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Randomized ActiveStep Clinical Evaluation (RACE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00810082
First Posted: December 17, 2008
Last Update Posted: March 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
Results First Submitted: October 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Fall Prevention
Interventions: Device: ActiveStep
Other: Standard Physical Therapy for Fall Prevention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from two sites, each a physical therapy clinic in a hospital setting.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Physical Therapy Only Physical therapy for fall prevention according to the clinician's standard practice.
Physical Therapy Incuding ActiveStep Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.

Participant Flow:   Overall Study
    Standard Physical Therapy Only   Physical Therapy Incuding ActiveStep
STARTED   34   31 
COMPLETED   34   27 
NOT COMPLETED   0   4 
Lost to Follow-up                0                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Physical Therapy Only Physical therapy for fall prevention according to the clinician's standard practice.
Physical Therapy Incuding ActiveStep Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
Total Total of all reporting groups

Baseline Measures
   Standard Physical Therapy Only   Physical Therapy Incuding ActiveStep   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   31   65 
Age 
[Units: Years]
Mean (Standard Deviation)
 79.2  (7.65)   81.1  (7.53)   80.5  (7.3) 
Gender 
[Units: Participants]
     
Female   23   14   37 
Male   11   17   28 
Region of Enrollment 
[Units: Participants]
     
United States   34   31   65 


  Outcome Measures

1.  Primary:   Participants With at Least One Fall   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Jon D. Lurie, MD, MS
Organization: Dartmouth College
phone: 603-653-3575
e-mail: Jonathan D. Lurie <Jonathan.D.Lurie@hitchcock.org>



Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00810082     History of Changes
Other Study ID Numbers: TDI001
First Submitted: December 16, 2008
First Posted: December 17, 2008
Results First Submitted: October 24, 2011
Results First Posted: March 26, 2012
Last Update Posted: March 26, 2012