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Accidental FallNCT05771818

A Community-Based Falls Prevention Program for Adults At-Risk for Falls

A study testing Falls Prevention Program in people with Accidental Fall and Neurologic Disorder, run by University of St. Augustine for Health Sciences at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this interventional study is to implement a Falls Prevention Program to impact the risk and injuries related to falls. The main question is to learn and examine the effects of a falls prevention program on the functional mobility of adults at risk for falls. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
What is being tested?
Falls Prevention Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
13 Aug 2020to 1 Jan 2026
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 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female
  • Age range: 18-100
  • At risk for falls (as determined by any of the following:
  • Positive history of falls within 5 years
  • Timed up and Go <45 seconds
  • Medical clearance for participation in Falls Prevention Program
  • Able to attend biweekly sessions for 5 weeks

Who cannot join

  • Unable to independently kneel and sit and on the floor and return to chair
  • Taking prescription anti-coagulants without physician clearance to participate
  • No medical clearance for participation in Falls Prevention Program
  • Unable to attend bi-weekly on-site sessions for 5 weeks
  • Other reasons that may limit participation in intervention

Trial locations and contacts

1 site in 1 country.

Miguel Garcia, PT, DPT, EdD contact

786-725-4047

mgarcia@usa.edu

Gabriel Somarriba, PT, DPT, EdD contact

786-725-4010

gsomarriba@usa.edu

United States1 site, 1 recruiting
  • University of St Augustine for Health Science

    Miami, Florida, 33134

    Gabriel Somarriba, EdD, 786-725-4045 ext. 4145, gsomarriba@usa.edu

    Miguel Garcia, EdD, 786-725-4047 ext. 4147, mgarcia@usa.edu

    Recruiting

Other trials in United States

About this study

The goal of this interventional study is to implement a Falls Prevention Program to impact the risk and injuries related to falls. The main question is to learn and examine the effects of a falls prevention program on the functional mobility of adults at risk for falls.

Participants will:

  • Complete functional mobility assessments
  • Complete Falls prevention obstacle course training
  • Complete Falls Strategies Training
  • Complete walking and balance training
Read the detailed description

The purpose of the study is to implement a Fall Prevention Program to impact the risk and injuries related to falls. This study is innovative in that (1) it will be implemented as a community service program for the first time in the United States (2) it will attempt to standardize an obstacle course as a reliable and valid outcome measure for balance and falls (3) it will incorporate community outreach learning opportunity for students in a doctor of physical therapy curriculum at the University of St. Augustine for Health Sciences and (4) it will assess effectiveness using a variety of standardized and valid outcome measures to address balance and coordination deficits, fear of falling, incidence of falling, gait speed, feasibility and patient perception and satisfaction.

Specific Aim 1: To examine the effects of a falls prevention program on the functional mobility of adults at risk for falls. Hypothesis: Physical exercise and dynamic balance training has been shown to be effective in decreasing risk for falls. The Falls Prevention Program will have a positive effect on balance, gait speed, fear of falls, incidence of falls and incorporation of falls techniques.

Specific Aim 2: To create a falls prevention program within a Doctor of Physical Therapy curriculum. Hypothesis: Community outreach which are learning opportunities that benefit the community at large are part of the Doctor of Physical Therapy curriculum. It is expected that the Falls Prevention Program will be successfully integrated into the Geriatric Rehabilitation for Physical Therapy course with appropriate participation from the students.

Specific Aim 3: Evaluate the reliability and validity of an obstacle course as a measure of fall risk. Hypothesis: The Falls Prevention Program includes a 17-item obstacle course that significantly challenges the participant's functional mobility and standing dynamic balance. It is expected that the obstacle course will serve as a reliable and valid test for the assessment for balance and mobility.

Specific Aim 4: Evaluate the acceptability of a Falls Prevention Program. Hypothesis: There are no current falls prevention programs available to the community as a free community service program. It is believed that the program will be accepted by the community as well as the faculty and students leading the program.

Specific Aim 5: Determine whether disease moderates the relationship between the effects of a Falls Prevention Program and functional mobility of adults at risk for falls. Hypothesis: Fall Prevention Programs to improve balance and functional mobility have been effective for participants at risk for falls. This program will aim to assess the impact a Falls Prevention Program has on different populations.

