Fall RiskNCT06396650
Assessment of Fall Risks and Subject-specific Training for Fall Reduction
A study testing Home-based training and Lab-based training in people with Fall Risk, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The target population of this project is older people with high risks of falls. About 30% community-dwelling individuals over 65 years of age fall each year and the rate of fall related injuries leading to loss of function and independence increases with age. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Fall Risk
- What is being tested?
- Home-based training and Lab-based training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 to 85 years old
- Have a family member at home for safety.
- There is no severe injury or pain at the lower extremities.
- With one or more falls in the past 12 months or walk with instability
- Individuals who are taking medication, there should be no planned medication changes for the study duration of 3.5 months.
- All the participants should be capable of independent walking.
Who cannot join
- Enrollment in another lower limb rehabilitation program;
- severe pain in the lower limbs;
- previous myocardial infarction
- Body weight over 280 lbs
- Cognitive impairment (Mini-Mental Status Examination (MMSE) score less than 25)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland Baltimore
Baltimore, Maryland, 21201
Li-Qun Zhang, Ph.D., 410-706-2125, L-Zhang@som.umaryland.edu
About this study
The target population of this project is older people with high risks of falls. About 30% community-dwelling individuals over 65 years of age fall each year and the rate of fall related injuries leading to loss of function and independence increases with age. Falls are the leading cause of fatal and non-fatal injuries and the leading cause traumatic brain injury in older adults. Slip-related falls in older adults comprise 40% of outdoor falls and are the leading cause of hip fracture or traumatic head injury. In 2012, 2.4 million non-fatal falls were treated in emergency room visits with $30 billion dollars spent on direct medical costs. In addition to fractures and traumatic brain injury, nonfatal falls frequently lead to reduced levels of activity, fear of falling, and reduced quality of life. Clearly, advancing the predictive, preventative, and rehabilitative methods aimed at reducing the risk of injurious falls in this population is imperative. Although falls are multi-factorial in nature, there has been few individualized assessment of the biomechanical causes of falls.
The purpose of this study is to conduct subject-specific training on older adults with fall risks with combined home-hospital rehabilitation. This project will involve rehabilitation interventions based on the characteristics of falling patterns and older adults with reduced capability controlling the balance. To conduct subject-specific fall prevention training. based on identified individual fall mechanisms.
Read the detailed description
Forty older adults (study group) with high risk of fall (i.e. with one or more fall in the past 12 months) will be recruited. The fall mechanisms will be examined in previous Aims 1 and 2 part of this study.
Assessments will be conducted to identify the fall risks and falling mechanisms by measuring subjects' responses to the movements of the footplates the subject stands on. Training procedures will then be designed for each subject, including training both in the research lab (once per week) and at home (three times per week) for six weeks. The subject will also revisit the lab for a follow-up assessment two months after the 6-week training.
Based on the identified falling mechanisms, a specific training for each subject will be set up using the sliding stepping fall rehabilitation system for one session per week over six weeks in the lab. The participants will also do home training exercises 3 times per week after initial in-lab instructed training. Participants will come to the lab and have biomechanical and clinical evaluations before and after the 6-week training (called Pre \& Post), and then at a two-month follow-up as the final evaluation for total three times of evaluations.
All the subjects will be informed about the experimental procedures, and sign an IRB approved consent form prior to study participation and experimental tests.
All participants will be protected from the risk of falling with a harness system. The harness is mounted in mobile cart. A researcher will push the mobile cart following the participant's walking while walking on the ground.
Home-based training: The older adults will also undergo corresponding home-based training. Training at home may include normal walking and strength training based on the results in-lab assessments for each older adult and research team instructions.
- . If the participant shows instability during walking in any specific perturbation directions or with excessive body swaying (left-right, forward-backward, or any oblique directions) based on the initial lab assessment, the participant will practice walking with a cellphone strapped on the chest in home training. A cellphone App will detect potential excessive body swaying in any directions and prompt the participant with real time audio-visual feedback to reduce sway in the specific directions. During the walking training at home, the participant will set up for a distance of a few meters to walk and repeat the walking distance for 12 to 15 times in a slow speed. the participant can take short break between the walking trials.
- For protection of falling risk, the participant needs to have a family member to help check the walking ground first before the walking to make sure the ground condition is good and clean.
- If the participant uses a cane or walker regularly, the participant will continue using the cane or walker during training at home with the cellphone attached.
- The participant should be monitored by a family member while doing the training at home.
- Training improvement will be evaluated in the weekly lab session. It is possible to make adjustment of the training program as the participant progresses.
- . If the subject is diagnosed with collapse-related vertical instability associated with falls, lower-limb muscle strengthening will be emphasized in the training. The subject may work out with a Shuttle Mini-Press, AB Squat machine, Rowing machine, or Upright Row-n-Ride at home. The several exercise machines are similar to each other in strengthening the lower limb muscles but the challenging level gradually increasing. The Shuttle Mini Press allows the subject to train in stable seated or in-bed postures. The AB Squat machine allows squatting exercise with the two feet always on the ground. The rower allows seated sliding training. The Upright Row-n-Ride allows training in up-and-down fashion. The research team will select one machine appropriate for the subject to take home. The exercise will be 3-5 sets a day and about 15 repetitions per set. In the beginning, the exercise can be slower and with fewer repetitions based on the subject's capability. The subject can take a short break between the strength training sets. As the subject progresses, the subject may change from one exercise machine to another.
- Conditions
- Fall Risk
- Being tested
- Home-based training, Lab-based training
- Keywords
- Fall prevention, Perturbation training, Multidirectional perturbation, Home-based training, Subject-specific training strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based trainingDevice
- If the participant shows instability in any specific perturbation directions or with excessive body swaying, the participant will practice walking with a cellphone strapped on the chest in-home training. A cellphone App will detect potential excessive body swaying in any directions and prompt the participant with real time audio-visual feedback to reduce sway in the specific directions.
- If the subject is diagnosed with collapse-related vertical instability, lower-limb muscle strengthening will be emphasized in the training. The subject may work out with a Shuttle Mini-Press, AB Squat machine, Rowing machine, or Upright Row-n-Ride. The Investigators will select one machine appropriate for the subject to take home. The exercise will be 3-5 sets a day and about 15 repetitions per set. In the beginning, the exercise can be slower and with fewer repetitions based on the subject's capability. As the subject progresses, the subject may change from one exercise machine to another.
Lab-based trainingDevice
In the weekly lab-based training session, the subject will do individualized training using the sliding stepping trainer, with a focus on the direction the subject showed higher risks of falling, as identified in the initial assessment. The sliding stepping trainer will generate perturbations of the footplates in those identified risky directions during stepping.
| Study group | Role | What they receive |
|---|---|---|
| Lab and home-based training | Experimental | Conduct balance training and/or lower-limb muscle strengthening in lab and at home Receives: Device: Home-based training; Device: Lab-based training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall risks
Berg Balance Scale (BBS) evaluation will be used which provides a value for fall risks assessment.
Measured: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
Secondary outcomes (4)
Lower limb muscle strength
The lower limb muscle strength will be measured manually by a researcher using dynamometry
Measured: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
Ground impact forces captured by forces plates during walking
Subjects' ground impact forces captured by forces plates during multidirectional perturbations during walking.
Measured: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
Body kinematcis during walking
Subjects' body kinematics measured by wearable IMUs during multidirectional perturbations during walking.
Measured: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
Body reactions against perturbations
Subjects' body reactions to multidirectional perturbations during walking. Reactions include loss of balance, recovery steps, and falls, which will be identified by videos.
Measured: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Dec 2025
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Qun Zhang, University of Maryland, Baltimore
- Investigators
- Li-Qun Zhang, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396650
- Sponsor's protocol ID
- HP-00108616-
- Status last verified
- Feb 2026
- First submitted
- 22 Apr 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fall Risks and Subject-specific Training for Fall Reduction
- ClinicalTrials.gov ID
- NCT06396650
- Acronym / sponsor ID
- HP-00108616-
- Conditions
- Fall Risk
- Keywords
- Fall prevention, Perturbation training, Multidirectional perturbation, Home-based training, Subject-specific training strategy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 2 May 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 target population of this project is older people with high risks of falls. About 30% community-dwelling individuals over 65 years of age fall each year and the rate of fall related injuries leading to loss of function and independence increases with age. Falls are the leading cause of fatal and non-fatal injuries and the leading cause traumatic brain injury in older adults. Slip-related falls in older adults comprise 40% of outdoor falls and are the leading cause of hip fracture or traumatic head injury. In 2012, 2.4 million non-fatal falls were treated in emergency room visits with $30 billion dollars spent on direct medical costs. In addition to fractures and traumatic brain injury, nonfatal falls frequently lead to reduced levels of activity, fear of falling, and reduced quality of life. Clearly, advancing the predictive, preventative, and rehabilitative methods aimed at reducing the risk of injurious falls in this population is imperative. Although falls are multi-factorial in nature, there has been few individualized assessment of the biomechanical causes of falls.
The purpose of this study is to conduct subject-specific training on older adults with fall risks with combined home-hospital rehabilitation. This project will involve rehabilitation interventions based on the characteristics of falling patterns and older adults with reduced capability controlling the balance. To conduct subject-specific fall prevention training. based on identified individual fall mechanisms.
Detailed description
Forty older adults (study group) with high risk of fall (i.e. with one or more fall in the past 12 months) will be recruited. The fall mechanisms will be examined in previous Aims 1 and 2 part of this study.
Assessments will be conducted to identify the fall risks and falling mechanisms by measuring subjects' responses to the movements of the footplates the subject stands on. Training procedures will then be designed for each subject, including training both in the research lab (once per week) and at home (three times per week) for six weeks. The subject will also revisit the lab for a follow-up assessment two months after the 6-week training.
