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

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

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.

Study Overview

• Status: Completed
• Conditions: Fall
• Intervention / Treatment: Other: Balance Exercises - Traditional Paper Delivery; Device: Balance Exercises - Smartphone Delivery

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Binghamton, New York, United States, 13902
      • Binghamton University - Motion Analysis Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Home - Paper Intervention; 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; 1st week: standing balance tasks; 2nd week: standing with arm manipulation tasks; 3rd week: gait balance tasks; 4th week: gait with arm manipulation tasks.
Experimental: Home - Smartphone Intervention; 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; 1st week: standing balance tasks; 2nd week: standing with arm manipulation tasks; 3rd week: gait balance tasks; 4th week: gait with arm manipulation tasks.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single Task Gait Velocity	Level walking speed	Baseline
Single Task Gait Velocity	Level walking speed	One-month post baseline
Single Task Gait Velocity	Level walking speed	Two-months post baseline
Singe Task Reaction Time	Time taken to verbally respond to auditory stimulus while sitting	Baseline
Singe Task Reaction Time	Time taken to verbally respond to auditory stimulus while sitting	One-month post baseline
Singe Task Reaction Time	Time taken to verbally respond to auditory stimulus while sitting	Two-months post baseline

Collaborators and Investigators

• Sponsor: Binghamton University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Actual): April 24, 2023
• Study Completion (Actual): April 24, 2023

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Balance; Older Adults; Smartphone; Home-based Intervention
• Other Study ID Numbers: Smartphone Balance & Exercise

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) including demographic, gait, posture, and cognitive results as well as exercise conditions will be shared.
• IPD Sharing Time Frame: Starting 6 months after publication.
• IPD Sharing Access Criteria: IPD will be shared with other researchers on a case by case basis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No