- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02769182
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
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
80
Phase
- 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
- Name: Anat Mirelman, PhD
- Phone Number: 972-36974957
- Email: anatmi@tlvmc.gov.il
Study Contact Backup
- Name: Moran Dorfman, MsPT
- Phone Number: 972-36974957
- Email: morando@tlvmc.gov.il
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
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 |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
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
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
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
Collaborators
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
May 1, 2016
Primary Completion (Anticipated)
May 1, 2019
Study Registration Dates
First Submitted
May 2, 2016
First Submitted That Met QC Criteria
May 8, 2016
First Posted (Estimate)
May 11, 2016
Study Record Updates
Last Update Posted (Estimate)
May 11, 2016
Last Update Submitted That Met QC Criteria
May 8, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID 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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