RapidRehab: Improved Training Program for Fall Prevention of War Fighters

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT03446131

Collaborator

United States Naval Medical Center, San Diego (U.S. Fed), Walter Reed National Military Medical Center (U.S. Fed), Brooke Army Medical Center (U.S. Fed), University of Illinois at Chicago (Other)

Enrollment

Locations

33.7

Actual Duration (Months)

11.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will train War Fighters with lower extremity trauma to decrease fall risk.

Condition or Disease	Intervention/Treatment	Phase
Limb Injury

Detailed Description

Eligible active duty service members, retired or veterans who participated in rehabilitation programs at Department of Defense Advanced Rehabilitation Centers (Walter Reed National Military Medical Center, Center for the Intrepid-San Antonio Military Medical Center and/or the Naval Medical Center San Diego) will be considered for enrollment in this study. This study will look at service members who have undergone transfemoral, transtibial or bilateral lower extremity amputation or limb salvage procedures. Participants will receive fall prevention training on an instrumented treadmill (6, training sessions). Participants will receive three performance assessments:-immediately following completion of the treadmill training and at three and six months following the completion of the training. Post training, twice per month subjects will receive an email containing a follow up fall questionnaire monitoring if they have fallen and the circumstances surrounding their fall. If they do not have access to email, or if a timely response is not received from the email questionnaire which was sent out, subjects will be contacted by phone.

Study Design

Study Type:

Observational

Actual Enrollment :

45 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Improved Training Program for Fall Prevention of War Fighters With Lower Extremity Trauma

Actual Study Start Date :

Mar 12, 2018

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

Change in Trunk Position [Change from baseline at 0, 3, and 6 months after completing training]
Trunk Position (referenced to vertical) at recovery step completion
Change in Trunk Velocity [Change from baseline at 0, 3, and 6 months after completing training]
Trunk Velocity at recovery step completion

Secondary Outcome Measures

Falls [Change from baseline at 0, 3, and 6 months after completing training]
Falls per month reported in the Prosthesis Evaluation Questionnaire - Addendum
FSST [Change from baseline at 0, 3, and 6 months after completing training]
Four-Square Step Test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Eligible active duty and retired service members and veterans with lower limb trauma
Transfemoral amputation, transtibial amputation, bilateral amputation and or limb salvage
Participated in conventional rehab at one of the following rehab centers: Walter Reed National Medical Center, Center for the Intrepid Brooke Army Medical Center, Naval Medical Center San Diego
Community ambulator
Prosthesis / Orthosis use daily
Exclusion Criteria:
Dysvascular disease
Excessive pain
Neuromuscular problems preventing the performance of study protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Naval Medical Center San Diego	San Diego	California	United States	92134
2	Walter Reed National Military Medical Center	Bethesda	Maryland	United States	20889
3	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905
4	Center for the Intrepid Brooke Army Medical Center	San Antonio	Texas	United States	78234