Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program

Completed · Not applicable

Conditions studied: Traumatic Amputation

In brief

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 current standard of care in preserving thigh muscle strength. In addition, this study will examine the NMES treatment effects on the participant's gait, quality of life, functional performance of standing, walking, and stair climbing, and symptoms associated with residual and phantom limb pain. The primary aim is to compare NMES plus standard rehabilitation (treatment group) to the standard rehabilitation (control group) by measuring lower extremity muscle strength. The secondary aims are to compare NMES treatment group to the control group by measuring Quality of Life (QOL) and the symptoms associated with residual \& phantom limb pain. In addition to the specific aims, this study will also examine the two groups for functional performance and gait patterns after prosthetic fitting.

Key facts

Study ID

NCT00942890

Run by

University of Tennessee

People needed

44

Starts

2009-04-01

Expected to finish

2015-08-01

Last updated by the study team

2018-04-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Navy Medical Center — San Diego, California, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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