Specific Aim 6: Determine the effects of the Falls Prevention Program on Anticipatory Postural Assessment and Compensatory Postural Assessment.

Hypothesis: Older adults will improve their Anticipatory Postural Assessment and Compensatory Postural Assessment (less magnitude and faster responses of muscle activity along with less body displacement) in response to balance perturbations a a result of the intervention.

Being tested
Falls Prevention Program
Keywords
Falls, Balance, Neurological, Geriatrics, Risk
Medical subject headings
Nervous System Diseases, Frailty, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Falls Prevention ProgramOther

    The intervention consists of 10 sessions. One session a week consists of obstacle course training. The other session focuses on falls strategies training and walking and balance exercises. Each session lasts approximately 1.5 hours.

Study groups in NCT05771818
Study groupRoleWhat they receive
Falls Prevention trainingExperimentalThe intervention consists of 10 sessions. One session a week consists of obstacle course training. The other session consists of falls strategies and walking and balance exercises. Each session lasts approximately 1.5 hours
Receives: Other: Falls Prevention Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes over time in Activities-Specific Balance Confidence Scale from baseline to one year

    The Activities-Specific Balance Confidence Scale is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness.

    Measured: Baseline, 6-weeks, 6-months and 1-year post intervention.

  2. Changes in Falls Efficacy Scale - International from baseline to 1-year post

    A self-administered questionnaire designed to assess fear of falling in mainly community-dwelling older population

    Measured: Baseline, 6-weeks, 6-months and 1-year post intervention.

  3. Changes in Berg Balance Test from baseline to 1-year post

    The Berg Balance Test is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks

    Measured: Baseline, 6-weeks, 6-months and 1-year post intervention.

  4. Changes in Functional Reach Test from baseline to 1-year post

    The Functional Reach measures the participant to complete a forward reach while in a standing position

    Measured: Baseline, 6-weeks, 6-months and 1-year post intervention.

  5. Changes in Single Limb Stance from baseline to 1-year post

    The Single Limb Stance test is a measurement to assess the individual's ability to stand unsupported on one limb.

    Measured: Baseline, 6-weeks, 6-months and 1-year post intervention.

  6. Changes in Tandem Stance from baseline to 1-year post

    The Tandem Stance test is a measurement to assess the individual's ability to stand unsupported with one foot directly in front of the other

    Measured: Baseline, 6-weeks, 6-months and 1-year post intervention.

  7. Changes in 10-Meter Walk Test from baseline to 1-year post

    The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance

    Measured: Baseline, 6-weeks, 6-months and 1-year post intervention.

  8. Changes in 6-Minute Walk Test from baseline to 1-year post

    The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance

    Measured: Baseline, 6-weeks, 6-months and 1-year post intervention.

  9. Changes in Timed Up and Go from baseline to 1-year post

    The Timed Up and Go test is a measure that assess fall risk by performing sit to stand and walking

    Measured: Baseline, 6-weeks, 6-months and 1-year post intervention.

  10. Changes in Anticipatory & Compensatory Postural Assessment from baseline to 1-year post

    Electromyography measure of postural stability in standing

    Measured: Baseline, 6-weeks, 6-months and 1-year post intervention.

  11. Changes in Obstacle Course performance from baseline to 1-year post

    The obstacle course measures time to complete 17 obstacles and errors performed on each of the obstacles

    Measured: Baseline, 6-weeks, 6-months and 1-year post intervention.

  12. Changes in falls occurrences from baseline to 1-year post

    The questionnaire assesses incidence of falls, falls with injuries and falls requiring hospitalization

    Measured: Baseline, 6-weeks, 6-months and 1-year post intervention.

  13. Changes Physical Activity Intensity Monitoring from baseline to 1-year post intervention

    Heart rate monitoring during all components of falls prevention program

    Measured: Baseline, 6-weeks, 6-months and 1-year post intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2023
  2. Study start13 Aug 2020
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05771818
Sponsor's protocol ID
UR-0627-320
Status last verified
Mar 2023
First submitted
5 Mar 2023
Last updated
16 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Weerdesteyn V, Rijken H, Geurts AC, Smits-Engelsman BC, Mulder T, Duysens J. A five-week exercise program can reduce falls and improve obstacle avoidance in the elderly. Gerontology. 2006;52(3):131-41. doi: 10.1159/000091822.

