Effectiveness of a Program Based on Observation-action Training (AOT) in Patients With Cognitive Impairment.

NCT05585424 | Completed

• 1 other identifier: Cecilia Estrada Barranco
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairments

Keywords

Action observation treatment; Cognitive impairment; Mirror neurons; Elderly people

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  one month

Study Arms (2)

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

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.

Interventions

AOT intervention OTHER

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.

Experimental Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Cecilia Estrada Barranco

Villaviciosa de Odón, Madrid, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Cecilia Estrada Barranco, Dra

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in health sciences

Model Details: nonranzomized controlled trial study

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 18, 2022
• Study Start: March 1, 2022
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)