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NCT Number: NCT04194281

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

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.

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Key information

Conditions

Perinatal Brain Injury

Age range

9 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kinderklinik Inselspital Bern

Bern, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Four weeks during the Intervention

    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.

Secondary outcomes

  1. Action Observation Training Questionnaire Part I feasibility

    Time frame: Posttest, expected to be an average of 10 minutes

    The parents fill out a questionnaire about the feasibility of AOT with a minimum score of 0 and a maximum score of 19 (higher score means better feasibility).

  2. Action Observation Training Questionnaire Part II acceptance

    Time frame: Posttest, expected to be an average of 10 minutes

    The parents fill out a questionnaire about their acceptance of AOT with a minimum score of 0 and a maximum score of 24 (higher score means better feasibility).

  3. Hand Assessment for Infants [HAI]

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

    The HAI ist a descriptive and evaluative assessment of upper limb function for use with infants aged 3 to 12 months at risk of unilateral cerebral palsy. The HAI measures the use of both hands and quantifies a possible asymmetry of hand use. The age-appropriate play situation is recorded on video. The score ranges from 0 to 100 HAI-Units (the higher the score the better the hand function).

  4. Mini-Assisting Hand Assessment [Mini-AHA]

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

    The Mini-AHA measures and describes how effectively infants with unilateral cerebral palsy at the age of 8 to 18 months use their affected hand in bimanual Play. A semi-structured age-appropriate play situation is recorded on video. The score ranges from 0 to 100 Mini-AHA-Units (the higher the score the better the hand function).

  5. Accelerometry

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

    To measure the quantity of arm movements during the study period, the parents put on movement sensors for each arm of the infant.

  6. Questionnaire Accelerometer

    Time frame: Posttest, expected to be an average of 5 minutes

    To assess the feasibility of accelerometers in infants, the parents fill out a questionnaire about their experience. The score ranges from 0 to 40 (the higher the score the better the result).

  7. System Usability Scale [SUS]

    Time frame: Posttest, expected to be an average of 5 minutes

    To assess the usability of accelerometers, the parents fill out the SUS with questions about their experiences with the system. The scale ranges from 0 to 100 (the higher the score the better the Usability).

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Action Observation Training [AOT] to Improve Upper Limb Function in Infants After Unilateral Brain Lesion - a Feasibility Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2019
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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