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

May 8, 2016 updated by: Tel-Aviv Sourasky Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard of care
Behavioral: Standard of care
Subjects in this group will not receive the system but will encouraged to continue with their daily living routine and provided with recommendations for stretching and strengthening exercises. The control group subjects will be assessed at the same three time points as those in the experimental group. Subjects in both groups will also receive written information about the importance of activity, cognitive enhancing tasks, avoidance of falls and home hazards. In Israel, this information combined with an exercise prescription is considered the 'standard of care' for community-dwelling older adults.
Experimental: Monitoring and training using the system
Device: Monitoring and training using the system
subjects and caregivers will be trained on using the system and receive a 'user manual' delineating all procedures and possible applications of the system, as well as operations for daily charging of the sensors and smart phone. They will then be fitted with the sensors. The clinician will set all necessary applications, including setting the cognitive games application and the 'network of users'. Users and care givers will be informed of the personalized recommendations system that will provide the user with daily feedback on activity and weekly recommendations and goals for duration of the study. A helpline will be provided in case technological problems occur or for routine support.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.)
Number of steps will be measured during one week after each assessment - at baseline, immediately after the training and 3 months after the training.
Changes in the color Trails Making Test part B
Time Frame: At baseline, immediately after the training and 3 months after completing the training.
At baseline, immediately after the training and 3 months after completing the training.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in gait speed
Time Frame: At baseline, immediately after the training and 3 months after completing the training.
gait speed will be evaluated under two conditions each over 1 minute: i) walking at comfortable speed, ii) walking while performing a cognitive task (dual task).
At baseline, immediately after the training and 3 months after completing the training.
Changes in fear of falling
Time Frame: At baseline, immediately after the training and 3 months after completing the training
falls Efficacy Scale International (FES-I).
At baseline, immediately after the training and 3 months after completing the training
Changes in endurance
Time Frame: At baseline, immediately after the training and 3 months after completing the training
Total distance walked in six minutes (6MWT).
At baseline, immediately after the training and 3 months after completing the training
Changes in social connectedness
Time Frame: At baseline, immediately after the training and 3 months after completing the training
Social engagement: the Berkman-Syme Social Network Index
At baseline, immediately after the training and 3 months after completing the training
Changes in cognitive function: score in Frontal Assessment Battery
Time Frame: At baseline, immediately after the training and 3 months after completing the training
Frontal Assessment Battery: this battery is sensitive to frontal lobe dysfunction consists of six subtests exploring the following: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. It takes approximately 10 minutes to administer.
At baseline, immediately after the training and 3 months after completing the training
Changes in functional mobility: dynamic gait index (DGI) score
Time Frame: At baseline, immediately after the training and 3 months after completing the training
DGI is a clinical tool to assess gait, balance and fall risk. It evaluates not only usual steady-state walking, but also walking during more challenging tasks
At baseline, immediately after the training and 3 months after completing the training
Changes in the Short Form Health Survey
Time Frame: At baseline, immediately after the training and 3 months after completing the training
The Short Form Health Survey to evaluate different dimensions of health related quality of life including mobility, emotional well-being, and cognitive impairment.
At baseline, immediately after the training and 3 months after completing the training
Changes in stride length
Time Frame: At baseline, immediately after the training and 3 months after completing the training.
Stride length will be evaluated under two conditions each over 1 minute: i) walking at
At baseline, immediately after the training and 3 months after completing the training.
Changes in stride and swing time variability
Time Frame: At baseline, immediately after the training and 3 months after completing the training.
Stride and swing time variability will be evaluated under two conditions each over 1 minute: i) walking at
At baseline, immediately after the training and 3 months after completing the training.
Changes in cognitive function: number of digits
Time Frame: At baseline, immediately after the training and 3 months after completing the training
Working memory (forward and backward digit span): Forward and backward digit span is a common measure of short-term memory (working memory). It is also a component of cognitive ability tests. Backward memory span is a more challenging variation which involves recalling items in reverse order.
At baseline, immediately after the training and 3 months after completing the training
Changes in cognitive function: number of correct / incorrect answers
Time Frame: At baseline, immediately after the training and 3 months after completing the training
Dual tasking (DT) walking performance: alternation in the ability to walk while simultaneously performing another task, have been related to gait and balance impairment. The negative effects of DT have been associated with an increased risk of falling, underscoring the clinical importance of DT abilities
At baseline, immediately after the training and 3 months after completing the training
Changes in functional mobility: score in Four Square Step Test
Time Frame: At baseline, immediately after the training and 3 months after completing the training
Four Square Step Test is a dynamic balance test that clinically assesses the person's ability to step over objects forward, sideways, and backwards
At baseline, immediately after the training and 3 months after completing the training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tel-Aviv Sourasky Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
HIT Holon Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TASMC-13-NG-127-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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