Balance, PosturalNCT02126488
Effect of Adaptive Training for Balance Recovery
A study testing treadmill slip perturbation and observation training in people with Balance, Postural and Prevention, Accident, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The long-term objective of this research is a prophylactic approach that can reduce the incidence of falls and the resulting injuries among older adults at risk and thus reduce its escalating medical cost. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Balance, Postural, Prevention, Accident
- What is being tested?
- treadmill slip perturbation and observation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 15 Dec 2022
- 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.
Who cannot join
- Ultrasound calcaneus bone mineral density T score < -2.5 (osteoporotic)
- Mini-Mental State exam score < 25 (cognitive impairment)
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: Perturbation Training for Fall-risk Reduction Among Older Adults
The long-term objective of this research is a prophylactic approach that can reduce the incidence of falls and the resulting injuries among older adults at risk and thus reduce its escalating medical cost. This project explores perturbation training through the use of treadmill device and a motor learning approach, in which experience with slip-like perturbation generated by that treadmill is used to prepare the motor system to develop and then put to use fall-resisting skills outside of training environment (cross-environment transfer). The computer-controlled treadmill is portable, safe and easy to operate, thus conducive for use in clinics or community centers. The study logically builds on and complements the team's previous and current research programs, and will further test that after such a single session, older adults at risk can retain such cross-environment transfer and reduce their likelihood of falls in everyday living for the next 6 to 12 months. Finally, the study will explore that such reduction of falls does not come merely from these persons' familiarity with the training or testing setup, protocol and environments.
- Conditions
- Balance, Postural, Prevention, Accident
- Being tested
- treadmill slip perturbation, treadmill training placebo, observation training
- Keywords
- treadmill training, generalization, retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treadmill slip perturbationBehavioural
Group A will receive perturbation training on a treadmill with precisely controlled slip-like displacements and then encounter an unannounced novel slip during over-ground walking.
treadmill training placeboBehavioural
An age-matched control group (Group B) will receive only placebo training (on the same treadmill for the same duration but without perturbation) but encounter an identical novel slip during their over-ground walking.
observation trainingBehavioural
An age-matched observation-training group (Group C) will watch a training video and slides. When exposed to an identical novel slip in over-ground walking, they will know where and how the slip is going to occur and how to resist a fall.
| Study group | Role | What they receive |
|---|---|---|
| treadmill perturbation | Experimental | treadmill slip perturbation Receives: Behavioral: treadmill slip perturbation |
| treadmill placebo | Placebo comparator | treadmill training placebo Receives: Behavioral: treadmill training placebo |
| observation | Sham comparator | observation training Receives: Behavioral: observation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall incidence
Measured: 1 year
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 posted30 Apr 2014 (estimated)
- Study startJun 2014
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Balance, PosturalStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Tanvi Bhatt, University of Illinois Chicago
- Investigators
- Tanvi Bhatt, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126488
- Sponsor's protocol ID
- 2000-0788
- Other IDs
- R01AG044364
- Status last verified
- May 2024
- First submitted
- 25 Apr 2014
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang Y, Wang S, Liu X, Lee A, Pai YC, Bhatt T. Can a single session of treadmill-based slip training reduce daily life falls in community-dwelling older adults? A randomized controlled trial. Aging Clin Exp Res. 2022 Jul;34(7):1593-1602. doi: 10.1007/s40520-022-02090-3. Epub 2022 Mar 2.
PubMed 35237948
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perturbation Training for Fall-risk Reduction Among Older Adults
- ClinicalTrials.gov ID
- NCT02126488
- Acronym / sponsor ID
- 2000-0788
- Conditions
- Balance, Postural, Prevention, Accident
- Keywords
- treadmill training, generalization, retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jun 2014
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 30 Apr 2014 (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.
The long-term objective of this research is a prophylactic approach that can reduce the incidence of falls and the resulting injuries among older adults at risk and thus reduce its escalating medical cost. This project explores perturbation training through the use of treadmill device and a motor learning approach, in which experience with slip-like perturbation generated by that treadmill is used to prepare the motor system to develop and then put to use fall-resisting skills outside of training environment (cross-environment transfer). The computer-controlled treadmill is portable, safe and easy to operate, thus conducive for use in clinics or community centers. The study logically builds on and complements the team's previous and current research programs, and will further test that after such a single session, older adults at risk can retain such cross-environment transfer and reduce their likelihood of falls in everyday living for the next 6 to 12 months. Finally, the study will explore that such reduction of falls does not come merely from these persons' familiarity with the training or testing setup, protocol and environments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| treadmill perturbation | Experimental | Behavioral: treadmill slip perturbationtreadmill slip perturbation |
| treadmill placebo | Placebo comparator | Behavioral: treadmill training placebotreadmill training placebo |
| observation | Sham comparator | Behavioral: observation trainingobservation training |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 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.
Key exclusion criteria (2 listed)
- Ultrasound calcaneus bone mineral density T score < -2.5 (osteoporotic)
- Mini-Mental State exam score < 25 (cognitive impairment)
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 |
|---|---|---|
| treadmill slip perturbationGroup A will receive perturbation training on a treadmill with precisely controlled slip-like displacements and then encounter an unannounced novel slip during over-ground walking. | Behavioural | treadmill perturbation |
| treadmill training placeboAn age-matched control group (Group B) will receive only placebo training (on the same treadmill for the same duration but without perturbation) but encounter an identical novel slip during their over-ground walking. | Behavioural | treadmill placebo |
| observation trainingAn age-matched observation-training group (Group C) will watch a training video and slides. When exposed to an identical novel slip in over-ground walking, they will know where and how the slip is going to occur and how to resist a fall. | Behavioural | observation |
Primary outcome
Fall incidence
Time frame: 1 year
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 16 May 2024.
- Derived from this study: PubMed 35237948Wang Y, Wang S, Liu X, Lee A, Pai YC, Bhatt T. Can a single session of treadmill-based slip training reduce daily life falls in community-dwelling older adults? A randomized controlled trial. Aging Clin Exp Res. 2022 Jul;34(7):1593-1602. doi: 10.1007/s40520-022-02090-3. Epub 2022 Mar 2.
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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.
Tanvi Bhatt, PhD principal investigator
University of Illinois 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 treadmill slip perturbation and observation training in people with Balance, Postural and Prevention, Accident, run by University of Illinois 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 1 inclusion and 2 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 16 May 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?
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: 1 year). 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 NCT02126488, which also lists 1 linked publication.
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 May 2024.