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
  Purpose

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 Intervention Phase
Fall Prevention
Device: ActiveStep
Other: Standard Physical Therapy for Fall Prevention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized ActiveStep Clinical Evaluation

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

Primary Outcome Measures:
  • 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.


Enrollment: 65
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

Inclusion Criteria:

  • Age 65 or older
  • Referred for balance training

Exclusion Criteria:

  • Age < 65
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 The Dartmouth Institute for Health Policy & Clinical Practice
Principal Investigator: Richard M Greenwald, PhD Simbex Corporation
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00810082     History of Changes
Other Study ID Numbers: TDI001
Study First Received: December 16, 2008
Results First Received: October 24, 2011
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 16, 2014