ActiveStep Comparative Effectiveness Trial (RACE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Dartmouth-Hitchcock Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jon D. Lurie, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01006967
First received: October 27, 2009
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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 Intervention
Gait Instability
Device: ActiveStep Treadmill
Other: Physical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized ActiveStep Comparative Effectiveness Trial

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Proportion of subjects reporting any fall [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first reported fall [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Number of injurious falls [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Changes in balance assessment scores pre- and post-treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: November 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01006967

Contacts
Contact: Alexandra Zagaria, BA 603-653-6125 alexandra.zagaria@dartmouth.edu
Contact: Judi Forman, MPH 603-653-6692 judith.l.forman@dartmouth.edu

Locations
United States, Massachusetts
Newton-Wellesley Hospital Recruiting
Newton, Massachusetts, United States, 02462
Contact: Kathy Gill-Body, PT    617-243-6172    kgillbody@mghihp.edu   
Contact: Theresa Jacobs, PT    617-243-6172    tljacobs@partners.org   
Principal Investigator: Kathy Gill-Body, PT         
Spaulding Rehabilitation Hospital Recruiting
Salem, Massachusetts, United States, 01970
Contact: Melissa Morse, PT    978-825-8566    mmorse6@partners.org   
Principal Investigator: Paolo Bonato, PhD         
United States, New Hampshire
Concord Hospital Rehabilitation Services Recruiting
Epsom, New Hampshire, United States, 03234
Contact: Melanie Bieniek, DPT, OCS    603-736-6222 ext 8735    mbieniek@crhc.org   
Principal Investigator: Melanie Bieniek, DPT, OCS         
Cheshire Medical Center - Farnum Rehabilitation Center Recruiting
Keene, New Hampshire, United States, 03431
Contact: Sharil Cass, PT    603-354-5454 ext 2912    SCass@Cheshire-Med.COM   
Principal Investigator: Sharil Cass, PT         
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Jane Prescott, B.A., CCRP    603-653-0766    Jane.A.Prescott@Dartmouth.edu   
Contact: Alexandria Zagaria, BA    603-653-0793    alexandra.zagaria@tdi.dartmouth.edu   
Principal Investigator: Dawna Pidgeon, PT         
The Elliot Hospital Recruiting
Manchester, New Hampshire, United States, 03104
Contact: Lisa Ellis       LEllis@Elliot-HS.org   
Principal Investigator: Lisa Ellis         
United States, New York
South Shore Neurological Associates Recruiting
Patchogue, New York, United States, 11722
Contact: Christina Burke, PT, MA    631-758-1910 ext 2173    cburke@southshoreneurologic.com   
Contact: Amanda Fortuna    631-758-1910    afortuna@southshoreneurologic.com   
Principal Investigator: Christina Burke, PT, MA         
United States, Vermont
White River Junction Veterans Administration Medical Center Terminated
White River Junction, Vermont, United States, 05009
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Jon D Lurie, M.D., M.S. The Dartmouth Institute for Health Policy & Clinical Practice
  More Information

No publications provided

Responsible Party: Jon D. Lurie, Associate Professor of Medicine (General Internal Medicine), Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01006967     History of Changes
Other Study ID Numbers: AHRQ R18 HS18459
Study First Received: October 27, 2009
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
balance
gait
physical therapy
ActiveStep

ClinicalTrials.gov processed this record on July 22, 2014