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

T

Tel Aviv Sourasky Medical Center

Status

Unknown

Conditions

Older Adults

Treatments

Device: Monitoring and training using the system
Behavioral: Standard of care

Study type

Interventional

Funder types

Other

Identifiers

NCT02769182
TASMC-13-NG-127-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

65 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Monitoring and training using the system
Experimental group
Treatment:
Device: Monitoring and training using the system
Standard of care
Active Comparator group
Treatment:
Behavioral: Standard of care

Trial contacts and locations

0

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Central trial contact

Anat Mirelman, PhD; Moran Dorfman, MsPT

Data sourced from clinicaltrials.gov

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