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Randomized ActiveStep Clinical Evaluation (RACE)

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ClinicalTrials.gov Identifier: NCT00810082
Recruitment Status : Completed
First Posted : December 17, 2008
Results First Posted : March 26, 2012
Last Update Posted : March 26, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Phase 4

Study Design

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
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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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
Contacts and Locations

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
More Information

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: March 26, 2012
Last Verified: February 2012