Status:
COMPLETED
Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program
Lead Sponsor:
University of Tennessee
Collaborating Sponsors:
Walter Reed National Military Medical Center
United States Naval Medical Center, San Diego
Conditions:
Traumatic Amputation
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The purpose of this randomized control study is to determine if administering neuromuscular electrical stimulation (NMES) to the thigh muscles of a below the knee amputee is more effective than the cu...
Detailed Description
Traumatic amputation is one of the major injuries seen as a result of Operation Iraqi and Enduring Freedom with the majority being single trans-tibial amputations (TTA). TTA experience significant red...
Eligibility Criteria
Inclusion
- Unilateral trans-tibial amputee;
- Military service member at the time of injury (Active Duty, Reserves or National Guard);
- Age ≥18 and ≤55 years; and
- Able to provide freely given informed consent.
Exclusion
- A significant co-morbid medical condition (such as severe uncontrolled hypertension (over 160/100 mmHg) or neurological disorders such as epilepsy) where NMES strength training is contraindicated and/or participation would pose a safety threat or impair their ability to participate;
- Unable to speak and read English;
- Implanted cardiac pacemaker or defibrillator;
- Vision impairment where participant is classified as legally blind (we define legally blind both clinically and functionally. Clinically, it is central visual acuity of 20/200 or less in the better eye with corrective glasses. Functionally, the participant is not able to see the digital numbers on the NMES device with corrective glasses);
- Unwillingness to accept random assignment;
- Currently participating in another research study with an intervention that would potentially confound the outcome variables of this study (we will also instruct participants that joining a study after being enrolled in this protocol is also not allowed); and
- Conflicting co-morbidities including traumatic brain injury (score \< 14 on glasgow coma scale), and a contralateral lower extremity injury that causes antalgic gait, pain \> 5/10 consistently on the contralateral limb and/or a grade of \< 4+/5 in lower extremity.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00942890
Start Date
April 1 2009
End Date
August 1 2015
Last Update
April 10 2018
Active Locations (3)
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1
Navy Medical Center
San Diego, California, United States, 92134
2
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
3
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163