Use of a Smartphone to Assess Balance and Provide Intervention to Older Adults at Home

Study Overview
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Brief Summary
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Approximately one-third of older adults report one or more falls each year, with devastating physical, psychological, social, and financial consequences. Conventional gait analysis performed in a controlled laboratory environment can identify balance deficits, but unfortunately, such tools are bulky, time-consuming, and dependent on qualified technicians to properly collect and evaluate the data. Furthermore, these one-time gait and balance assessments cannot monitor changes in ambulatory strategies longitudinally and do not reflect performance in real-life environments, where falls commonly occur. While recent developments in smartphone-based evaluations have demonstrated great utility and accuracy in assessing gait performance, it is vital to evaluate participant compliance, ease-of-use, and feasibility of this technology using a smartphone in the home environment. It is also paramount that interventions which improve balance be accessible to older adults. While four-week balance training routines have been shown to improve balance performance among older adults, it is unknown whether such interventions can be conducted remotely in a safe and compliant manner. Furthermore, the retention of balance function following intervention is unclear. Subsequently, the goals of this study are to evaluate technology that can both remotely monitor balance and prescribe intervention to older adults. With the current burdens on the health care system and the burgeoning population of older adults, it is essential that tools be provided to older adults that are easy to follow, attractive, and improve balance performance. Therefore, the objective of this project is to investigate the utility of a valid, easily accessible, smartphone application to assess balance and provide personalized exercise for older adults as a stand-alone, field-based medical device. The aims of this proposal are to (1) utilize a smartphone application to longitudinally evaluate gait and standing balance over an 8-week period in the home environment among 30; and (2) determine the feasibility and efficacy of a smartphone application to promote exercise and evaluate gait changes for up to 2 months in this older adult population following a 4-week balance intervention. The long-term goal of this project is to provide a holistic home-based gait monitoring and intervention tool for integration in routine clinical care.

Official Title
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Longitudinal Home-based Evaluation of Balance and Exercise in Older Adults With and Without a History of Falls

Conditions
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Fall

Intervention / Treatment
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* Device: Balance Exercises - Smartphone Delivery
* Other: Balance Exercises - Traditional Paper Delivery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to ambulate at least 10 meters without an assistive device. Cognitively intact based on scoring 18/22 or greater on the Montreal Cognitive Assessment (MOCA) - Blind. Exclusion Criteria: Lower limb amputation Lower limb arthroplasty Visual impairment uncorrectable with lenses Uncontrolled hypertension or diabetes Neurological or musculoskeletal impairment Persistent symptoms of dizziness or lightheadedness

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Home - Paper Intervention<br>Older adults who are given a 4-week paper-based balance intervention program. Performed 3days/week for 30min/day over the course of a 4-week period using printed materials with text instruction and images. | Other: Balance Exercises - Traditional Paper Delivery<br>* 1st week: standing balance tasks; 2nd week: standing with arm manipulation tasks; 3rd week: gait balance tasks; 4th week: gait with arm manipulation tasks.<br>|
| Experimental: Home - Smartphone Intervention<br>Older adults who are given a 4-week home-based balance exercise program. Performed 3days/week for 30min/day over the course of a 4-week period using participants' smartphones. | Device: Balance Exercises - Smartphone Delivery<br>* 1st week: standing balance tasks; 2nd week: standing with arm manipulation tasks; 3rd week: gait balance tasks; 4th week: gait with arm manipulation tasks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual Task Gait Velocity | self-selected walking speed under dual task gait/cognitive conditions | Baseline | 
| Dual Task Gait Velocity | self-selected walking speed under dual task gait/cognitive conditions | One-month following baseline | 
| Dual Task Gait Velocity | self-selected walking speed under dual task gait/cognitive conditions | Two-months following baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual Task Verbal Reaction Time | Time taken to verbally respond to auditory stimulus under dual task gait/cognitive conditions | Baseline | 
| Dual Task Verbal Reaction Time | Time taken to verbally respond to auditory stimulus under dual task gait/cognitive conditions | One-month following baseline | 
| Dual Task Verbal Reaction Time | Time taken to verbally respond to auditory stimulus under dual task gait/cognitive conditions | Two-months following baseline | 
| Dual Task Standing Balance | Path of Center of Pressure (COP) during standing and performing secondary cognitive task | Baseline | 
| Dual Task Standing Balance | Path of COP during standing and performing secondary cognitive task | One-month following baseline | 
| Dual Task Standing Balance | Path of COP during standing and performing secondary cognitive task | Two-months following baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older Adults, Balance, Smartphone, Home-based Intervention