Randomized ActiveStep Clinical Evaluation - Full Text View

Randomized ActiveStep Clinical Evaluation (RACE)

This study is currently recruiting participants.

Verified by Dartmouth-Hitchcock Medical Center, January 2009

First Received: December 16, 2008 Last Updated: January 30, 2009 History of Changes

Sponsored by:	Dartmouth-Hitchcock Medical Center
Information provided by:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00810082

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 IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized ActiveStep Clinical Evaluation

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

Primary Outcome Measures:

The number of falls after balance training. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	December 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Active Comparator Standard physical therapy for fall prevention	Other: Standard Physical Therapy for Fall Prevention Standard physical therapy for fall prevention
Group B: Experimental 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

Contacts

Contact: Judith L Forman, MPH

603-653-0736

Judith.L.Forman@dartmouth.edu

Locations

United States, New Hampshire
Dartmouth-Hitchcock Medical Center	Recruiting
Lebanon, New Hampshire, United States, 03756
Alice Peck Day Memorial Hospital	Recruiting
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 College ( Jon D. Lurie, MD, MS )
Study ID Numbers:	TDI001
Study First Received:	December 16, 2008
Last Updated:	January 30, 2009
ClinicalTrials.gov Identifier:	NCT00810082 History of Changes
Health Authority:	United States: Dartmouth College Commitee for the Protection of Human Subjects

ClinicalTrials.gov processed this record on May 07, 2009