Based on the identified falling mechanisms, a specific training for each subject will be set up using the sliding stepping fall rehabilitation system for one session per week over six weeks in the lab. The participants will also do home training exercises 3 times per week after initial in-lab instructed training. Participants will come to the lab and have biomechanical and clinical evaluations before and after the 6-week training (called Pre \& Post), and then at a two-month follow-up as the final evaluation for total three times of evaluations.
All the subjects will be informed about the experimental procedures, and sign an IRB approved consent form prior to study participation and experimental tests.
All participants will be protected from the risk of falling with a harness system. The harness is mounted in mobile cart. A researcher will push the mobile cart following the participant's walking while walking on the ground.
Home-based training: The older adults will also undergo corresponding home-based training. Training at home may include normal walking and strength training based on the results in-lab assessments for each older adult and research team instructions.
- . If the participant shows instability during walking in any specific perturbation directions or with excessive body swaying (left-right, forward-backward, or any oblique directions) based on the initial lab assessment, the participant will practice walking with a cellphone strapped on the chest in home training. A cellphone App will detect potential excessive body swaying in any directions and prompt the participant with real time audio-visual feedback to reduce sway in the specific directions. During the walking training at home, the participant will set up for a distance of a few meters to walk and repeat the walking distance for 12 to 15 times in a slow speed. the participant can take short break between the walking trials.
- For protection of falling risk, the participant needs to have a family member to help check the walking ground first before the walking to make sure the ground condition is good and clean.
- If the participant uses a cane or walker regularly, the participant will continue using the cane or walker during training at home with the cellphone attached.
- The participant should be monitored by a family member while doing the training at home.
- Training improvement will be evaluated in the weekly lab session. It is possible to make adjustment of the training program as the participant progresses.
- . If the subject is diagnosed with collapse-related vertical instability associated with falls, lower-limb muscle strengthening will be emphasized in the training. The subject may work out with a Shuttle Mini-Press, AB Squat machine, Rowing machine, or Upright Row-n-Ride at home. The several exercise machines are similar to each other in strengthening the lower limb muscles but the challenging level gradually increasing. The Shuttle Mini Press allows the subject to train in stable seated or in-bed postures. The AB Squat machine allows squatting exercise with the two feet always on the ground. The rower allows seated sliding training. The Upright Row-n-Ride allows training in up-and-down fashion. The research team will select one machine appropriate for the subject to take home. The exercise will be 3-5 sets a day and about 15 repetitions per set. In the beginning, the exercise can be slower and with fewer repetitions based on the subject's capability. The subject can take a short break between the strength training sets. As the subject progresses, the subject may change from one exercise machine to another.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lab and home-based training | Experimental | Device: Home-based training, Device: Lab-based trainingConduct balance training and/or lower-limb muscle strengthening in lab and at home |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 60 to 85 years old
- Have a family member at home for safety.
- There is no severe injury or pain at the lower extremities.
- With one or more falls in the past 12 months or walk with instability
- Individuals who are taking medication, there should be no planned medication changes for the study duration of 3.5 months.
Key exclusion criteria (5 listed)
- Enrollment in another lower limb rehabilitation program;
- severe pain in the lower limbs;
- previous myocardial infarction
- Body weight over 280 lbs
- Cognitive impairment (Mini-Mental Status Examination (MMSE) score less than 25)
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 |
|---|---|---|
| Home-based training1. If the participant shows instability in any specific perturbation directions or with excessive body swaying, the participant will practice walking with a cellphone strapped on the chest in-home training. A cellphone App will detect potential excessive body swaying in any directions and prompt the participant with real time audio-visual feedback to reduce sway in the specific directions. 2. If the subject is diagnosed with collapse-related vertical instability, lower-limb muscle strengthening will be emphasized in the training. The subject may work out with a Shuttle Mini-Press, AB Squat machine, Rowing machine, or Upright Row-n-Ride. The Investigators will select one machine appropriate for the subject to take home. The exercise will be 3-5 sets a day and about 15 repetitions per set. In the beginning, the exercise can be slower and with fewer repetitions based on the subject's capability. As the subject progresses, the subject may change from one exercise machine to another. | Device | Lab and home-based training |
| Lab-based trainingIn the weekly lab-based training session, the subject will do individualized training using the sliding stepping trainer, with a focus on the direction the subject showed higher risks of falling, as identified in the initial assessment. The sliding stepping trainer will generate perturbations of the footplates in those identified risky directions during stepping. | Device | Lab and home-based training |
Primary outcome
Fall risks
Time frame: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
Berg Balance Scale (BBS) evaluation will be used which provides a value for fall risks assessment.
4 secondary outcomes
Lower limb muscle strength
Time frame: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
Ground impact forces captured by forces plates during walking
Time frame: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
Body kinematcis during walking
Time frame: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
Body reactions against perturbations
Time frame: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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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.
Li-Qun Zhang principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based training and Lab-based training in people with Fall Risk, run by University of Maryland, Baltimore 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 6 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: looking for participants now, as of the sponsor's last update on 10 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zongpan Li (410-706-3242, zongpan.li@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall risks (time frame: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training). 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 10 Feb 2026.