Effect of Remote Cognitive Intervention… | Clinical Trial

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases COVID-19 Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Mild Cognitive Impairment Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nidovirales Infections Parkinsonian Disorders Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Synucleinopathies Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS INRCA Hospital

Ancona, 60127, Italy

About this study

Mild cognitive impairment is frequent among people with Parkinson's disease. Cognitive training seems effective on cognitive status and for mitigating anxiety and depression. With COVID-19 outbreak, such therapeutic interventions were delivered online. This retrospective study was aimed at evaluating the effectiveness of an online cognitive treatment, carried out in COVID times and based on the Parkinson's-Adapted Cognitive Stimulation Therapy, on cognitive domains and mood in 18 older people with Parkinson's disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Parkinson disease: Hoehn & Yahr's scale: 1-3 based on the UK PD Society Brain Bank
mild cognitive impairment
no cognitive training between March and October 2020
presence of a family caregiver to access and use the online platform

Exclusion criteria

other neurological diseases
deep brain stimulation
schizophrenia
depression
sensory deprivations that could interfere with the treatment

Treatment and study plan

Cognitive digital treatment

Other

The remote cognitive-rehabilitation treatment was based on Parkinson's adapted cognitive stimulation therapy (CST). Fourteen twice-weekly sessions were planned, followed by one session per week for a duration of six months for maintenance therapy. The treatment took place in groups of 4 patients in remote mode through the Microsoft-Teams platform. All subjects maintained the prescribed drug therapy and regular physiotherapy activity during the intervention.

Primary outcomes

changes in cognitive status

Time frame: This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)

The Mini Mental State Examination (MMSE) was used to evaluate the cognitive status.The test consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, sriting ability and reproduction of complex polygons); the total score can range from 0 to 30, with a higher score indicating better function.

Secondary outcomes

changes in cognitive domains

Time frame: This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)

The Addembrooke's Cognitive Examination Battery (ACE-R) was used to evaluate the cognitive domains. The ACE-R consists of six components evaluating separate cognitive domains. A maximum score of 100 is weighted as follows: orientation (10), attention (8), memory(35), verbal fluency (14), language (28), and visuospatialability (5).
changes in thymic state

Time frame: This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)

The Geriatric Depression Scale-15 items (GDS-15 items) was used to evaluate the tymic state.This instrument evaluated depressive symptoms using yes/no answers. Scores range between 0 and 15 points. Higher scores indicate more severe depressive symptoms.

Sponsors and collaborators

Lead sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Other

Registry information

Acronym: TELEPARK

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jul 27, 2022
Registry last updated: Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed