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Clinical Trials/NCT05140044
NCT05140044
Completed
Not Applicable

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

Binghamton University1 site in 1 country31 target enrollmentOctober 13, 2022
ConditionsFall

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fall
Sponsor
Binghamton University
Enrollment
31
Locations
1
Primary Endpoint
Dual Task Gait Velocity
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 13, 2022
End Date
April 24, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vipul Lugade

Associate Professor and Director of Motion Analysis Research Laboratory

Binghamton University

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

Outcomes

Primary Outcomes

Dual Task Gait Velocity

Time Frame: Two-months following baseline

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

Secondary Outcomes

  • Dual Task Standing Balance(Two-months following baseline)
  • Dual Task Verbal Reaction Time(Two-months following baseline)

Study Sites (1)

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