Older AdultsNCT02769182
Development and Validation of a Smart Phone Based System to Enhance Gait, Cognition and Socialization in Elderly Fallers
A study testing Monitoring and training using the system in people with Older Adults, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- Monitoring and training using the system
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Ages of 65-85 years
- History of 1 fall or more in the year prior to the study.
Who cannot join
- 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,
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- 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 locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Older Adults
- Being tested
- Monitoring and training using the system, Standard of care
- Keywords
- Older adults, falls, cognition, smart phone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring and training using the systemDevice
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.
Standard of careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Monitoring and training using the system | Experimental | Not described Receives: Device: Monitoring and training using the system |
| Standard of care | Active comparator | Not described Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average number of steps per day
This will be evaluated by a small, lightweight waterproof accelerometer placed on the lower back of the participants (Axivity Ltd.)
Measured: 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
Measured: At baseline, immediately after the training and 3 months after completing the training.
Secondary outcomes (12)
Changes in gait speed
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).
Measured: At baseline, immediately after the training and 3 months after completing the training.
Changes in fear of falling
falls Efficacy Scale International (FES-I).
Measured: At baseline, immediately after the training and 3 months after completing the training
Changes in endurance
Total distance walked in six minutes (6MWT).
Measured: At baseline, immediately after the training and 3 months after completing the training
Changes in social connectedness
Social engagement: the Berkman-Syme Social Network Index
Measured: At baseline, immediately after the training and 3 months after completing the training
Changes in cognitive function: score in Frontal Assessment Battery
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.
Measured: At baseline, immediately after the training and 3 months after completing the training
Changes in functional mobility: dynamic gait index (DGI) score
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
Measured: At baseline, immediately after the training and 3 months after completing the training
Changes in the Short Form Health Survey
The Short Form Health Survey to evaluate different dimensions of health related quality of life including mobility, emotional well-being, and cognitive impairment.
Measured: At baseline, immediately after the training and 3 months after completing the training
Changes in stride length
Stride length will be evaluated under two conditions each over 1 minute: i) walking at
Measured: At baseline, immediately after the training and 3 months after completing the training.
Changes in stride and swing time variability
Stride and swing time variability will be evaluated under two conditions each over 1 minute: i) walking at
Measured: At baseline, immediately after the training and 3 months after completing the training.
Changes in cognitive function: number of digits
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.
Measured: At baseline, immediately after the training and 3 months after completing the training
Changes in cognitive function: number of correct / incorrect answers
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
Measured: At baseline, immediately after the training and 3 months after completing the training
Changes in functional mobility: score in Four Square Step Test
Four Square Step Test is a dynamic balance test that clinically assesses the person's ability to step over objects forward, sideways, and backwards
Measured: At baseline, immediately after the training and 3 months after completing the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- HIT Holon Institute of Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769182
- Sponsor's protocol ID
- TASMC-13-NG-127-CTIL
- Status last verified
- May 2016
- First submitted
- 2 May 2016
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Smart Phone Based System to Enhance Gait, Cognition and Socialization in Elderly Fallers
- ClinicalTrials.gov ID
- NCT02769182
- Acronym / sponsor ID
- TASMC-13-NG-127-CTIL
- Conditions
- Older Adults
- Keywords
- Older adults, falls, cognition, smart phone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- HIT Holon Institute of Technology
- Study start
- May 2016
- Primary completion
- May 2019 (estimated)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring and training using the system | Experimental | Device: Monitoring and training using the system |
| Standard of care | Active comparator | Behavioral: Standard of care |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Ages of 65-85 years
- History of 1 fall or more in the year prior to the study.
Key exclusion criteria (10 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring and training using the systemsubjects 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. | Device | Monitoring and training using the system |
| Standard of careSubjects 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. | Behavioural | Standard of care |
Primary outcome
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.
12 secondary outcomes
Changes in gait speed
Time frame: 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
Changes in endurance
Time frame: 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
Changes in cognitive function: score in Frontal Assessment Battery
Time frame: 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
Changes in the Short Form Health Survey
Time frame: 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.
Changes in stride and swing time variability
Time frame: 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
Changes in cognitive function: number of correct / incorrect answers
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring and training using the system in people with Older Adults, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anat Mirelman, PhD (972-36974957, anatmi@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.