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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Walter Reed National Military Medical Center
United States Naval Medical Center, San Diego
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT00942890
First received: July 15, 2009
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Traumatic Amputation
Device: NMES (EMPI 300PV stimulator) plus standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • lower extremity muscle strength and mobility [ Time Frame: Strength: 0, 3, 6-7, 9, 13 wks; Mobility 7, 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life and symptoms associated with residual limb and phantom pain [ Time Frame: QOL: 0, 7, 13 wks; Symptoms: 0, 3, 6-7, 9, 13 wks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard rehabilitation protocol
Both the control and treatment group will receive the standard rehabilitation protocol.
Device: NMES (EMPI 300PV stimulator) plus standard of care
In addition to the standard rehabilitation, the NMES treatment group will receive neuromuscular electrical stimulation to the quadriceps muscle of the residual and intact limb. The name of the NMES device is EMPI 300PV. NMES training will consist of performing 15 to 20 minute stimulation sessions with a 5-minute patient treatment log, 5 times per week for 12 weeks. During each training session, 15 NMES contractions per leg will be completed. Each contraction will be elicited by an electrical impulse (300PV) generated by a battery-operated device. This will be performed at home.
Other Name: EMPI 300PV neuromuscular stimulator
Experimental: NMES w/ rehab
In addition to the standard rehabilitation, the NMES treatment group will receive neuromuscular electrical stimulation to the quadriceps muscle of the residual and intact limb. This is the NMES w/rehabilitation
Device: NMES (EMPI 300PV stimulator) plus standard of care
In addition to the standard rehabilitation, the NMES treatment group will receive neuromuscular electrical stimulation to the quadriceps muscle of the residual and intact limb. The name of the NMES device is EMPI 300PV. NMES training will consist of performing 15 to 20 minute stimulation sessions with a 5-minute patient treatment log, 5 times per week for 12 weeks. During each training session, 15 NMES contractions per leg will be completed. Each contraction will be elicited by an electrical impulse (300PV) generated by a battery-operated device. This will be performed at home.
Other Name: EMPI 300PV neuromuscular stimulator

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 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 is neuromuscular electrical stimulation (NMES). The overall objectives of this study is to test two different approaches to prosthetic rehabilitation 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 rehabilitation program will have greater improvements in muscle strength and pain as compared to the standard rehabilitation protocol alone. The rationale for this study is that NMES could have an additive effect to the Walter Reed Army Medical Center (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 rehabilitation, 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 rehabilitation 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 Walter Reed Army Medical Center rehabilitation protocol. Generalized Estimating Equation 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 rehabilitation of amputees so they can achieve functional independence and regain lost muscle strength in preparation for return to duty.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942890

Locations
United States, California
Navy Medical Center
San Diego, California, United States, 92134
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
University of Tennessee
Walter Reed National Military Medical Center
United States Naval Medical Center, San Diego
Investigators
Principal Investigator: Laura A Talbot, PhD UTHSC
Principal Investigator: Michelle Kane, PhD Walter Reed National Military Medical Center
Principal Investigator: Michael Rosenthal, PhD Navy Medical Center, San Diego
  More Information

No publications provided

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT00942890     History of Changes
Other Study ID Numbers: TSNRP Grant HU0001-08-1-TS10
Study First Received: July 15, 2009
Last Updated: January 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
Case Management
Amputation
Muscle strength
phantom limb pain

Additional relevant MeSH terms:
Amputation, Traumatic
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014