Clinical trial NCT05140044: Use of a Smartphone to Assess Balance and Provide Intervention to Older Adults at Home
Official title: Longitudinal Home-based Evaluation of Balance and Exercise in Older Adults With and Without a History of Falls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Keywords: Older Adults
Balance
Smartphone
Home-based Intervention
Lead sponsor: Binghamton University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 31
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Dual Task Gait Velocity
timeFrame: Baseline
measure: Dual Task Gait Velocity
timeFrame: One-month following baseline
measure: Dual Task Gait Velocity
timeFrame: Two-months following baseline
Secondary outcomes:
measure: Dual Task Verbal Reaction Time
timeFrame: Baseline
measure: Dual Task Verbal Reaction Time
timeFrame: One-month following baseline
measure: Dual Task Verbal Reaction Time
timeFrame: Two-months following baseline
measure: Dual Task Standing Balance
timeFrame: Baseline
measure: Dual Task Standing Balance
timeFrame: One-month following baseline
measure: Dual Task Standing Balance
timeFrame: Two-months following baseline
Other outcomes:
measure: Single Task Gait Velocity
timeFrame: Baseline
measure: Single Task Gait Velocity
timeFrame: One-month post baseline
measure: Single Task Gait Velocity
timeFrame: Two-months post baseline
measure: Singe Task Reaction Time
timeFrame: Baseline
measure: Singe Task Reaction Time
timeFrame: One-month post baseline
measure: Singe Task Reaction Time
timeFrame: Two-months post baseline
Locations:
city: Binghamton
country: United States
facility: Binghamton University - Motion Analysis Laboratory
state: New York
Study officials:
References: