Motor Training for Fall Prevention

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yi-Chung (Clive) Pai, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01621958
First received: June 12, 2012
Last updated: April 24, 2014
Last verified: April 2014
  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 Blind (Subject)
Primary Purpose: Prevention
Official Title: Motor Training for Fall Prevention: Adaptation and Retention in Older Adults

Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Fall incidence [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dynamic stability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621958

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

No publications provided

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
Study First Received: June 12, 2012
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Illinois at Chicago:
balance loss
dynamic stability
motor learning
plasticity

ClinicalTrials.gov processed this record on August 19, 2014