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Effect of Adaptive Training for Balance Recovery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Yi-Chung (Clive) Pai, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT02126488
First received: April 25, 2014
Last updated: September 27, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Balance, Postural Prevention, Accident Behavioral: treadmill slip perturbation Behavioral: treadmill training placebo Behavioral: observation training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Perturbation Training for Fall-risk Reduction Among 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: 1 year ]

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: 308
Study Start Date: June 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treadmill perturbation
treadmill slip perturbation
Behavioral: 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.
Placebo Comparator: treadmill placebo
treadmill training placebo
Behavioral: treadmill training placebo
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.
Sham Comparator: observation
observation training
Behavioral: 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.

  Eligibility

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.

Exclusion Criteria:

  • Ultrasound calcaneus bone mineral density T score < -2.5 (osteoporotic)
  • Mini-Mental State exam score < 25 (cognitive impairment)
  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: NCT02126488

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: NCT02126488     History of Changes
Other Study ID Numbers: 2013-04798
R01AG044364 ( U.S. NIH Grant/Contract )
Study First Received: April 25, 2014
Last Updated: September 27, 2016

Keywords provided by Yi-Chung (Clive) Pai, University of Illinois at Chicago:
treadmill training
generalization
retention

ClinicalTrials.gov processed this record on September 19, 2017