Traumatic Amputation Clinical Trial
Official title:
Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program
Verified date | October 2015 |
Source | University of Tennessee |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: 1. Unilateral trans-tibial amputee; 2. Military service member at the time of injury (Active Duty, Reserves or National Guard); 3. Age =18 and =55 years; and 4. Able to provide freely given informed consent. Exclusion Criteria: 1. 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; 2. Unable to speak and read English; 3. Implanted cardiac pacemaker or defibrillator; 4. 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); 5. Unwillingness to accept random assignment; 6. 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 7. 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. |
Country | Name | City | State |
---|---|---|---|
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
United States | University of Tennessee Health Science Center | Memphis | Tennessee |
United States | Navy Medical Center | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of Tennessee | United States Naval Medical Center, San Diego, Walter Reed National Military Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lower Extremity Muscle Strength- Extension | Muscle strength was measured with a handheld dynamometer for extensor knee strength of the residual and intact limb. | 0, 3, 6, 9, 12 wks | |
Primary | Lower Extremity Muscle Strength- Flexion | Muscle strength was measured with a handheld dynamometer for extensor and flexor knee strength of the residual and intact limb. | 0, 3, 6, 9, 12 wks | |
Primary | Lower Extremity Mobility-Distance | Mobility was measured by the distance walked in 2 minutes. | 6, 12 wks | |
Primary | Lower Extremity Mobility- Up and Go | Mobility was measured by the time to complete an "up and go" test. | 6, 12 wks | |
Primary | Lower Extremity Mobility- Stair Climb | Mobility was measured by the time to complete a timed stair climb. | 6, 12 wks | |
Primary | Lower Extremity Mobility-Chair Rise | Mobility was measured by the number of stands during the 30-second chair rise test. | 6, 12 wks | |
Secondary | Pain Severity | Pain severity was measured using a 4-item subscale of the Brief Pain Inventory. Pain is assessed at its "worst," "least," "average," and "current" level. Scores range from 0 (no pain) to 10 (pain, as bad as one can imagine). A mean pain score was calculated from the four items. | 0, 3, 6, 9, 12 wks | |
Secondary | Pain Interference | Pain interference was measured as how pain hindered daily activities: general activities, walking, work, mood, enjoyment of life, relations with others, and sleep using the Brief Pain Inventory. Participants rate each item on a scale from 0-10 (0=does not interfere; 10=completely interferes). The interference score represents the mean of the seven items. | 0, 3, 6, 9, 12 wks |
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