Clinical trial NCT02769182: Development and Validation of a Smart Phone Based System to Enhance Gait, Cognition and Socialization in Elderly Fallers
Official title: Development and Validation of a Smart Phone Based System to Enhance Gait, Cognition and Socialization in Elderly Fallers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Older Adults
Keywords: Older adults
falls
cognition
smart phone
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: HIT Holon Institute of Technology
First posted: 2016-05-11
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this research is to develop and validate a technology-based solution that addresses the diminished mobility, increased fall risk and impaired cognitive function that are so common among older adults, enabling them to live longer successfully and independently.

Detailed description: A comprehensive system will be developed to promote mobility, enhance cognitive function, reduce sedentary behavior, increase independence and encourage social inclusion. This novel system will have two distinct yet complementary features: monitoring and treatment that will serve as an "all in one system". The system will consist of wearable sensors and a proprietary developed application. The wearable inertial sensors will measure the acceleration and orientation of the feet during movement. The sensors will feed real-time data to the system, which will process this data using a set of proprietary algorithms enabling continuous monitoring of activity, gait and fall risk, and independence. In addition, designated applications for direct cognitive assessment and training of older adults in their home and community environment will also be used via the Smart phone or mobile tablet. The training, both physical and cognitive, will also include multi-user interactions .Data collected by the system will be processed and integrated to provide comprehensive feedback from multiple domains to the user, caregiver and clinician by way of recommendations and personalized treatment goals.

Eligibility criteria: Inclusion Criteria:

* Ages of 65-85 years
* History of 1 fall or more in the year prior to the study.

Exclusion Criteria:

* Signs of dementia : Montreal Cognitive Assessment (MoCa) \<21 and/or mini mental state examination(MMSE) \<24.
* Psychiatric co-morbidities :major depression as determined by Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria
* Co-existing somatic disorders
* History of stroke
* Neurologic disorders that interferes with normal walking (e.g., Parkinson's disease or Alzheimer's disease),
* Cannot walk without assistance,
* Severe head trauma or brain tumor,
* Severe hearing or visual loss (determined by the visual acuity test),
* Cardio-vascular contradictions (as determined by a physician),
* Inability to use a Smart phone because of visual and manual impairment or have unstable medical conditions.

Primary outcomes:
measure: Change in average number of steps per day
timeFrame: Number of steps will be measured during one week after each assessment - at baseline, immediately after the training and 3 months after the training.
measure: Changes in the color Trails Making Test part B
timeFrame: At baseline, immediately after the training and 3 months after completing the training.
Secondary outcomes:
measure: Changes in gait speed
timeFrame: At baseline, immediately after the training and 3 months after completing the training.
measure: Changes in fear of falling
timeFrame: At baseline, immediately after the training and 3 months after completing the training
measure: Changes in endurance
timeFrame: At baseline, immediately after the training and 3 months after completing the training
measure: Changes in social connectedness
timeFrame: At baseline, immediately after the training and 3 months after completing the training
measure: Changes in cognitive function: score in Frontal Assessment Battery
timeFrame: At baseline, immediately after the training and 3 months after completing the training
measure: Changes in functional mobility: dynamic gait index (DGI) score
timeFrame: At baseline, immediately after the training and 3 months after completing the training
measure: Changes in the Short Form Health Survey
timeFrame: At baseline, immediately after the training and 3 months after completing the training
measure: Changes in stride length
timeFrame: At baseline, immediately after the training and 3 months after completing the training.
measure: Changes in stride and swing time variability
timeFrame: At baseline, immediately after the training and 3 months after completing the training.
measure: Changes in cognitive function: number of digits
timeFrame: At baseline, immediately after the training and 3 months after completing the training
measure: Changes in cognitive function: number of correct / incorrect answers
timeFrame: At baseline, immediately after the training and 3 months after completing the training
measure: Changes in functional mobility: score in Four Square Step Test
timeFrame: At baseline, immediately after the training and 3 months after completing the training
Other outcomes:
Locations:
Study officials:
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