Effectiveness of an Intervention Using Observation/Action Therapy Among Patients With Mild Cognitive Impairment

NCT05934344 | Unknown

• 1 other identifier: Universidad Europea
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Mild cognitive impairment (MCI) is a transitional state between normal aging and early dementia, characterized by memory deficits without functional impairment. Cognitive decline prevalence is increasing in older adults, impacting independence and quality of life. Motor dysfunctions, often overlooked in MCI, contribute to these limitations. Action Observation Therapy (AOT), a rehabilitation approach involving observing and imitating motor gestures, promotes brain plasticity through the mirror neuron system. While AOT has shown effectiveness in various populations, its application in MCI is understudied. This study aims to investigate the effects of AOT on cognition, upper and lower limb function, daily activities, gait, and balance in MCI patients. It also compares outcomes when patients observe therapists or MCI individuals with similar characteristics. Primary objectives include comparing AOT efficacy between these groups and a control group. Secondary objectives focus on upper limb functionality, daily activities, balance, cognition, and gait.

Conditions

Mild Cognitive Impairment; Age-associated Memory Impairment

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Changes cognitive impairment

  Montreal Cognitive Assessment (MoCA)

  Before and after the intervention: 5 weeks

• Changes Activities of daily living

  Barthel index

  Before and after the intervention: 5 weeks

• Changes Functionality

  Fugl-meyer scale

  Before and after the intervention: 5 weeks

• Changes Upper limb dexterity

  Box and block test

  Before and after the intervention: 5 weeks

• Changes balance

  Berg Balance Scale

  Before and after the intervention: 5 weeks

• Changes gait

  10 Meters Walking Tes

  Before and after the intervention: 5 weeks

Study Arms (3)

Observational learning from the therapist

EXPERIMENTAL

Patients with MCI (Mild Cognitive Impairment) will undergo intervention using therapist-led imitation exercises. They will engage in a 5-week exercise program based on observation and action. Data will be collected at the beginning and end of the program.

Other: Action observation training

peer learning

EXPERIMENTAL

Patients with MCI (Mild Cognitive Impairment) will undergo intervention using exercises by imitation from individuals residing in the facility but without cognitive impairment. They will participate in a 5-week exercise program based on observation and action. Data will be collected at the beginning and end of the program.

Other: Action observation training

control group

NO INTERVENTION

Patients with cognitive impairment who will receive the standard treatment provided by the facility.

Interventions

Action observation training OTHER

The activities proposed will be based on items from the FMA scale (Voluntary movement within synergies, voluntary movement mixing synergies, voluntary movement with little or no synergy, grip, coordination/speed, passive joint movement), and the exercises for the lower limbs will be designed by the authors of the study, based on Vivifrail (32), a multicomponent physical training program for the prevention of deconditioning and falls in older adults. These exercises will be progressive each week, focusing on strengthening, balance, and functional exercises to improve gait. The sessions will last between 20 and 30 minutes, with a frequency of three days per week. The intervention will last for 5 weeks.

Observational learning from the therapist; peer learning

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Residents or day care center users without visual or auditory impairments that cannot be corrected with the use of devices (such as glasses or hearing aids) and without any conditions affecting their upper limbs.
• Residents with mild cognitive impairment (MoCA score \<26) (23).
• Patients capable of walking at least 10 meters without severe pain in the lower limbs (according to the Visual Analog Scale).
• Patiens capable to perform the tests without the use of external aids or with the use of assistive devices such as a cane, and without medical contraindications for exercise.

You may not qualify if:

• The patients without cognitive impairment will be selected based on a MoCA score ranging from 26 to 30,
• Patients without any other neurological or musculoskeletal pathology.
• Patients with no upper limb disorders.
• Patients inability to complete the intervention full-time,
• Patients with presence of aggressive behavior or disturbances,
• Patients with inability to communicate verbally.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Cecilia Estrada Barranco

Villaviciosa de Odón, Madrid, 28670, Spain

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Cecilia Estrada Barranco, PhD

  Universidad Europea de Madrid

  STUDY DIRECTOR

Central Study Contacts

Cecilia Estrada Barranco, PhD

CONTACT

686166483; cecilia.estrada@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: July 6, 2023
• Study Start: April 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 20, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)