Skip to main content
OpenTrials
Completed

NCT Number: NCT05140044

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Binghamton University - Motion Analysis Laboratory

Binghamton, New York, 13902, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Balance Exercises - Smartphone Delivery

Device

1st week: standing balance tasks; 2nd week: standing with arm manipulation tasks; 3rd week: gait balance tasks; 4th week: gait with arm manipulation tasks.

Balance Exercises - Traditional Paper Delivery

Other

1st week: standing balance tasks; 2nd week: standing with arm manipulation tasks; 3rd week: gait balance tasks; 4th week: gait with arm manipulation tasks.

Primary outcomes

  1. Dual Task Gait Velocity

    Time frame: Baseline

    self-selected walking speed under dual task gait/cognitive conditions

  2. Dual Task Gait Velocity

    Time frame: One-month following baseline

    self-selected walking speed under dual task gait/cognitive conditions

  3. Dual Task Gait Velocity

    Time frame: Two-months following baseline

    self-selected walking speed under dual task gait/cognitive conditions

Secondary outcomes

  1. Dual Task Verbal Reaction Time

    Time frame: Baseline

    Time taken to verbally respond to auditory stimulus under dual task gait/cognitive conditions

  2. Dual Task Verbal Reaction Time

    Time frame: One-month following baseline

    Time taken to verbally respond to auditory stimulus under dual task gait/cognitive conditions

  3. Dual Task Verbal Reaction Time

    Time frame: Two-months following baseline

    Time taken to verbally respond to auditory stimulus under dual task gait/cognitive conditions

  4. Dual Task Standing Balance

    Time frame: Baseline

    Path of Center of Pressure (COP) during standing and performing secondary cognitive task

  5. Dual Task Standing Balance

    Time frame: One-month following baseline

    Path of COP during standing and performing secondary cognitive task

  6. Dual Task Standing Balance

    Time frame: Two-months following baseline

    Path of COP during standing and performing secondary cognitive task

Other outcomes

  1. Single Task Gait Velocity

    Time frame: Baseline

    Level walking speed

  2. Single Task Gait Velocity

    Time frame: One-month post baseline

    Level walking speed

  3. Single Task Gait Velocity

    Time frame: Two-months post baseline

    Level walking speed

  4. Singe Task Reaction Time

    Time frame: Baseline

    Time taken to verbally respond to auditory stimulus while sitting

  5. Singe Task Reaction Time

    Time frame: One-month post baseline

    Time taken to verbally respond to auditory stimulus while sitting

  6. Singe Task Reaction Time

    Time frame: Two-months post baseline

    Time taken to verbally respond to auditory stimulus while sitting

Sponsors and collaborators

Lead sponsor

Binghamton University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2021
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.