Feasibility of Action Observation Training [AOT] in Infants After Unilateral Brain Lesion

NCT04194281 | Completed DMC

• 1 other identifier: 2019-02028
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Brain Injury

Outcome Measures

Primary Outcomes (1)

• Feasibility of and adherence to Action Observation Training in infants measured by an intervention diary

  To assess the adherence of the intervention the parents fill out a diary. In addition to the training duration in minutes per day, the number of training sequences, the persons involved, the content of the AOT and the attention, motivation and imitation behaviour of the child should also be documented. The parents are asked to write down further comments on the form which may contribute to a better understanding.

  Four weeks during the Intervention

Secondary Outcomes (7)

• Action Observation Training Questionnaire Part I feasibility

  Posttest, expected to be an average of 10 minutes

• Action Observation Training Questionnaire Part II acceptance

  Posttest, expected to be an average of 10 minutes

• Hand Assessment for Infants [HAI]

  Pre- and Posttest, expected to be an average of 15 minutes

• Mini-Assisting Hand Assessment [Mini-AHA]

  Pre- and Posttest, expected to be an average of 15 minutes

• Accelerometry

  The infants wear the accelerometers two days a week during the study duration of six weeks

Study Arms (1)

Action Observation Therapy [AOT]

EXPERIMENTAL

Other: Action Observation Training [AOT]

Interventions

Action Observation Training [AOT] OTHER

Parents are instructed to show their child repetitive arm, hand and finger movements in a playful and age-appropriate way for about 20 minutes a day, divided into several short sequences. AOT is to be carried out for four weeks at home by the parents and, if necessary, other caregivers. The parents receive instructions which contain background information on the possible importance of AOT for improving the functions of the upper limb, information about positions, promoting motivation, attention and interest as well as tips for promoting movement observation in everyday life.

Action Observation Therapy [AOT]

Eligibility Criteria

• Age: 9 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Kinderklinik Inselspital Bern

Bern, Switzerland

Location

Study Officials

• Sebastian Grunt, PD Dr. med.

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: May 30, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

CH (1)