Clinical trial NCT04194281: Feasibility of Action Observation Training [AOT] in Infants After Unilateral Brain Lesion
Official title: Action Observation Training [AOT] to Improve Upper Limb Function in Infants After Unilateral Brain Lesion - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Brain Injury
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 8
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Premature and term-born infants aged 9-12 months
* Perinatal unilateral brain damage due to cerebral hemorrhage or stroke
* Informed consent to study participation by the parents or legal representative

Exclusion Criteria:

* Infants with impaired vision
* Other diagnoses than early childhood brain damage affecting the functions of the upper extremities (e.g. plexus palsy)
* Infants who participate in other studies of upper extremity interventions
* Parents do not understand the study and the intervention due to foreign language skills

Primary outcomes:
measure: Feasibility of and adherence to Action Observation Training in infants measured by an intervention diary
timeFrame: Four weeks during the Intervention
Secondary outcomes:
measure: Action Observation Training Questionnaire Part I feasibility
timeFrame: Posttest, expected to be an average of 10 minutes
measure: Action Observation Training Questionnaire Part II acceptance
timeFrame: Posttest, expected to be an average of 10 minutes
measure: Hand Assessment for Infants [HAI]
timeFrame: Pre- and Posttest, expected to be an average of 15 minutes
measure: Mini-Assisting Hand Assessment [Mini-AHA]
timeFrame: Pre- and Posttest, expected to be an average of 15 minutes
measure: Accelerometry
timeFrame: The infants wear the accelerometers two days a week during the study duration of six weeks
measure: Questionnaire Accelerometer
timeFrame: Posttest, expected to be an average of 5 minutes
measure: System Usability Scale [SUS]
timeFrame: Posttest, expected to be an average of 5 minutes
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Kinderklinik Inselspital Bern
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Sebastian Grunt, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: