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

April 17, 2024 updated by: Dilshaad Basrai Vad

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Metro PT
        • Contact:
        • Contact:
          • Lior Cohen, DPT
          • Phone Number: 9175549511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Balance training
multiplanar balance training exercise with education
Other: multiplanar balance training exercise with education
7 minute daily balance training exercises
Placebo Comparator: control
Education only
Behavioral: education only
5 educational broshures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed up and Go Test measured in Seconds
Time Frame: 1 minute
walk 10 feet, turn around and walk back to start position
1 minute
3 stage balance test measured in seconds
Time Frame: 20 seconds
tandem gait stance measured up to 10 seconds
20 seconds
30-second chair stand measured in repeitions
Time Frame: 40 seconds
Stand up from chair, sit back down and repeat for 30 seconds
40 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dilshaad Basrai Vad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 1511

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Demographic information along with outcome measures will be shared with the dissertation team.

IPD Sharing Time Frame

Data will be available after the trial ends. The data will be available for 6 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fall Risk

Clinical Trials on multiplanar balance training exercise with education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe