Clinical trial NCT06373276: The Effects of a Home-Based Fall Prevention Program on Community-Dwelling Elderly's Fall Risk Category
Official title: The Effects of a Home-Based Fall Prevention Program on Community-Dwelling Elderly's Fall Risk Category
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fall Risk
Lead sponsor: Metro Physical Therapy
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants in the multiplanar balance training home-based exercise and educational group (group A) will have a video, as well as written instructions, of the intervention and dosage, along with the five educational brochures loaded on their phone via the SAFE beta app. In the SAFE beta app, the participants will be prompted daily to click on the beta app to watch the demonstration of the interventional exercise. They are then prompted to begin their daily prescriptive intervention, which is a 7-day-a-week program for 12 weeks. Participants can view a video of the exercise intervention in real-time in order to "mirror" the exercises as they are completing the exercises.
Primary purpose: PREVENTION

Brief summary: The primary goal of this dissertation study is to determine if a home-based multiplanar balance training program with electronic assistance, will be effective in reducing one's fall risk category.

Hypothesis: After 12 weeks, there will be a statistically significant decrease in the fall risk category for individuals in a home-based multiplanar balance training and educational program with electronic assistance as compared to no change in the fall risk category for individuals in an educational control group with electronic assistance Hypothesis: To determine if an individual's fear of falling is lower following a home-based multiplanar balance training and educational program, with electronic assistance as compared to no change in fear of falling following an educational control group with electronic assistance post-intervention.

Hypothesis: An individual's quality of life will improve following a home-based multiplanar balance training and educational program, with electronic assistance as compared to no change in the quality of life following an educational control group with electronic assistance post-intervention.

Hypothesis: Adherence and feasibility will be greater with a home-based multiplanar balance training program, with electronic assistance as compared to a control group with electronic assistance.

Hypothesis: There will be a statistically significant inverse relationship between an individual's fear of falling and their fall risk category.


Eligibility criteria: Inclusion Criteria:

Age of 65 years or older

* Able to transfer and walk independently at least 10 feet without an assistive device
* Living independently (defined as transferring independently and perform activities of daily life independently) in a home, or condo in the community
* Maintain a single legged stance greater than or equal to 2 seconds and less than or equal to 10 seconds bilaterally
* A Mini-Cog test (a tool that assesses signs for dementia) score of 3 or greater (appendix IV)
* Possession of an I-Phone less than 7 years old
* Able to start within 2 weeks of enrollment

Exclusion Criteria:

* • Unable to comprehend spoken English or communicate verbally in English

  * Diagnosis of a central neurological disease
  * Diagnosis of cognitive disease
  * Surgery or hospitalization within the last 6 months
  * Active cancer and/or undergoing current treatment
  * Current utilization of a trainer
  * Current utilization of a physical therapist for gait, balance, or lower extremity issues

Primary outcomes:
measure: Timed up and Go Test measured in Seconds
timeFrame: 1 minute
measure: 3 stage balance test measured in seconds
timeFrame: 20 seconds
measure: 30-second chair stand measured in repeitions
timeFrame: 40 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Metro PT
state: New York
Study officials:
References: