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NCT04194281
Feasibility of Action Observation Training [AOT] in Infants After Unilateral Brain Lesion
NA trial testing Action Observation Training [AOT] in Perinatal Brain Injury in 8 participants. Completed in 30 July 2021.
30 July 2021
Quick facts
| Lead sponsor | Insel Gruppe AG, University Hospital Bern |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 30 May 2020 |
| Primary completion | 30 July 2021 |
| Estimated completion | 30 July 2021 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Action Observation Training [AOT]
Conditions studied
- Perinatal Brain Injury — all drugs for Perinatal Brain Injury →
Sponsor
Insel Gruppe AG, University Hospital Bern
Who can join
Adults 9 Months to 12 Months, any sex, with Perinatal Brain Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study examines whether infants with a perinatal unilateral brain lesion can perform an "Action Observation Training" \[AOT\] at the age of 9-12 months . AOT is the targeted and concentrated observation of movements and actions to learn new motor skills. In adults with hemiplegia after a stroke and in older children with hemiplegia, AOT can lead to an improvement in the functions of the affected hand/arm. Infants with early unilateral brain damage are at increased risk of developing a hemiplegia and thus impaired upper limb function. There is little known about treatment options to promote arm and hand skills in early childhood and their effectiveness. In particular, there is a lack of knowledge whether AOT could also be used in infants. It is known that even in infants at an early age brain activity can be measured while they are observing movements and infants learn a lot about observing and imitating. Knowledge about the measurement of manual skills is also reduced. So far, tests have been used to observe and evaluate how infants use their hands when playing (e.g. Mini-Assisting Hand Assessment). The aim of this study is to investigate whether measurements with motion sensors can also be used in infants. In the pre-post study, about 5 to 10 toddlers will be examined. During four weeks, the parents should give the child 20 minutes of AOT per day at home. A therapy diary will be completed for this purpose. During six weeks, the parents will use movement sensors on two days a week for the upper limb of the infants. Finally, three questionnaires about the AOT and the motion sensors will be completed by the parents.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04194281
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Perinatal Brain Injury
Currently open trials in the same condition.
- NCT07063446 — sTMS Combined With CIMT and taVNS In Infants With Hemiplegia · NA · recruiting
Other Insel Gruppe AG, University Hospital Bern trials
Trials by the same sponsor.
- NCT06546384 — GLP-1 RA on Alcohol Consumption, Metabolism and Liver Parameters in Patients With Obesity and Fatty Liver Disease · NA · not yet recruiting
- NCT07524049 — Giving Children a Voice in Paediatric Anaesthesia · not yet recruiting
- NCT07415668 — Motor Eloquent Navigated Transcranial Magnetic Stimulation for Radiosurgery Planning · NA · not yet recruiting
- NCT07478536 — Stockholm3 Test Validation in Men on Active Surveillance in Switzerland (CHAS3 Trial) · not yet recruiting
- NCT07201506 — Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04194281 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Insel Gruppe AG, University Hospital Bern
- Last refreshed: 6 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04194281.
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