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

NCT ID: NCT06373276

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fall Risk

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
The primary investigator, who delivers the treatment, is blinded to to the performance outcome measures.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Balance training

multiplanar balance training exercise with education

Group Type EXPERIMENTAL

multiplanar balance training exercise with education

Intervention Type OTHER

7 minute daily balance training exercises

control

Education only

Group Type PLACEBO_COMPARATOR

education only

Intervention Type BEHAVIORAL

5 educational broshures

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

multiplanar balance training exercise with education

7 minute daily balance training exercises

Intervention Type OTHER

education only

5 educational broshures

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dilshaad Basrai Vad

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dilshaad Basrai Vad

Primary Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Metro PT

New York, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

dilshaad vad, DPT, MSPT

Role: CONTACT

9174782444

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

dilshaad vad, DPT

Role: primary

917-478-2444

Lior Cohen, DPT

Role: backup

9175549511

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1511

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Aging and Task-specific Training to Reduce Falls
NCT07094659 RECRUITING PHASE1/PHASE2