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Clinical Trials/NCT04255329
NCT04255329
Withdrawn
Not Applicable

Comparative Study of Two Cognitive Stimulation Approaches Using the Non-verbal Communication on People With Alzheimer's Disease and/or Related Diseases at a Moderate to Advanced Stage of Evolution

University Hospital, Montpellier1 site in 1 countryFebruary 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurocognitive Disorders
Sponsor
University Hospital, Montpellier
Locations
1
Primary Endpoint
gestuality frequency
Status
Withdrawn
Last Updated
4 years ago

Overview

Brief Summary

Cognitive impairements in Alzheimer's and apparented disorders may lead to the decreased engagement in activities, spetially in moderate and advanced stages of evolution. The lack of stimulation for people with dementia is associated with the risk of challenging behaviors, depressives symptoms, sleeping disorders or faster cognitive deterioration. Those challenges may lead to the increased administration of pharmacological treatments, though the risks of neurleptics use in this population are currently known. In this context, non-pharacological interventions hold a significant place in dementia care.

This research focuses on cognitve stimulation activities. More precisly, our study compares two aproaches using the reading groups. The first type (" usual " reading group) is based on the principle of stimulating those cognitive functions which dicreases with the evolution of dementia. The second (Montessori reading group) approach relies on the idea to use preserved capacities in order to compensate the cognitive impariments.

The aim of our study is to compare the impact of these two non-pharmalogical interventions on non-verbal communication. The collected datas will help analyzing and understanding the internal and behavioral states of people living with dementia. Our study will also extend relfexions about cognitive stimulation groups in care institutions.

Registry
clinicaltrials.gov
Start Date
February 2020
End Date
September 27, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 65 years and more
  • Diagnosed with Alzheimer's disease and/or related disease (frontotemporal dementia, vascular dementia, multiple etiologies dementia, Lewy's Body dementia) according to DSM-IV-TR criteria (2005)
  • MMSE ≤ 15
  • Good reading ability assessed using Montessori Reading Test (ability to read text written in Arial 40)
  • The written agreement of the patient, primary caregiver or curator or or guardian to participate in the study and to make a film about the participant.
  • Patient receiving social security benefits

Exclusion Criteria

  • Previously known associated psychotic disorder
  • Deafness not compensated by hearing aid
  • Extrapyramidal syndrome diagnosed by a practitioner
  • Tendency to daytime sleepiness (Score 6 on the Karolinska somnolence scale)
  • Patient with disruptive behaviour disorders such as screaming and/or motor agitation likely to affect the smooth running of the workshop
  • Subject deprived of liberty by judicial or administrative decision.
  • Subject under exclusion for another research protocol.
  • Presence of motor stereotypes
  • Patient receiving State Medical Assistance (AME)
  • Patient under Justice Safeguard

Outcomes

Primary Outcomes

gestuality frequency

Time Frame: 18 months

frequency of gestures (number of gestures observed) unrelated with the activity (item manipulations unrelated with the activity, comfort posture, self-focus gestures, look outside the interaction space) measured by ANVIL software.

gestuality duration

Time Frame: 18 months

duration of gestures (duration of gestures observed in seconds) unrelated with the activity (item manipulations unrelated with the activity, comfort posture, self-focus gestures, look outside the interaction space) measured by ANVIL

Secondary Outcomes

  • Score in NeuroPsychiatric Inventory(18 months)
  • Score in Menorah Park Engagement Scale(18 months)
  • score in Observed Emotions Scale(18 months)
  • Participants satisfaction(18 months)
  • Score in Cornell depression Scale(18 months)

Study Sites (1)

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