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Clinical Trials/NCT02769182
NCT02769182
Unknown
Not Applicable

Development and Validation of a Smart Phone Based System to Enhance Gait, Cognition and Socialization in Elderly Fallers

Tel-Aviv Sourasky Medical Center0 sites80 target enrollmentMay 2016
ConditionsOlder Adults

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Older Adults
Sponsor
Tel-Aviv Sourasky Medical Center
Enrollment
80
Primary Endpoint
Change in average number of steps per day
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
May 2019
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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) \<
  • 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.

Outcomes

Primary Outcomes

Change in average number of steps per day

Time Frame: Number of steps will be measured during one week after each assessment - at baseline, immediately after the training and 3 months after the training.

This will be evaluated by a small, lightweight waterproof accelerometer placed on the lower back of the participants (Axivity Ltd.)

Changes in the color Trails Making Test part B

Time Frame: At baseline, immediately after the training and 3 months after completing the training.

Secondary Outcomes

  • Changes in gait speed(At baseline, immediately after the training and 3 months after completing the training.)
  • Changes in fear of falling(At baseline, immediately after the training and 3 months after completing the training)
  • Changes in endurance(At baseline, immediately after the training and 3 months after completing the training)
  • Changes in social connectedness(At baseline, immediately after the training and 3 months after completing the training)
  • Changes in cognitive function: score in Frontal Assessment Battery(At baseline, immediately after the training and 3 months after completing the training)
  • Changes in functional mobility: dynamic gait index (DGI) score(At baseline, immediately after the training and 3 months after completing the training)
  • Changes in the Short Form Health Survey(At baseline, immediately after the training and 3 months after completing the training)
  • Changes in stride length(At baseline, immediately after the training and 3 months after completing the training.)
  • Changes in stride and swing time variability(At baseline, immediately after the training and 3 months after completing the training.)
  • Changes in cognitive function: number of digits(At baseline, immediately after the training and 3 months after completing the training)
  • Changes in cognitive function: number of correct / incorrect answers(At baseline, immediately after the training and 3 months after completing the training)
  • Changes in functional mobility: score in Four Square Step Test(At baseline, immediately after the training and 3 months after completing the training)

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