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

Primary Purpose

Perinatal Brain Injury

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Action Observation Training [AOT]
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perinatal Brain Injury

Eligibility Criteria

9 Months - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kinderklinik Inselspital Bern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Action Observation Therapy [AOT]

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Action Observation Training Questionnaire Part I feasibility
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).
Action Observation Training Questionnaire Part II acceptance
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).
Hand Assessment for Infants [HAI]
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).
Mini-Assisting Hand Assessment [Mini-AHA]
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).
Accelerometry
To measure the quantity of arm movements during the study period, the parents put on movement sensors for each arm of the infant.
Questionnaire Accelerometer
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).
System Usability Scale [SUS]
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).

Full Information

First Posted
December 9, 2019
Last Updated
October 5, 2021
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT04194281
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 30, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Action Observation Therapy [AOT]
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Action Observation Training [AOT]
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of and adherence to Action Observation Training in infants measured by an intervention diary
Description
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.
Time Frame
Four weeks during the Intervention
Secondary Outcome Measure Information:
Title
Action Observation Training Questionnaire Part I feasibility
Description
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).
Time Frame
Posttest, expected to be an average of 10 minutes
Title
Action Observation Training Questionnaire Part II acceptance
Description
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).
Time Frame
Posttest, expected to be an average of 10 minutes
Title
Hand Assessment for Infants [HAI]
Description
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).
Time Frame
Pre- and Posttest, expected to be an average of 15 minutes
Title
Mini-Assisting Hand Assessment [Mini-AHA]
Description
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).
Time Frame
Pre- and Posttest, expected to be an average of 15 minutes
Title
Accelerometry
Description
To measure the quantity of arm movements during the study period, the parents put on movement sensors for each arm of the infant.
Time Frame
The infants wear the accelerometers two days a week during the study duration of six weeks
Title
Questionnaire Accelerometer
Description
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).
Time Frame
Posttest, expected to be an average of 5 minutes
Title
System Usability Scale [SUS]
Description
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).
Time Frame
Posttest, expected to be an average of 5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Grunt, PD Dr. med.
Organizational Affiliation
Insel Gruppe AG, University Hospital Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kinderklinik Inselspital Bern
City
Bern
Country
Switzerland

12. IPD Sharing Statement

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

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