    PubMed 16645293
  • Rosendahl E, Gustafson Y, Nordin E, Lundin-Olsson L, Nyberg L. A randomized controlled trial of fall prevention by a high-intensity functional exercise program for older people living in residential care facilities. Aging Clin Exp Res. 2008 Feb;20(1):67-75. doi: 10.1007/BF03324750.

    PubMed 18283231
  • Gallo E, Stelmach M, Frigeri F, Ahn DH. Determining Whether a Dosage-Specific and Individualized Home Exercise Program With Consults Reduces Fall Risk and Falls in Community-Dwelling Older Adults With Difficulty Walking: A Randomized Control Trial. J Geriatr Phys Ther. 2018 Jul/Sep;41(3):161-172. doi: 10.1519/JPT.0000000000000114.

    PubMed 27893567
  • Hewitt J, Goodall S, Clemson L, Henwood T, Refshauge K. Progressive Resistance and Balance Training for Falls Prevention in Long-Term Residential Aged Care: A Cluster Randomized Trial of the Sunbeam Program. J Am Med Dir Assoc. 2018 Apr;19(4):361-369. doi: 10.1016/j.jamda.2017.12.014.

    PubMed 29402651
  • Gudnadottir M, Thorsteinsdottir TK, Mogensen B, Aspelund T, Thordardottir EB. Accidental injuries among older adults: An incidence study. Int Emerg Nurs. 2018 Sep;40:12-17. doi: 10.1016/j.ienj.2018.03.003. Epub 2018 Apr 13.

    PubMed 29661594
  • Stewart Williams J, Kowal P, Hestekin H, O'Driscoll T, Peltzer K, Yawson A, Biritwum R, Maximova T, Salinas Rodriguez A, Manrique Espinoza B, Wu F, Arokiasamy P, Chatterji S; SAGE collaborators. Prevalence, risk factors and disability associated with fall-related injury in older adults in low- and middle-incomecountries: results from the WHO Study on global AGEing and adult health (SAGE). BMC Med. 2015 Jun 23;13:147. doi: 10.1186/s12916-015-0390-8.

    PubMed 26099794
  • Oyetunji TA, Ong'uti SK, Bolorunduro OB, Gonzalez DO, Cornwell EE, Haider AH. Epidemiologic trend in elderly domestic injury. J Surg Res. 2012 Apr;173(2):206-11. doi: 10.1016/j.jss.2011.05.003. Epub 2011 May 31.

    PubMed 21704329
  • Saveman BI, Bjornstig U. Unintentional injuries among older adults in northern Sweden--a one-year population-based study. Scand J Caring Sci. 2011 Mar;25(1):185-93. doi: 10.1111/j.1471-6712.2010.00810.x.

    PubMed 20626698
  • Scariot V, Rios JL, Claudino R, Dos Santos EC, Angulski HBB, Dos Santos MJ. Both anticipatory and compensatory postural adjustments are adapted while catching a ball in unstable standing posture. J Bodyw Mov Ther. 2016 Jan;20(1):90-97. doi: 10.1016/j.jbmt.2015.06.007. Epub 2015 Jun 19.

    PubMed 26891642
  • Dos Santos M, Somarriba G, Garcia M, Garcia C. A Multitask Fall Prevention Program for People with Parkinson's Disease: Feasibility and Effects on Static and Dynamic Postural Control: A Preliminary Study. NeuroRehabilitation. 2026 Sep 8:10538135261481535. doi: 10.1177/10538135261481535. Online ahead of print.

    PubMed 42709496

Questions about this trial

What is this clinical trial studying?

A study testing Falls Prevention Program in people with Accidental Fall and Neurologic Disorder, run by University of St. Augustine for Health Sciences 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 5 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 16 Mar 2023. 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. 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 Miguel Garcia, PT, DPT, EdD (786-725-4047, mgarcia@usa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes over time in Activities-Specific Balance Confidence Scale from baseline to one year (time frame: Baseline, 6-weeks, 6-months and 1-year post intervention.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05771818, which also lists 10 linked publications.

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 16 Mar 2023.

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