Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 6677 for:    senior citizens

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02769182
Recruitment Status : Unknown
Verified May 2016 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 11, 2016
Last Update Posted : May 11, 2016
Sponsor:
Collaborator:
HIT Holon Institute of Technology
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment Phase
Older Adults Device: Monitoring and training using the system Behavioral: Standard of care Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Development and Validation of a Smart Phone Based System to Enhance Gait, Cognition and Socialization in Elderly Fallers
Study Start Date : May 2016
Estimated Primary Completion Date : May 2019

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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.)

  2. 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 Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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

  5. 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.

  6. 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

  7. 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.

  8. 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

  9. 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

  10. 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.

  11. 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

  12. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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) <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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769182


Contacts
Layout table for location contacts
Contact: Anat Mirelman, PhD 972-36974957 anatmi@tlvmc.gov.il
Contact: Moran Dorfman, MsPT 972-36974957 morando@tlvmc.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
HIT Holon Institute of Technology

Layout table for additonal information
Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02769182     History of Changes
Other Study ID Numbers: TASMC-13-NG-127-CTIL
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tel-Aviv Sourasky Medical Center:
Older adults
falls
cognition
smart phone