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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01225120
Other study ID # C.2007.072t
Secondary ID
Status Enrolling by invitation
Phase N/A
First received October 19, 2010
Last updated October 19, 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

The purpose of this repeated measures design gait training study is to develop and quantitatively assess the effectiveness of a virtual reality training environment using real-time feedback for modification of pelvic motion during gait.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 66
Est. completion date
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


Intervention

Other:
Gait Training
12 sessions, 30 minutes of walking on 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 Biomechanics 3 weeks No
Primary Gait Biomechanics immediately prior to start of 3 week training No
Primary Gait Biomechanics Immediately post training No
Primary Gait Biomechanics 3 weeks from initial post training No