Fall PreventionNCT01621958
Motor Training for Fall Prevention
A study testing Repeated perturbation training and Minimal perturbation training in people with Fall Prevention, run by University of Illinois at Chicago at 1 site in United States.
Trial summary
Slip-related falls often cause injury; these often have catastrophic consequences, even among the healthiest older persons. Establishing a retainable preventive training regimen against slip-related falls would, without doubt, have major public health implications. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Prevention
- What is being tested?
- Repeated perturbation training and Minimal perturbation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Apr 2012
- 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
- Subjects with no known history of musculoskeletal, neurological, cardiovascular, or pulmonary impairment that may affect their ability to perform the testing procedures will be included.
- Subjects in the balance-impaired group will specifically include subjects with unilateral or bilateral vestibular disorders and individuals with balance deterioration due to aging.
- Subjects in this group must be able ambulate independently for at least 5 meters and score 48/56 on the Berg Balance Scale, and must have no Central Nervous System disorders beyond vestibular disorders and no central/peripheral motor impairments.
Who cannot join
- The exclusion criteria include the following:
- using any sedative of any type,
- having known history of osteoporosis,
- having any clinically significant functional impairment related to a specific musculoskeletal, neurological, or cardiopulmonary disease,
- ultrasound calcaneus bone mineral density T score < -1 (osteoporosis )
- Mini-Mental State exam score < 25 (impaired cognition),
- timed up-and-go > 13.5 sec (impaired mobility).
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Gait and Movement Analysis Laboratory
Chicago, Illinois, 60612
About this study
Official title: Motor Training for Fall Prevention: Adaptation and Retention in Older Adults
Slip-related falls often cause injury; these often have catastrophic consequences, even among the healthiest older persons. Establishing a retainable preventive training regimen against slip-related falls would, without doubt, have major public health implications. In this study, investigators will demonstrate that older adults can significantly reduce their near-term risk of backward balance loss and falls through motor training with multiple protected slip exposure, and such adaptive improvements from such prophylactic training regimen can be retained over the course of a year.
Read the detailed description
Slip-related falls often cause catastrophic injury for both frail and healthy older persons. Investigators have shown that, with motor training by repeated exposure to slips during walking, young adults are able to traverse a potential slipping hazard without losing their balance, regardless of whether a slip actually occurs or not. It is highly unlikely that these effects could be attributed to education or heightened awareness of the slipping threat alone. Furthermore, investigators have demonstrated that these improved motor skills acquired from a single session can be retained 4-6 months or longer upon re-testing, making such intervention highly attractive. Of greater interest, however, is the extent to which older adults can acquire and retain similar protective skills upon such training. This has not been tested to date. Also unknown is how potential confounding factors such as an older adult's functional status might interact with the training. These issues are of importance in that establishing a retainable preventive training regimen against slip-related falls would, without doubt, have major public health implications.
In this study, investigators will demonstrate that older adults can significantly reduce their near-term risk of backward balance loss and falls through motor training by repeated exposure to simulated slips interspersed with no-slip trials. Investigators will verify that awareness or observational learning alone cannot substitute for motor training through an awareness-control group. Investigators will then determine the extent to which adaptive improvements are retained over the course of a year. Finally, investigators will verify that although a single slip exposure may yield some retainable effect, this intensity control group will exhibit significantly less favorable long-term effect on the control of center of mass stability, body weight support, balance loss and fall upon slipping than the motor training group with repeated slips. In addition, investigator expect that the intensity-control group will also have a higher self-reported incidence of falls during the 12-month period than the motor training group with multiple slip exposure.
- Conditions
- Fall Prevention
- Being tested
- Repeated perturbation training, Minimal perturbation training
- Keywords
- balance loss, dynamic stability, motor learning, plasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated perturbation trainingBehavioural
Also called Repeated slip training
One session consisting of 24 slips total interspersed with 16 nonslip trials (1 block of 8 slips, 3 non-slips, 2nd block of 8 slips, 3 non-slips, a mixed block consisting of 8 slips and 10 non-slips). Retest consisting of one slip exposure at either 6 months, 9 months or 12 months.
