- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02126488
Effect of Adaptive Training for Balance Recovery
July 14, 2021 updated by: Tanvi Bhatt, University of Illinois at Chicago
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
308
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60612
- Clinical Gait and Movement Analysis Laboratory
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Ultrasound calcaneus bone mineral density T score < -2.5 (osteoporotic)
- Mini-Mental State exam score < 25 (cognitive impairment)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treadmill perturbation
treadmill slip perturbation
|
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.
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Placebo Comparator: treadmill placebo
treadmill training placebo
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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.
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Sham Comparator: observation
observation training
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fall incidence
Time Frame: 1 year
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dynamic stability
Time Frame: 6 months
|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
April 25, 2014
First Submitted That Met QC Criteria
April 29, 2014
First Posted (Estimate)
April 30, 2014
Study Record Updates
Last Update Posted (Actual)
July 16, 2021
Last Update Submitted That Met QC Criteria
July 14, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2000-0788
- R01AG044364 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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