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
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: 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 August 01, 2014