The Effects of a Home-Based Fall Prevention Program on Co... | NCT06373276

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

NCT06373276

Sponsor

Dilshaad Basrai Vad

Status

Unknown status

Last Update Posted

Apr 18, 2024Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Fall Risk

Interventions

multiplanar balance training exercise with education
education only

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2024Actual

Primary Completion Date

Apr 2024Estimated

Completion Date

May 2024Estimated

First Submitted Date

Aug 10, 2022

First Submission Date that Met QC Criteria

Apr 17, 2024

First Posted Date

Apr 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2024

Last Update Posted Date

Apr 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
multiplanar balance training exercise with education	Other	7 minute daily balance training exercises	Balance training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
dilshaad vad, DPT, MSPT	Contact	9174782444		dilshaad.vad@gmail.com

Facility	Status	City	State	ZIP	Country	Contacts
Metro PT	Recruiting	New York	New York	10021	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

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

Access Criteria

Not provided

URL

Not provided

ID	Term
D004522	Educational Status

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics

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.