The Effects of a Home-Based Fall Prevention Program on Community-Dwelling Elderly's Fall Risk Category

NCT06373276 | Recruiting

• 1 other identifier: 1511
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall Risk

Outcome Measures

Primary Outcomes (3)

• Timed up and Go Test measured in Seconds

  walk 10 feet, turn around and walk back to start position

  1 minute

• 3 stage balance test measured in seconds

  tandem gait stance measured up to 10 seconds

  20 seconds

• 30-second chair stand measured in repeitions

  Stand up from chair, sit back down and repeat for 30 seconds

  40 seconds

Study Arms (2)

Balance training

EXPERIMENTAL

multiplanar balance training exercise with education

Other: multiplanar balance training exercise with education

control

PLACEBO COMPARATOR

Education only

Behavioral: education only

Interventions

multiplanar balance training exercise with education OTHER

7 minute daily balance training exercises

Balance training

education only BEHAVIORAL

5 educational broshures

control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dilshaad Basrai Vad: lead

Study Sites (1)

Metro PT

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

dilshaad vad, DPT, MSPT

CONTACT

9174782444; dilshaad.vad@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The primary investigator, who delivers the treatment, is blinded to to the performance outcome measures.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: April 18, 2024
• Study Start: January 15, 2024
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after the trial ends. The data will be available for 6 months

Locations

US (1)