Cognitive ImpairmentsNCT05585424
Effectiveness of a Program Based on Observation-action Training (AOT) in Patients With Cognitive Impairment.
A study testing AOT intervention in people with Cognitive Impairments, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
The objective of this study is to assess motor and social interaction changes after AOT intervention in patients with mild cognitive impairment and Moderate cognitive impairment. The planned sample size is 11 pairs in the experimental group and 11 pairs in the control group. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairments
- What is being tested?
- AOT intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2022to 30 Apr 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Institutionalised patients over 65 years of age.
- Mild cognitive impairment (minimental test between 19 and 23) or moderate cognitive impairment (minimental test 14-18);
- Patients supervised by geriatric or nursing assistants during basic activities of daily living
Who cannot join
- Patients with musculoskeletal and neuro-musculoskeletal pathology of the dominant upper limb (outside MCI and MCI);
- Presentation of visual deficit not correctable with glasses;
- Patient with aggressive behavioural disturbance or emotional lability;
- Patient with severe hypoacusis not correctable with hearing aids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Program Based on Observation-action Training (AOT) on Motor, Functional and Cognitive Aspects in Patients With Cognitive Impairment.
The objective of this study is to assess motor and social interaction changes after AOT intervention in patients with mild cognitive impairment and Moderate cognitive impairment.
The planned sample size is 11 pairs in the experimental group and 11 pairs in the control group. Each group will be composed of eleven subjects with moderate cognitive impairment (MCI) and eleven with mild cognitive impairment (MCI), assessed by the minimental test. During the sessions, the MCI patient will observe his MCI partner and perform a programme of motor activities for the upper limb. At the same time the mild patient imitates the movement performed by the physiotherapist, all based on the AOT.
Read more
The activities will be based on items of the FUGL-MEYER scale. Data will be collected at the functional level, with respect to motor changes and also social modifications that have been perceived by the participants, carers and therapists.
The variables considered in this study are, as primary variables, motor changes, using the Fugl-Meyer scale, and perception with respect to social interaction; as well as mood. The latter two will be collected through interviews with patients, caregivers and therapists.
The impact on patient independence (Barthel index score) will also be considered. Finally, data will be analysed using SPSS statistical software. Non-parametric tests for related samples will be used in order to study changes in the variables collected before and after the intervention. The sample will be recruited from the old people's home "Nuestra Señora de la Soledad" in Parla, Madrid (collaboration agreement attached) depending on whether or not they meet the inclusion criteria.
Read the detailed description
Previous work has demonstrated the effectiveness of observational learning. A previous study on children with cerebral palsy "Efficacy of a home-based platform for child-to-child interaction on hand motor function in unilateral cerebral palsy" presented by Naura, Avanzini, Rizzolatti and Fabbri-Destro, showed that motor learning by observation is greater and presents more evident benefits when subjects learn from other patients with the same condition and less severity than when they learn by observing the therapist or another person without motor impairment. This work seeks to measure the improvements, both motor, functional and social, that patients with cognitive impairment can achieve with such an intervention.
This work is an experimental study based on the stimulation of mirror neurons. The planned sample size is 11 pairs in the experimental group and 11 pairs in the control group. Each group will be composed of eleven subjects with moderate cognitive impairment (MCI) and eleven with mild cognitive impairment (MCI), assessed by the minimental test. During the sessions, the MCI patient will observe his MCI partner and perform a programme of motor activities for the upper limb. At the same time the mild patient imitates the movement performed by the physiotherapist, all based on the AOT.
The activities will be based on items of the FUGL-MEYER scale. The sessions will last between 15 and 20 minutes and will be held three days a week. The intervention will last 5 weeks, with an initial assessment, 11 intervention sessions and a final assessment.
Inclusion criteria are: institutionalised patients over 65 years of age with mild cognitive impairment (minimental test between 19 and 23) or moderate cognitive impairment (minimental test 14-18); patients who perform physiotherapy exercises twice a week or attend occupational therapy twice a week; patients supervised by geriatric assistants or nurses during basic activities of daily living.
Exclusion criteria are considered to be: patients with musculoskeletal and neuro-musculoskeletal pathology of the dominant upper limb (outside MCI and MCI); presentation of visual deficit not correctable with glasses; patients with aggressive behavioural alterations or emotional lability; presentation of severe hypoacusis not correctable with hearing aids.
Data will be collected at the functional level, with respect to motor changes and also social modifications that have been perceived by the participants, carers and therapists.
The variables considered in this study are, as primary variables, motor changes, using the Fugl-Meyer scale, and perception with respect to social interaction; as well as mood. The latter two will be collected through interviews with patients, caregivers and therapists.
As secondary variables, functional changes in feeding (feeding time, errors in food intake, accuracy in bringing food to the mouth) will be considered. The impact on patient independence (Barthel index score) will also be considered. Finally, data will be analysed using SPSS statistical software. Non-parametric tests for related samples will be used in order to study changes in the variables collected before and after the intervention. The sample will be recruited from the old people's home "Nuestra Señora de la Soledad" in Parla, Madrid (collaboration agreement attached) depending on whether or not they meet the inclusion criteria.
