NCT01225432

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Last Updated

October 21, 2010

Status Verified

October 1, 2010

Enrollment Period

4.1 years

First QC Date

October 19, 2010

Last Update Submit

October 20, 2010

Conditions

Elevated Metabolic Cost

Outcome Measures

Primary Outcomes (4)

  • Gait Oxygen Consumption

    3 weeks

  • Gait Oxygen Consumption

    Immediately prior to start of 3 week training.

  • Gait Oxygen Consumption

    Immediately post training

  • Gait Oxygen Consumption

    3 weeks later from first post training testing

Study Arms (1)

Gait Training

EXPERIMENTAL
Other: Gait Training

Interventions

Gait TrainingOTHER

12 sessions, 30 minutes of walking on a treadmill with real time therapist directed feedback on gait kinematics.

Gait Training

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for the Intrepid

Fort Sam Houston, Texas, 78234, United States

Location

Study Officials

  • Jason M Wilken, PT, PhD

    Director, Military Performance Lab-Center for the Intrepid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

October 19, 2010

First Posted

October 21, 2010

Study Start

August 1, 2007

Primary Completion

September 1, 2011

Last Updated

October 21, 2010

Record last verified: 2010-10

Locations

US(1)