ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00942890
Recruitment Status : Completed
First Posted : July 21, 2009
Results First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Collaborators:
Walter Reed National Military Medical Center
United States Naval Medical Center, San Diego
Information provided by (Responsible Party):
University of Tennessee

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Traumatic Amputation
Interventions: Device: NMES (EMPI 300PV stimulator) plus standard of care
Behavioral: TMARP standard of care

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was a total of 44 participants.

Reporting Groups
  Description
Standard Rehabilitation Protocol The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 wk 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.
NMES Plus Standard Rehabilitation Protocol NMES (EMPI 300PV stimulator) plus TMARP 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.

Participant Flow:   Overall Study
    Standard Rehabilitation Protocol   NMES Plus Standard Rehabilitation Protocol
STARTED   21   23 
COMPLETED   21   23 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Rehabilitation Protocol 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. 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.
NMES Plus Standard Rehabilitation Protocol NMES (EMPI 300PV stimulator) plus TMARP 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.
Total Total of all reporting groups

Baseline Measures
   Standard Rehabilitation Protocol   NMES Plus Standard Rehabilitation Protocol   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   23   44 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      21 100.0%      23 100.0%      44 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.1  (6.3)   26.5  (5.9)   26.5  (5.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      1   4.3%      1   2.3% 
Male      21 100.0%      22  95.7%      43  97.7% 
Region of Enrollment 
[Units: Participants]
     
United States   21   23   44 


  Outcome Measures

1.  Primary:   Lower Extremity Muscle Strength- Extension   [ Time Frame: 0, 3, 6, 9, 12 wks ]

2.  Primary:   Lower Extremity Muscle Strength- Flexion   [ Time Frame: 0, 3, 6, 9, 12 wks ]

3.  Primary:   Lower Extremity Mobility-Distance   [ Time Frame: 6, 12 wks ]

4.  Primary:   Lower Extremity Mobility- Up and Go   [ Time Frame: 6, 12 wks ]

5.  Primary:   Lower Extremity Mobility- Stair Climb   [ Time Frame: 6, 12 wks ]

6.  Primary:   Lower Extremity Mobility-Chair Rise   [ Time Frame: 6, 12 wks ]

7.  Secondary:   Pain Severity   [ Time Frame: 0, 3, 6, 9, 12 wks ]

8.  Secondary:   Pain Interference   [ Time Frame: 0, 3, 6, 9, 12 wks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Laura Talbot
Organization: University of Tennessee Health Science Center
phone: 901-448-3630
e-mail: ltalbot@uthsc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT00942890     History of Changes
Other Study ID Numbers: TSNRP Grant HU0001-08-1-TS10
First Submitted: July 15, 2009
First Posted: July 21, 2009
Results First Submitted: October 11, 2016
Results First Posted: April 10, 2018
Last Update Posted: April 10, 2018