Sensor-based systems for early detection of dementia

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00013167
• Date of registration: 11/04/2018
• Prospective Registration: No
• Primary sponsor: TU Chemnitz, Human- und Sozialwissenschaftliche Fakultät, Institut für Angewandte Bewegungswissenschaften, Professur Sportpsychologie (mit Schwerpunkt Prävention und Rehabilitation)
• Public title: Sensor-based systems for early detection of dementia
• Scientific title: Sensor-based systems for early detection of dementia - SENDA
• Date of first enrolment: 01/02/2018
• Target sample size: 240
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00013167
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: diagnostic

Countries of recruitment

Germany

Contacts

• Name: Katrin Müller
• Affiliation: Technische Universität Chemnitz, Fakultät für Human- und Sozialwissenschaften, Institut für Angewandte Bewegungswissenschaften, Professur Sportpsychologie (mit Schwerpunkt Prävention und Rehabilitation)

• Name: Claudia Voelcker-Rehage
• Affiliation: Technische Universität Chemnitz, Fakultät für Human- und Sozialwissenschaften, Institut für Angewandte Bewegungswissenschaften, Professur Sportpsychologie (mit Schwerpunkt Prävention und Rehabilitation)

Key inclusion & exclusion criteria

Inclusion criteria: - Informed consent for study participation,
- Basics skills in German language,
- Study participant can independently or with the help of an accompanying person visit assessments,
- Study participant can walk independently (a walking aid or a rolling walking is aloud)

Exclusion criteria: - Medically prohibited to be physically active,
- Diagnosed psychological disorders as major depression or neurocognitive disorders as dementia
- Permanent impairments due to a stroke or a brain surgery,
- Other neurological diseases as epilepsy, Parkinson, neuropathy
- Severe diseases of the cardiovascular system (e.g., cardiac arrhythmia, arterial occlusive disease, heart failure)
- Severe diseases of respiratory system (e.g., COPD stage 4, severe asthma)
- Severe diseases of the musculoskeletal system (e.g. arthritis, orthopedic operations in the last 6 months)
- Diabetes with diagnosed neuropathy
- Substance abuse (delirium)
- Difficulties in understanding language or speech
- Participant of other clinical studies e.g. for clinical testing of new anti-dementia drugs


Age minimum: 80 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

F06.7

older healthy people, Mild Cognitive Impairment (MCI)
F06.7

Mild cognitive disorder

Intervention(s)

Group 1: At the beginning of the study participants will be divided into three groups depending on their cognitive status: 1. cognitive healthy participants, 2. subjectively cognitive impaired participants, 3. participants with mild cognitive impairment.
All measurements will be assessed four times within three years in intervals of eight months to identify associations to cognitive changes over time.
One time of measurement consists of 3 examination days. The same motor, sensory, neurophysiological, and cognitive measurements will be conducted for each time of measurement.

Primary Outcome(s)

The primary endpoint is to identify motor, sensory, neurophysiological and cognitive parameters to predict cognitive decline or dementia in older people.

All measurements will be assessed four times within three years in intervals of eight months to identify associations to cognitive changes over time. One time of measurement consists of 3 examination days. The same motor, sensory, neurophysiological, and cognitive measurements will be conducted for each time of measurement.

Measurements, questionnaires:
- Montreal Cognitive Assessment,
- Consortium to Establish a Registry for Alzheimer`s Disease,
- Questionnaire for subjective assessment of mental performance,
- Digit Symbol Substitution Test,
- gait analysis with OptoGait(R) under single- and dual-task conditions using 3D cameras for video recordings,
- Short physical performance battery,
- hand force dynamometer,
- EEG measurements,
- Eriksen flanker task,
- fine motor measurements e.g. spontaneous finger tapping, force tracking task, foot coordination,
- sensory measurements with shaker or mini-shaker,
- Limits of Stability Test, balance tests on the posturomed under single-task and dual-task conditions

Secondary Outcome(s)

All measurements will be assessed four times within three years in intervals of eight months to identify associations to cognitive changes over time. One time of measurement consists of 3 examination days. The additional measurements will be conducted for each time of measurement. Therefor, functional, cognitive as well as mental health and lifestyle factors, that might be associated with cognitive decline, will be assessed. These include frailty, comorbidities, social support, quality of life, physical activity, depressive symptoms, and fear of falling.

Questionnaires:
- Big Five Inventory,
- Geriatric depression scale,
- Charlson Comorbidity Index,
- Questionnaire for social support,
- BAECKE inventory for physical activity,
- PRISCUS PAQ,
- NAI,
- FRAIL scale,
- Tilburg Frailty Indicator

Source(s) of Monetary Support

Europäischer Sozialfond und der Freistaat Sachsen, Sächsische AufbauBank-Förderbank (SAB)

Ethics review

Status: Approved
Approval date: 19/12/2017
Contact:

Ethikkommission der Fakultät für Human- und Sozialwissenschaften [Ethikkommission der Fakultät Human- und Sozialwissenschaften der Technischen Universität Chemnitz, 09107 Chemnitz, Deutschland]

Results

• URL: http://drks.de/search/en/trial/DRKS00013167#studyResults