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

NCT00942890 | Completed Results DMC

• 1 other identifier: TSNRP Grant HU0001-08-1-TS10
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Traumatic Amputation

Keywords

Case Management; Amputation; Muscle strength; phantom limb pain

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• Lower Extremity Mobility-Distance

  Mobility was measured by the distance walked in 2 minutes.

  6, 12 wks

• Lower Extremity Mobility- Up and Go

  Mobility was measured by the time to complete an "up and go" test.

  6, 12 wks

• Lower Extremity Mobility- Stair Climb

  Mobility was measured by the time to complete a timed stair climb.

  6, 12 wks

• Lower Extremity Mobility-Chair Rise

  Mobility was measured by the number of stands during the 30-second chair rise test.

  6, 12 wks

Secondary Outcomes (2)

• Pain Severity

  0, 3, 6, 9, 12 wks

• Pain Interference

  0, 3, 6, 9, 12 wks

Study Arms (2)

NMES plus Standard Rehab Protocol

EXPERIMENTAL

NMES (EMPI 300PV stimulator) plus standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3" X 5" electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits.

Device: NMES (EMPI 300PV stimulator) plus standard of care

Standard Rehab Protocol

ACTIVE COMPARATOR

TMARP standard of care intervention: 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks, preparing for the prosthetic. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.

Behavioral: TMARP standard of care

Interventions

NMES (EMPI 300PV stimulator) plus standard of care DEVICE

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.

Also known as: EMPI 300PV neuromuscular stimulator

NMES plus Standard Rehab Protocol

TMARP standard of care BEHAVIORAL

The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks, preparing for the prosthetic. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.

Also known as: Traditional Military Amputee Rehabilitation Program

Standard Rehab Protocol

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• University of Tennessee: lead
• Walter Reed National Military Medical Center: collaborator
• United States Naval Medical Center, San Diego: collaborator

Study Sites (3)

Navy Medical Center

San Diego, California, 92134, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Related Publications (2)

• Talbot LA, Brede E, Price M, Metter EJ. Health-related quality of life in active duty military: A secondary data analysis of two randomized controlled trials. Nurs Outlook. 2017 Sep-Oct;65(5S):S53-S60. doi: 10.1016/j.outlook.2017.07.010. Epub 2017 Jul 25.

  PMID: 28830632 DERIVED

• Talbot LA, Brede E, Metter EJ. Effects of Adding Neuromuscular Electrical Stimulation to Traditional Military Amputee Rehabilitation. Mil Med. 2017 Jan;182(1):e1528-e1535. doi: 10.7205/MILMED-D-16-00037.

  PMID: 28051969 DERIVED

MeSH Terms

Conditions

Amputation, Traumatic; Phantom Limb

Condition Hierarchy (Ancestors)

Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Limitations and Caveats

The limitations of the the study was that it was not powered to detect a small or moderate difference between the two treatment groups. The sample was small and limited to military service members.

Results Point of Contact

• Title: Dr. Laura Talbot
• Organization: University of Tennessee Health Science Center

ltalbot@uthsc.edu

901-448-3630

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 21, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 10, 2018
• Results First Posted: April 10, 2018

Record last verified: 2015-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)