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

Elevated Metabolic Cost Clinical Trial

— VRVO2  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01225432
• Other study ID #: C.2008.050dt
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 19, 2010
• Last updated: October 20, 2010
• Start date: August 2007

Study information

• Verified date: October 2010
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 66
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elevated Metabolic Cost

Intervention

Other:
• Gait Training
12 sessions, 30 minutes of walking on a treadmill with real time therapist directed feedback on gait kinematics.

Locations

Country	Name	City	State
United States	Center for the Intrepid	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Oxygen Consumption		3 weeks	No
Primary	Gait Oxygen Consumption		Immediately prior to start of 3 week training.	No
Primary	Gait Oxygen Consumption		Immediately post training	No
Primary	Gait Oxygen Consumption		3 weeks later from first post training testing	No