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Randomized ActiveStep Clinical Evaluation (RACE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00810082
First received: December 16, 2008
Last updated: February 21, 2012
Last verified: February 2012
History of Changes

December 16, 2008
February 21, 2012
December 2008
December 2009   (final data collection date for primary outcome measure)
Participants With at Least One Fall [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Subjects who had at least one fall subsequent to treatment.
The number of falls after balance training. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00810082 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Randomized ActiveStep Clinical Evaluation
Randomized ActiveStep Clinical Evaluation

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Fall Prevention
  • 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
  • Active Comparator: Group A
    Standard physical therapy for fall prevention
    Intervention: Other: Standard Physical Therapy for Fall Prevention
  • Experimental: Group B
    Physical therapy for fall prevention that includes ActiveStep
    Interventions:
    • Device: ActiveStep
    • Other: Standard Physical Therapy for Fall Prevention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 65 or older
  • Referred for balance training

Exclusion Criteria:

  • Age < 65
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00810082
TDI001
No
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Not Provided
Principal Investigator: Jon D Lurie, MD, MS The Dartmouth Institute for Health Policy & Clinical Practice
Principal Investigator: Richard M Greenwald, PhD Simbex Corporation
Dartmouth-Hitchcock Medical Center
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP