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

Fall Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05140044
• Other study ID #: Smartphone Balance & Exercise
• Status: Completed
• Phase: N/A
• Start date: October 13, 2022
• Est. completion date: April 24, 2023

Study information

• Verified date: June 2023
• Source: Binghamton University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 24, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Fall

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Binghamton University - Motion Analysis Laboratory	Binghamton	New York

Sponsors (1)

Lead Sponsor	Collaborator
Binghamton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Single Task Gait Velocity	Level walking speed	Baseline
Other	Single Task Gait Velocity	Level walking speed	One-month post baseline
Other	Single Task Gait Velocity	Level walking speed	Two-months post baseline
Other	Singe Task Reaction Time	Time taken to verbally respond to auditory stimulus while sitting	Baseline
Other	Singe Task Reaction Time	Time taken to verbally respond to auditory stimulus while sitting	One-month post baseline
Other	Singe Task Reaction Time	Time taken to verbally respond to auditory stimulus while sitting	Two-months post baseline
Primary	Dual Task Gait Velocity	self-selected walking speed under dual task gait/cognitive conditions	Baseline
Primary	Dual Task Gait Velocity	self-selected walking speed under dual task gait/cognitive conditions	One-month following baseline
Primary	Dual Task Gait Velocity	self-selected walking speed under dual task gait/cognitive conditions	Two-months following baseline
Secondary	Dual Task Verbal Reaction Time	Time taken to verbally respond to auditory stimulus under dual task gait/cognitive conditions	Baseline
Secondary	Dual Task Verbal Reaction Time	Time taken to verbally respond to auditory stimulus under dual task gait/cognitive conditions	One-month following baseline
Secondary	Dual Task Verbal Reaction Time	Time taken to verbally respond to auditory stimulus under dual task gait/cognitive conditions	Two-months following baseline
Secondary	Dual Task Standing Balance	Path of Center of Pressure (COP) during standing and performing secondary cognitive task	Baseline
Secondary	Dual Task Standing Balance	Path of COP during standing and performing secondary cognitive task	One-month following baseline
Secondary	Dual Task Standing Balance	Path of COP during standing and performing secondary cognitive task	Two-months following baseline