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

NCT05140044 | Completed

• 1 other identifier: Smartphone Balance & Exercise
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall

Keywords

Older Adults; Balance; Smartphone; Home-based Intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Dual Task Verbal Reaction Time

  Baseline

• Dual Task Verbal Reaction Time

  One-month following baseline

• Dual Task Verbal Reaction Time

  Two-months following baseline

• Dual Task Standing Balance

  Baseline

• Dual Task Standing Balance

  One-month following baseline

Other Outcomes (6)

• Single Task Gait Velocity

  Baseline

• Single Task Gait Velocity

  One-month post baseline

• Single Task Gait Velocity

  Two-months post baseline

Study Arms (2)

Home - Paper Intervention

ACTIVE COMPARATOR

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

Home - Smartphone Intervention

EXPERIMENTAL

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

Interventions

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.

Home - Smartphone Intervention

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.

Home - Paper Intervention

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Binghamton University: lead

Study Sites (1)

Binghamton University - Motion Analysis Laboratory

Binghamton, New York, 13902, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Director of Motion Analysis Research Laboratory

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 1, 2021
• Study Start: October 13, 2022
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication.
• Access Criteria: IPD will be shared with other researchers on a case by case basis.

Locations

US (1)