Participants and/or legal representatives will sign an informed consent form once they have decided to participate after having received an information sheet with a detailed description of the study procedure and clarification of any doubts they may have (attached below). A consent form for the recording of patients during the assessments is also attached. The patient's personal data are coded in order to maintain their anonymity.
The handling and confidentiality of the data will be carried out in accordance with the regulations in force and following the Organic Law 3/2018, on the Protection of Personal Data and guarantee of digital rights.
- Conditions
- Cognitive Impairments
- Being tested
- AOT intervention
- Keywords
- Action observation treatment, Cognitive impairment, Mirror neurons, Elderly people
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOT interventionOther
The treatment will last 4 weeks, with an intensity of 3 sessions per week. During the sessions the MCI patient will observe his MCI partner and perform a programme of upper limb motor activities. At the same time the mild patient imitates the movement performed by the physiotherapist, all based on the AOT.
The activities will be based on items of the FUGL-MEYER scale. The sessions will last between 15 and 20 minutes and will be held three days a week. The intervention will last 5 weeks, with an initial assessment, 11 intervention sessions and a final assessment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients in the experimental group were paired so that each patient with MCI faced a patient with ModCI. During the sessions, two therapists performed the upper limb activities that only the MCI patients could see and they performed them by imitation Receives: Other: AOT intervention |
| Control group | No intervention | The CG was assessed at baseline and after one month and continued with their usual activities in the nursing home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb functionality measured with upper limb subsection of the Fugl Meyer scale
The upper limb subsection has 33 items, with the maximum score of 66 being associated with the best upper limb motor function and 0 being the minimum score
Measured: one month
Independence in activities of daily living measured with Barthel Índex
here are 10 items that add up to 5 or 10 points and total up to a maximum of 100 when the person is independent in BADLs
Measured: one month
Cognitive impairment measured with Mini-Mental State Examination (MMSE)
The MMSE assesses different cognitive functions (orientation, memory, attention and calculation, language, construction, praxis and reasoning). The maximum score is 30. A score of 23 or lower is associated with cognitive impairment.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Mar 2022
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentsStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- nonranzomized controlled trial study
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Estrada Barranco, Universidad Europea de Madrid
- Investigators
- Cecilia Estrada Barranco, Dra, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585424
- Sponsor's protocol ID
- Cecilia Estrada Barranco
- Status last verified
- Oct 2022
- First submitted
- 11 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Program Based on Observation-action Training (AOT) on Motor, Functional and Cognitive Aspects in Patients With Cognitive Impairment.
- ClinicalTrials.gov ID
- NCT05585424
- Acronym / sponsor ID
- Cecilia Estrada Barranco
- Conditions
- Cognitive Impairments
- Keywords
- Action observation treatment, Cognitive impairment, Mirror neurons, Elderly people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 18 Oct 2022 (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 objective of this study is to assess motor and social interaction changes after AOT intervention in patients with mild cognitive impairment and Moderate cognitive impairment.
The planned sample size is 11 pairs in the experimental group and 11 pairs in the control group. Each group will be composed of eleven subjects with moderate cognitive impairment (MCI) and eleven with mild cognitive impairment (MCI), assessed by the minimental test. During the sessions, the MCI patient will observe his MCI partner and perform a programme of motor activities for the upper limb. At the same time the mild patient imitates the movement performed by the physiotherapist, all based on the AOT.
The activities will be based on items of the FUGL-MEYER scale. Data will be collected at the functional level, with respect to motor changes and also social modifications that have been perceived by the participants, carers and therapists.
The variables considered in this study are, as primary variables, motor changes, using the Fugl-Meyer scale, and perception with respect to social interaction; as well as mood. The latter two will be collected through interviews with patients, caregivers and therapists.
The impact on patient independence (Barthel index score) will also be considered. Finally, data will be analysed using SPSS statistical software. Non-parametric tests for related samples will be used in order to study changes in the variables collected before and after the intervention. The sample will be recruited from the old people's home "Nuestra Señora de la Soledad" in Parla, Madrid (collaboration agreement attached) depending on whether or not they meet the inclusion criteria.
Detailed description
Previous work has demonstrated the effectiveness of observational learning. A previous study on children with cerebral palsy "Efficacy of a home-based platform for child-to-child interaction on hand motor function in unilateral cerebral palsy" presented by Naura, Avanzini, Rizzolatti and Fabbri-Destro, showed that motor learning by observation is greater and presents more evident benefits when subjects learn from other patients with the same condition and less severity than when they learn by observing the therapist or another person without motor impairment. This work seeks to measure the improvements, both motor, functional and social, that patients with cognitive impairment can achieve with such an intervention.
