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

NCT02769182 | Unknown

• 1 other identifier: TASMC-13-NG-127-CTIL
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Older Adults

Keywords

Older adults; falls; cognition; smart phone

Outcome Measures

Primary Outcomes (2)

• 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.)

  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

  At baseline, immediately after the training and 3 months after completing the training.

Secondary Outcomes (12)

• Changes in gait speed

  At baseline, immediately after the training and 3 months after completing the training.

• Changes in fear of falling

  At baseline, immediately after the training and 3 months after completing the training

• Changes in endurance

  At baseline, immediately after the training and 3 months after completing the training

• Changes in social connectedness

  At baseline, immediately after the training and 3 months after completing the training

• Changes in cognitive function: score in Frontal Assessment Battery

  At baseline, immediately after the training and 3 months after completing the training

Study Arms (2)

Monitoring and training using the system

EXPERIMENTAL

Device: Monitoring and training using the system

Standard of care

ACTIVE COMPARATOR

Behavioral: Standard of care

Interventions

Monitoring and training using the system DEVICE

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.

Monitoring and training using the system

Standard of care BEHAVIORAL

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.

Standard of care

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Ages of 65-85 years
• History of 1 fall or more in the year prior to the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• HIT Holon Institute of Technology: collaborator

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Anat Mirelman, PhD

CONTACT

972-36974957; anatmi@tlvmc.gov.il

Moran Dorfman, MsPT

CONTACT

972-36974957; morando@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 11, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2019
• Last Updated: May 11, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share