View Clinical Trial (Medical Research Study)
Strength, Pain and Function in OIF/OEF Amputees: A Nurse-Managed Program
| City: |
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Charlotte |
| State: |
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North Carolina |
| Zip Code: |
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28223 |
| Conditions: |
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Transtibial Amputation |
| Purpose: |
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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.
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| Study Summary: |
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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 reductions in thigh muscle strength of the amputated limb during the
first year after amputation. The residual limb is less active in daily functions of standing
and walking, resulting in progressive atrophy of the quadriceps muscles in terms of a
decrease in thigh diameter which is estimated at 25% of pre-amputation diameter. An
intervention that may be useful in TTA rehabilitation (rehab) is neuromuscular electrical
stimulation (NMES). The overall objectives of this study is to test two different approaches
to prosthetic rehab as potential treatments for improving muscle strength, pain and
functional performance of daily activities in military personnel with TTA. Our central
hypothesis is that a Nurse Managed NMES Rehab Program will have greater improvements in
muscle strength and pain as compared to the standard rehab protocol alone. The rationale for
this study is that NMES could have an additive effect to the WRAMC standard of care program
with greater improvements in muscle strength thus enhancing the performance of daily
activities, Quality of Life (QOL), and decreasing disability. Such outcomes will ultimately
result in decreased economic costs, accelerated rehab, and potentially increase the
possibility of these warriors returning to duty. The specific aims are to test Nurse Managed
NMES relative to standard rehabilitation by comparing: (1) Lower extremity muscle strength;
(2) QOL; and (3) Symptoms associated with phantom pain. In addition to the above aims,
specific aims for the post prosthetic phase of the intervention are to compare the two
groups for (4) functional performance of daily activities. After pre-testing, participants
aged 18 to 55 yrs with a traumatic TTA will be randomly assigned to either the 1) Nurse
Managed NMES Rehab Program (n=30); or 2) WRAMC Amputee Protocol (n=30). Those in the NMES
group will receive 12 weeks of electrical muscle stimulation 15 min/day, 5 days a week for
12 weeks. Both groups will receive the standard 12-week WRAMC rehab protocol. GEE methods
will be used to build regression models for statistical analysis of the longitudinal data.
The significance of this research is that Nurse Managed NMES may be very important for
accelerating the rehab of amputees so they can achieve functional independence and regain
lost muscle strength in preparation for return to duty.
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| Criteria: |
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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 Glascow
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.
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| NCT ID: |
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NCT00942890 |
| Primary Contact: |
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Principal Investigator
Laura A Talbot, PhD
University of North Carolina, Charlotte
Laura A Talbot, PhD
Phone: 704-687-8348
Email: ltalbot@uncc.edu
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| Backup Contact: |
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Email: Sara.Sproat@us.army.mil
Sara Breckenridge-sproat, PhD
Phone: 202-782-7026
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| Location Contact: |
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Charlotte, North Carolina 28223
United States
Laura A Talbot, PhD
Phone: 704-687-8348
Email: ltalbot@uncc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 17, 2013 |
| Modifications to this listing: |
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