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
Results First Received: October 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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  
Number of Participants  
[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
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  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>


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