Clinical trial NCT05585424: Effectiveness of a Program Based on Observation-action Training (AOT) in Patients With Cognitive Impairment.
Official title: Effectiveness of a Program Based on Observation-action Training (AOT) on Motor, Functional and Cognitive Aspects in Patients With Cognitive Impairment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairments
Keywords: Action observation treatment
Cognitive impairment
Mirror neurons
Elderly people
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 44
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: nonranzomized controlled trial study
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Upper limb functionality measured with upper limb subsection of the Fugl Meyer scale
timeFrame: one month
measure: Independence in activities of daily living measured with Barthel Índex
timeFrame: one month
measure: Cognitive impairment measured with Mini-Mental State Examination (MMSE)
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Villaviciosa De Odón
country: Spain
facility: Cecilia Estrada Barranco
state: Madrid
Study officials:
affiliation: Universidad Europea de Madrid
name: Cecilia Estrada Barranco, Dra
role: PRINCIPAL_INVESTIGATOR
References: