ActiveStep Comparative Effectiveness Trial (RACE)

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. Identifier: NCT01006967
Recruitment Status : Unknown
Verified January 2016 by Dartmouth-Hitchcock Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : November 3, 2009
Last Update Posted : January 22, 2016
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief Summary:

The investigators are conducting a multi-central randomized prospective trial comparing a standard physical therapy gait and balance program with a gait and balance program that includes the ActiveStep™ treadmill.

Subjects will be randomized to either have the ActiveStep™ as part of their therapy or to have their therapy without it. Data will be gathered from session notes, medical records and short interviews with the subjects at baseline and every 3 months over the telephone for the duration of the study.

Condition or disease Intervention/treatment Phase
Gait Instability Device: ActiveStep Treadmill Other: Physical Therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 507 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized ActiveStep Comparative Effectiveness Trial
Study Start Date : November 2009
Actual Primary Completion Date : July 2015
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Active Comparator: ActiveStep
Subjects will use the ActiveStep treadmill as part of their physical therapy program for balance
Device: ActiveStep Treadmill
The ActiveStep treadmill is a device that trains patients to effectively react to simulated slips and trips while the patient is safely held in a harness.

Active Comparator: Standard physical therapy
Subjects will receive a standard physical therapy program for gait and balance.
Other: Physical Therapy
Standard program of physical therapy for gait and balance

Primary Outcome Measures :
  1. Proportion of subjects reporting any fall [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Time to first reported fall [ Time Frame: length of study ]
  2. Number of injurious falls [ Time Frame: 1 year ]
  3. Changes in balance assessment scores pre- and post-treatment [ Time Frame: 3 months ]

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 65 and over
  • Referred to physical therapy for balance training

Exclusion Criteria:

  • Age < 65
  • Unable to use treadmill
  • Severe vertigo
  • Not a candidate for gait/balance PT
  • Not competent to consent to research

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 identifier (NCT number): NCT01006967

United States, Massachusetts
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
Spaulding Rehabilitation Hospital
Salem, Massachusetts, United States, 01970
United States, New Hampshire
Concord Hospital Rehabilitation Services
Epsom, New Hampshire, United States, 03234
Cheshire Medical Center - Farnum Rehabilitation Center
Keene, New Hampshire, United States, 03431
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
The Elliot Hospital
Manchester, New Hampshire, United States, 03104
United States, New York
South Shore Neurological Associates
Patchogue, New York, United States, 11722
United States, Vermont
White River Junction Veterans Administration Medical Center
White River Junction, Vermont, United States, 05009
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Jon D Lurie, M.D., M.S. Dartmouth College

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT01006967     History of Changes
Other Study ID Numbers: AHRQ R18 HS18459
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016

Keywords provided by Dartmouth-Hitchcock Medical Center:
physical therapy