Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05585424 |
| Other study ID # |
Cecilia Estrada Barranco |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
April 30, 2022 |
Study information
| Verified date |
October 2022 |
| Source |
Universidad Europea de Madrid |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
