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Motor Training for Fall Prevention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01621958
First Posted: June 18, 2012
Last Update Posted: April 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Yi-Chung (Clive) Pai, University of Illinois at Chicago
  Purpose
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.

Condition Intervention
Fall Prevention Behavioral: Repeated perturbation training Behavioral: Minimal perturbation training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Motor Training for Fall Prevention: Adaptation and Retention in Older Adults

Resource links provided by NLM:


Further study details as provided by Yi-Chung (Clive) Pai, University of Illinois at Chicago:

Primary Outcome Measures:
  • Fall incidence [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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.


Enrollment: 212
Study Start Date: September 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motor training Behavioral: Repeated perturbation 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.
Other Name: Repeated slip training
Placebo Comparator: Intensity control Behavioral: Minimal perturbation training
One session consisting of a single slip exposure. Retest consisting of one slip exposure at either 6 months, 9 months or 12 months.
Other Name: Single slip exposure

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  • 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.

Exclusion Criteria:

The exclusion criteria include the following:

  1. using any sedative of any type,
  2. having known history of osteoporosis,
  3. having any clinically significant functional impairment related to a specific musculoskeletal, neurological, or cardiopulmonary disease,
  4. ultrasound calcaneus bone mineral density T score < -1 (osteoporosis )
  5. Mini-Mental State exam score < 25 (impaired cognition),
  6. timed up-and-go > 13.5 sec (impaired mobility).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621958


Locations
United States, Illinois
Clinical Gait and Movement Analysis Laboratory
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
National Institute on Aging (NIA)
Investigators
Principal Investigator: Yi-Chung Pai, PhD University of Illinois at Chicago
  More Information

Responsible Party: Yi-Chung (Clive) Pai, Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01621958     History of Changes
Other Study ID Numbers: 2008-02052
5R01AG029616-03 ( U.S. NIH Grant/Contract )
First Submitted: June 12, 2012
First Posted: June 18, 2012
Last Update Posted: April 28, 2014
Last Verified: April 2014

Keywords provided by Yi-Chung (Clive) Pai, University of Illinois at Chicago:
balance loss
dynamic stability
motor learning
plasticity