Minimal perturbation trainingBehavioural
Also called Single slip exposure
One session consisting of a single slip exposure. Retest consisting of one slip exposure at either 6 months, 9 months or 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Motor training | Experimental | Not described Receives: Behavioral: Repeated perturbation training |
| Intensity control | Placebo comparator | Not described Receives: Behavioral: Minimal perturbation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall incidence
Measured: 6 months
Secondary outcomes (1)
Dynamic stability
The dynamic stability will be evaluated based on the dynamic relationship of motion state (i.e., the combination of position and velocity) between the center of mass and the base of support. It will be calculated as the shortest distance from the instantaneous motion state of the center of mass to the threshold against backward fall. It is a dimensionless variable.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startSep 2008
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PreventionStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Tanvi Bhatt, University of Illinois at Chicago
- Investigators
- Yi-Chung Pai, PhD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621958
- Sponsor's protocol ID
- 2001-0821
- Other IDs
- 5R01AG029616-03
- Status last verified
- Nov 2019
- First submitted
- 12 Jun 2012
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Training for Fall Prevention: Adaptation and Retention in Older Adults
- ClinicalTrials.gov ID
- NCT01621958
- Acronym / sponsor ID
- 2001-0821
- Conditions
- Fall Prevention
- Keywords
- balance loss, dynamic stability, motor learning, plasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Sep 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 Jun 2012 (estimated)
- 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.
Slip-related falls often cause injury; these often have catastrophic consequences, even among the healthiest older persons. Establishing a retainable preventive training regimen against slip-related falls would, without doubt, have major public health implications. In this study, investigators will demonstrate that older adults can significantly reduce their near-term risk of backward balance loss and falls through motor training with multiple protected slip exposure, and such adaptive improvements from such prophylactic training regimen can be retained over the course of a year.
Detailed description
Slip-related falls often cause catastrophic injury for both frail and healthy older persons. Investigators have shown that, with motor training by repeated exposure to slips during walking, young adults are able to traverse a potential slipping hazard without losing their balance, regardless of whether a slip actually occurs or not. It is highly unlikely that these effects could be attributed to education or heightened awareness of the slipping threat alone. Furthermore, investigators have demonstrated that these improved motor skills acquired from a single session can be retained 4-6 months or longer upon re-testing, making such intervention highly attractive. Of greater interest, however, is the extent to which older adults can acquire and retain similar protective skills upon such training. This has not been tested to date. Also unknown is how potential confounding factors such as an older adult's functional status might interact with the training. These issues are of importance in that establishing a retainable preventive training regimen against slip-related falls would, without doubt, have major public health implications.
In this study, investigators will demonstrate that older adults can significantly reduce their near-term risk of backward balance loss and falls through motor training by repeated exposure to simulated slips interspersed with no-slip trials. Investigators will verify that awareness or observational learning alone cannot substitute for motor training through an awareness-control group. Investigators will then determine the extent to which adaptive improvements are retained over the course of a year. Finally, investigators will verify that although a single slip exposure may yield some retainable effect, this intensity control group will exhibit significantly less favorable long-term effect on the control of center of mass stability, body weight support, balance loss and fall upon slipping than the motor training group with repeated slips. In addition, investigator expect that the intensity-control group will also have a higher self-reported incidence of falls during the 12-month period than the motor training group with multiple slip exposure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor training | Experimental | Behavioral: Repeated perturbation training |
| Intensity control | Placebo comparator | Behavioral: Minimal perturbation training |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Subjects with no known history of musculoskeletal, neurological, cardiovascular, or pulmonary impairment that may affect their ability to perform the testing procedures will be included.
- Subjects in the balance-impaired group will specifically include subjects with unilateral or bilateral vestibular disorders and individuals with balance deterioration due to aging.
- Subjects in this group must be able ambulate independently for at least 5 meters and score 48/56 on the Berg Balance Scale, and must have no Central Nervous System disorders beyond vestibular disorders and no central/peripheral motor impairments.
Key exclusion criteria (7 listed)
- using any sedative of any type,
- having known history of osteoporosis,
- having any clinically significant functional impairment related to a specific musculoskeletal, neurological, or cardiopulmonary disease,
- ultrasound calcaneus bone mineral density T score < -1 (osteoporosis )
- Mini-Mental State exam score < 25 (impaired cognition),
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 |
|---|---|---|
| Repeated perturbation trainingAlso: Repeated slip trainingOne session consisting of 24 slips total interspersed with 16 nonslip trials (1 block of 8 slips, 3 non-slips, 2nd block of 8 slips, 3 non-slips, a mixed block consisting of 8 slips and 10 non-slips). Retest consisting of one slip exposure at either 6 months, 9 months or 12 months. | Behavioural | Motor training |
| Minimal perturbation trainingAlso: Single slip exposureOne session consisting of a single slip exposure. Retest consisting of one slip exposure at either 6 months, 9 months or 12 months. | Behavioural | Intensity control |
Primary outcome
Fall incidence
Time frame: 6 months
1 secondary outcome
Dynamic stability
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
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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.
Yi-Chung Pai, PhD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated perturbation training and Minimal perturbation training in people with Fall Prevention, run by University of Illinois at Chicago 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 3 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: finished, as of the sponsor's last update on 6 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall incidence (time frame: 6 months). 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 6 Nov 2019.