Amputee Gait Training Using Virtual Reality and Real-Time... | NCT01225120

Studies
Amputee Gait Training Using Virtual Reality and Real-Time Feedback

NCT01225120

Sponsor

Brooke Army Medical Center

Status

Unknown status

Last Update Posted

Oct 20, 2010Estimated

Enrollment

66Estimated

Phase

Not Applicable

Conditions

Abnormal Gait Kinematics

Interventions

Gait Training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Sep 2011Estimated

Completion Date

Not provided

First Submitted Date

Oct 19, 2010

First Submission Date that Met QC Criteria

Oct 19, 2010

First Posted Date

Oct 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2010

Last Update Posted Date

Oct 20, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gait Training	Experimental		Other: Gait Training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gait Training	Other	12 sessions, 30 minutes of walking on treadmill with real time therapist directed feedback on gait kinematics.	Gait Training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gait Biomechanics		3 weeks
Gait Biomechanics		immediately prior to start of 3 week training
Gait Biomechanics		Immediately post training
Gait Biomechanics		3 weeks from initial post training

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jason M Wilken, PT, PhD	Director, Military Performance Lab-Center for the Intrepid	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for the Intrepid		Fort Sam Houston	Texas	78234	United States