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Non Verbal Communication and Dementia

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04255329
Acronym
GEMAN
Enrollment
0
Registered
2020-02-05
Start date
2020-02-29
Completion date
2021-09-27
Last updated
2021-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Neurocognitive Disorders

Keywords

Non pharmacological interventions, Cognitive stimulation, Non-verbal communication, Montessori Lifestyle

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.

Interventions

OTHERMontessori reading roundtable

Such book is written in a way to adaptate to people with cognitif and sensory impairments. Indeed, text is written in large characters and structured to not involve episodic memory. Each person read one page aloud in his turn. After the reading phase, the participants discuss the questions about their opinions and distant memories.

OTHERUsual reading

The readen text is a normal, currently used in a everyday life support such as a journal article.

Sponsors

University of Geneva, Switzerland
CollaboratorOTHER
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
gestuality frequency18 monthsfrequency 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 duration18 monthsduration 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

MeasureTime frameDescription
Participants satisfaction18 monthssatisfaction self reported by participants by circle one of the tree smiley (sad ; neutral; happy)
score in Observed Emotions Scale18 monthsDuration of signs of pleasure, anger, anxiety/fear, sadness and general alertness over en ten-imunt observation period in a 6 item scale : not in view ; never ; less than 16 sec. ; 16-59 sec. ; 1-5 min. ; more than 5 min. (Lawton, M.P., Van Haitsma, K. & Klapper, J.A (1999).
Score in Cornell depression Scale18 monthsscore from 0 to 38, higher score indicated higher risks of depression syndrom. (1988)
Score in NeuroPsychiatric Inventory18 monthsscore from 0 to 144, higher score indicated higher challenging behaviors (Sisco, F. et al., 2000).
Score in Menorah Park Engagement Scale18 monthsreported participants engagement thanks to a 6 questions questionnaire : did the participant take part in the activity (yes/no) ; how long did the participant realise or comment the activity, listen/look the activity, do other things, sleep/keep eyes closed, expresse pleasure (not at all ; less than half of the time ; more than half of the time) (Camp, 2004)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026