Fall RiskNCT06373276
The Effects of a Home-Based Fall Prevention Program on Community-Dwelling Elderly's Fall Risk Category
A study testing multiplanar balance training exercise with education and education only in people with Fall Risk, run by Dilshaad Basrai Vad at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Risk
- What is being tested?
- multiplanar balance training exercise with education and education only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Metro PT
New York, New York, 10021
dilshaad vad, DPT, 917-478-2444, dilshaad.vad@gmail.com
Lior Cohen, DPT, 9175549511
About this study
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.
Read more
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
- Being tested
- multiplanar balance training exercise with education, education only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiplanar balance training exercise with educationOther
7 minute daily balance training exercises
education onlyBehavioural
5 educational broshures
| Study group | Role | What they receive |
|---|---|---|
| Balance training | Experimental | multiplanar balance training exercise with education Receives: Other: multiplanar balance training exercise with education |
| control | Placebo comparator | Education only Receives: Behavioral: education only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up and Go Test measured in Seconds
walk 10 feet, turn around and walk back to start position
Measured: 1 minute
3 stage balance test measured in seconds
tandem gait stance measured up to 10 seconds
Measured: 20 seconds
30-second chair stand measured in repeitions
Stand up from chair, sit back down and repeat for 30 seconds
Measured: 40 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start15 Jan 2024
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dilshaad Basrai Vad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dilshaad Basrai Vad, Metro Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373276
- Sponsor's protocol ID
- 1511
- Status last verified
- Apr 2024
- First submitted
- 10 Aug 2022
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic information along with outcome measures will be shared with the dissertation team.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Home-Based Fall Prevention Program on Community-Dwelling Elderly's Fall Risk Category
- ClinicalTrials.gov ID
- NCT06373276
- Acronym / sponsor ID
- 1511
- Conditions
- Fall Risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dilshaad Basrai VadUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Balance training | Experimental | Other: multiplanar balance training exercise with educationmultiplanar balance training exercise with education |
| control | Placebo comparator | Behavioral: education onlyEducation only |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- • Unable to comprehend spoken English or communicate verbally in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multiplanar balance training exercise with education7 minute daily balance training exercises | Other | Balance training |
| education only5 educational broshures | Behavioural | control |
Primary outcome
Timed up and Go Test measured in Seconds
Time frame: 1 minute
walk 10 feet, turn around and walk back to start position
3 stage balance test measured in seconds
Time frame: 20 seconds
tandem gait stance measured up to 10 seconds
30-second chair stand measured in repeitions
Time frame: 40 seconds
Stand up from chair, sit back down and repeat for 30 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: Yes. Demographic information along with outcome measures will be shared with the dissertation team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multiplanar balance training exercise with education and education only in people with Fall Risk, run by Dilshaad Basrai Vad at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact dilshaad vad, DPT, MSPT (9174782444, dilshaad.vad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed up and Go Test measured in Seconds (time frame: 1 minute). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.