This work is an experimental study based on the stimulation of mirror neurons. The planned sample size is 11 pairs in the experimental group and 11 pairs in the control group. Each group will be composed of eleven subjects with moderate cognitive impairment (MCI) and eleven with mild cognitive impairment (MCI), assessed by the minimental test. During the sessions, the MCI patient will observe his MCI partner and perform a programme of motor activities for the upper limb. At the same time the mild patient imitates the movement performed by the physiotherapist, all based on the AOT.
The activities will be based on items of the FUGL-MEYER scale. The sessions will last between 15 and 20 minutes and will be held three days a week. The intervention will last 5 weeks, with an initial assessment, 11 intervention sessions and a final assessment.
Inclusion criteria are: institutionalised patients over 65 years of age with mild cognitive impairment (minimental test between 19 and 23) or moderate cognitive impairment (minimental test 14-18); patients who perform physiotherapy exercises twice a week or attend occupational therapy twice a week; patients supervised by geriatric assistants or nurses during basic activities of daily living.
Exclusion criteria are considered to be: patients with musculoskeletal and neuro-musculoskeletal pathology of the dominant upper limb (outside MCI and MCI); presentation of visual deficit not correctable with glasses; patients with aggressive behavioural alterations or emotional lability; presentation of severe hypoacusis not correctable with hearing aids.
Data will be collected at the functional level, with respect to motor changes and also social modifications that have been perceived by the participants, carers and therapists.
The variables considered in this study are, as primary variables, motor changes, using the Fugl-Meyer scale, and perception with respect to social interaction; as well as mood. The latter two will be collected through interviews with patients, caregivers and therapists.
As secondary variables, functional changes in feeding (feeding time, errors in food intake, accuracy in bringing food to the mouth) will be considered. The impact on patient independence (Barthel index score) will also be considered. Finally, data will be analysed using SPSS statistical software. Non-parametric tests for related samples will be used in order to study changes in the variables collected before and after the intervention. The sample will be recruited from the old people's home "Nuestra Señora de la Soledad" in Parla, Madrid (collaboration agreement attached) depending on whether or not they meet the inclusion criteria.
Participants and/or legal representatives will sign an informed consent form once they have decided to participate after having received an information sheet with a detailed description of the study procedure and clarification of any doubts they may have (attached below). A consent form for the recording of patients during the assessments is also attached. The patient's personal data are coded in order to maintain their anonymity.
The handling and confidentiality of the data will be carried out in accordance with the regulations in force and following the Organic Law 3/2018, on the Protection of Personal Data and guarantee of digital rights.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- nonranzomized controlled trial study
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: AOT interventionPatients in the experimental group were paired so that each patient with MCI faced a patient with ModCI. During the sessions, two therapists performed the upper limb activities that only the MCI patients could see and they performed them by imitation |
| Control group | No intervention | –The CG was assessed at baseline and after one month and continued with their usual activities in the nursing home. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Institutionalised patients over 65 years of age.
- Mild cognitive impairment (minimental test between 19 and 23) or moderate cognitive impairment (minimental test 14-18);
- Patients supervised by geriatric or nursing assistants during basic activities of daily living
Key exclusion criteria (4 listed)
- Patients with musculoskeletal and neuro-musculoskeletal pathology of the dominant upper limb (outside MCI and MCI);
- Presentation of visual deficit not correctable with glasses;
- Patient with aggressive behavioural disturbance or emotional lability;
- Patient with severe hypoacusis not correctable with hearing aids.
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 |
|---|---|---|
| AOT interventionThe treatment will last 4 weeks, with an intensity of 3 sessions per week. During the sessions the MCI patient will observe his MCI partner and perform a programme of upper limb motor activities. At the same time the mild patient imitates the movement performed by the physiotherapist, all based on the AOT. The activities will be based on items of the FUGL-MEYER scale. The sessions will last between 15 and 20 minutes and will be held three days a week. The intervention will last 5 weeks, with an initial assessment, 11 intervention sessions and a final assessment. | Other | Experimental Group |
Primary outcome
Upper limb functionality measured with upper limb subsection of the Fugl Meyer scale
Time frame: one month
The upper limb subsection has 33 items, with the maximum score of 66 being associated with the best upper limb motor function and 0 being the minimum score
Independence in activities of daily living measured with Barthel Índex
Time frame: one month
here are 10 items that add up to 5 or 10 points and total up to a maximum of 100 when the person is independent in BADLs
Cognitive impairment measured with Mini-Mental State Examination (MMSE)
Time frame: one month
The MMSE assesses different cognitive functions (orientation, memory, attention and calculation, language, construction, praxis and reasoning). The maximum score is 30. A score of 23 or lower is associated with cognitive impairment.
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 18 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Cecilia Estrada Barranco, Dra principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AOT intervention in people with Cognitive Impairments, run by Universidad Europea de Madrid at 1 site in Spain.
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 18 Oct 2022. 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 Spain. 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?
Upper limb functionality measured with upper limb subsection of the Fugl Meyer scale (time frame: one month). The study lists 3 primary outcomes in all. 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 18 Oct 2022.