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

NCT ID: NCT05140044

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-13
• Study Completion Date: 2023-04-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Balance Exercises - Traditional Paper Delivery

Intervention Type: 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 - 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.

Group Type: EXPERIMENTAL

Balance Exercises - Smartphone Delivery

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Binghamton University

OTHER

Sponsor Role: lead

Responsible Party

Vipul Lugade

Associate Professor and Director of Motion Analysis Research Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Binghamton University - Motion Analysis Laboratory

Binghamton, New York, United States

Countries

United States

Other Identifiers

Smartphone Balance & Exercise

Identifier Type: -

Identifier Source: org_study_id