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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05140044
Other study ID # Smartphone Balance & Exercise
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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