Perinatal Brain InjuryNCT04194281
Feasibility of Action Observation Training [AOT] in Infants After Unilateral Brain Lesion
A study testing Action Observation Training [AOT] in people with Perinatal Brain Injury, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 12 months
- Conditions the study is for
- Perinatal Brain Injury
- What is being tested?
- Action Observation Training [AOT]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 May 2020to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Action Observation Training [AOT] to Improve Upper Limb Function in Infants After Unilateral Brain Lesion - a Feasibility Study
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
- Being tested
- Action Observation Training [AOT]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Action Observation Therapy [AOT] | Experimental | Not described Receives: Other: Action Observation Training [AOT] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks during the Intervention
Secondary outcomes (7)
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).
Measured: Posttest, expected to be an average of 10 minutes
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).
Measured: Posttest, expected to be an average of 10 minutes
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).
Measured: Pre- and Posttest, expected to be an average of 15 minutes
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).
Measured: Pre- and Posttest, expected to be an average of 15 minutes
Accelerometry
To measure the quantity of arm movements during the study period, the parents put on movement sensors for each arm of the infant.
Measured: The infants wear the accelerometers two days a week during the study duration of six weeks
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).
Measured: Posttest, expected to be an average of 5 minutes
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).
Measured: Posttest, expected to be an average of 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start30 May 2020
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal Brain InjuryStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Grunt, PD Dr. med., Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194281
- Sponsor's protocol ID
- 2019-02028
- Other IDs
- 2019
- Status last verified
- Oct 2021
- First submitted
- 9 Dec 2019
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action Observation Training [AOT] to Improve Upper Limb Function in Infants After Unilateral Brain Lesion - a Feasibility Study
- ClinicalTrials.gov ID
- NCT04194281
- Acronym / sponsor ID
- 2019-02028
- Conditions
- Perinatal Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 30 May 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Action Observation Therapy [AOT] | Experimental | Other: Action Observation Training [AOT] |
Who may qualify
- Ages
- 9 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Observation Training [AOT]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. | Other | Action Observation Therapy [AOT] |
Primary outcome
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.
7 secondary outcomes
Action Observation Training Questionnaire Part I feasibility
Time frame: Posttest, expected to be an average of 10 minutes
Action Observation Training Questionnaire Part II acceptance
Time frame: Posttest, expected to be an average of 10 minutes
Hand Assessment for Infants [HAI]
Time frame: Pre- and Posttest, expected to be an average of 15 minutes
Mini-Assisting Hand Assessment [Mini-AHA]
Time frame: Pre- and Posttest, expected to be an average of 15 minutes
Accelerometry
Time frame: The infants wear the accelerometers two days a week during the study duration of six weeks
Questionnaire Accelerometer
Time frame: Posttest, expected to be an average of 5 minutes
System Usability Scale [SUS]
Time frame: Posttest, expected to be an average of 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
Related trials for Perinatal Brain Injury
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
Not yet recruitingPhase 2/3
Intranasal Stem Cells to Treat Perinatal Brain Injury to Combat Cerebral Palsy
Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia
RecruitingObservational study
Baby Brain Recovery Study
Perinatal Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Grunt, PD Dr. med. principal investigator
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation Training [AOT] in people with Perinatal Brain Injury, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of and adherence to Action Observation Training in infants measured by an intervention diary (time frame: Four weeks during the Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.