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The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation (VRVO2)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT01225432
First received: October 19, 2010
Last updated: October 20, 2010
Last verified: October 2010

October 19, 2010
October 20, 2010
August 2007
September 2011   (final data collection date for primary outcome measure)
  • Gait Oxygen Consumption [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Gait Oxygen Consumption [ Time Frame: Immediately prior to start of 3 week training. ] [ Designated as safety issue: No ]
  • Gait Oxygen Consumption [ Time Frame: Immediately post training ] [ Designated as safety issue: No ]
  • Gait Oxygen Consumption [ Time Frame: 3 weeks later from first post training testing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01225432 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation
The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation

To assess the carryover effect of an innovative new gait training program on physiological and functional gait performance in persons with a traumatic lower extremity amputation. A second objective is to clarify the relationship between gait biomechanics (joint and sgment kinematics and energy cost.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Elevated Metabolic Cost
Other: Gait Training
12 sessions, 30 minutes of walking on a treadmill with real time therapist directed feedback on gait kinematics.
Experimental: Gait Training
Intervention: Other: Gait Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
66
Not Provided
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Unilateral traumatic trans-tibial or transfemoral amputation
  • Independent ambulation without an assistive device for a minimum of three months
  • Ability to ambulate continuously for a minimum of 15 minutes
  • Trans-femoral participants must use an ischial containment socket
  • VAS Pain scores on the involved side of less than 4/10
  • Sagittal plane ankle, knee and hip strength of 4 or greater on the uninvolved side as determined by manual muscle test.

Exclusion Criteria:

  • Blindness
  • TBI-Glascow Coma Scale score of 12 or lower at the time of injury
  • Cardiac or pulmonary problems limiting physical activity PTSD or other psychological condition with symptoms that would be exacerbated by participation in the study.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01225432
C.2008.050dt
No
Jason M. Wilken PT, PhD, Brooke Army Medical Center
Brooke Army Medical Center
Not Provided
Principal Investigator: Jason M Wilken, PT, PhD Director, Military Performance Lab-Center for the Intrepid
Brooke Army Medical Center
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP