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Non Verbal Communication and Dementia (GEMAN)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Withdrawn

Conditions

Alzheimer Disease
Neurocognitive Disorders

Treatments

Other: Montessori reading roundtable
Other: Usual reading

Study type

Interventional

Funder types

Other

Identifiers

NCT04255329
RECHMPL18_0071

Details and patient eligibility

About

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.

Sex

All

Ages

65 to 100 years old

Volunteers

No Healthy Volunteers

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
  • If the patient or guardian cannot be given informed information

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Usual reading group
Other group
Description:
The leader of the activity reads aloud a text to four participants seated around the table. The readen text is a normal, currently used in a everyday life support such as a journal article. Consequently it is not previously adaptated to people with cognitive impairements. After the reading phase, the leader asks the participants the questions about the content.
Treatment:
Other: Usual reading
Montessori reading roundtable group
Other group
Description:
The group counts four participants and one activity leader. Each person have the same Montessori reading roundtable book.
Treatment:
Other: Montessori reading roundtable

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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