. (2021), a sensitivity of 92.31%, a specificity of 95.42% and a negative predictive value of 99.21%, but only a sufficiently positive predictive value of 66.67%, could be achieved by measuring skin conductance in 130 infants under mechanical ventilation with regard to objective pain assessment. Skin conductance can be regarded as a valid and reliable measuring instrument (Storm, 2000).

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Countries

Germany

Contacts

Public ContactBastian Makowka

laeve osteopathie

studie@laeve-osteopathie.de0176 32 32 48 31

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026