NCT01621958

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

3.6 years

First QC Date

June 12, 2012

Last Update Submit

November 4, 2019

Conditions

Keywords

balance lossdynamic stabilitymotor learningplasticity

Outcome Measures

Primary Outcomes (1)

  • Fall incidence

    6 months

Secondary Outcomes (1)

  • Dynamic stability

    6 months

Study Arms (2)

Motor training

EXPERIMENTAL
Behavioral: Repeated perturbation training

Intensity control

PLACEBO COMPARATOR
Behavioral: Minimal perturbation training

Interventions

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.

Also known as: Repeated slip training
Motor training

One session consisting of a single slip exposure. Retest consisting of one slip exposure at either 6 months, 9 months or 12 months.

Also known as: Single slip exposure
Intensity control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • using any sedative of any type,
  • having known history of osteoporosis,
  • having any clinically significant functional impairment related to a specific musculoskeletal, neurological, or cardiopulmonary disease,
  • ultrasound calcaneus bone mineral density T score \< -1 (osteoporosis )
  • Mini-Mental State exam score \< 25 (impaired cognition),
  • timed up-and-go \> 13.5 sec (impaired mobility).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Gait and Movement Analysis Laboratory

Chicago, Illinois, 60612, United States

Location

Study Officials

  • Yi-Chung Pai, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 18, 2012

Study Start

September 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

November 6, 2019

Record last verified: 2019-11

Locations