ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized ActiveStep Clinical Evaluation (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.
ClinicalTrials.gov Identifier: NCT00810082
Recruitment Status : Completed
First Posted : December 17, 2008
Results First Posted : March 26, 2012
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief Summary:
The purpose of this study is to learn if using the ActiveStep™ treadmill reduces the number and severity of falls in older adults. This is a pilot study. The information collected will be used to support a grant application for a large multi-center trial in the future.

Condition or disease Intervention/treatment Phase
Fall Prevention Device: ActiveStep Other: Standard Physical Therapy for Fall Prevention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized ActiveStep Clinical Evaluation
Study Start Date : December 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Group A
Standard physical therapy for fall prevention
Other: Standard Physical Therapy for Fall Prevention
Standard physical therapy for fall prevention
Experimental: Group B
Physical therapy for fall prevention that includes ActiveStep
Device: ActiveStep
ActiveStep™ is a training simulator. The system uses a computer-controlled treadmill to recreate life-like dynamic balance challenges such as slipping and tripping in a safe, controlled environment.
Other: Standard Physical Therapy for Fall Prevention
Standard physical therapy for fall prevention



Primary Outcome Measures :
  1. Participants With at Least One Fall [ Time Frame: 3 months ]
    Subjects who had at least one fall subsequent to treatment.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Age 65 or older
  • Referred for balance training

Exclusion Criteria:

  • Age < 65

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 ClinicalTrials.gov identifier (NCT number): NCT00810082


Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Alice Peck Day Memorial Hospital
Lebanon, New Hampshire, United States, 03766
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Jon D Lurie, MD, MS Dartmouth College
Principal Investigator: Richard M Greenwald, PhD Simbex Corporation

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00810082     History of Changes
Other Study ID Numbers: TDI001
First Posted: December 17, 2008    Key Record Dates
Results First Posted: March 26, 2012
Last Update Posted: May 23, 2018
Last Verified: April 2018