Traumatic AmputationNCT00942890
Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program
A study of Traumatic Amputation, run by University of Tennessee at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Traumatic Amputation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2009to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Navy Medical Center
San Diego, California, 92134
About this study
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.
Read the 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.
- Conditions
- Traumatic Amputation
- Being tested
- NMES (EMPI 300PV stimulator) plus standard of care, TMARP standard of care
- Keywords
- Case Management, Amputation, Muscle strength, phantom limb pain
- Medical subject headings
- Amputation, Traumatic, Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMES (EMPI 300PV stimulator) plus standard of careDevice
Also called EMPI 300PV neuromuscular stimulator
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.
TMARP standard of careBehavioural
Also called Traditional Military Amputee Rehabilitation Program
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: TMARP standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Muscle Strength- Extension
Muscle strength was measured with a handheld dynamometer for extensor knee strength of the residual and intact limb.
Measured: 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.
Measured: 0, 3, 6, 9, 12 wks
Lower Extremity Mobility-Distance
Mobility was measured by the distance walked in 2 minutes.
Measured: 6, 12 wks
Lower Extremity Mobility- Up and Go
Mobility was measured by the time to complete an "up and go" test.
Measured: 6, 12 wks
Lower Extremity Mobility- Stair Climb
Mobility was measured by the time to complete a timed stair climb.
Measured: 6, 12 wks
Lower Extremity Mobility-Chair Rise
Mobility was measured by the number of stands during the 30-second chair rise test.
Measured: 6, 12 wks
Secondary outcomes (2)
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.
Measured: 0, 3, 6, 9, 12 wks
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.
Measured: 0, 3, 6, 9, 12 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed National Military Medical Center, United States Naval Medical Center, San Diego
- Responsible party
- Sponsor
- Investigators
- Laura A Talbot, PhD, Principal investigator, UTHSCMichelle Kane, PhD, Principal investigator, Walter Reed National Military Medical CenterMichael Rosenthal, PhD, Principal investigator, Navy Medical Center San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942890
- Sponsor's protocol ID
- TSNRP Grant HU0001-08-1-TS10
- Status last verified
- Oct 2015
- First submitted
- 15 Jul 2009
- Last updated
- 10 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28830632Talbot 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.
PubMed 28051969
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program
- ClinicalTrials.gov ID
- NCT00942890
- Acronym / sponsor ID
- TSNRP Grant HU0001-08-1-TS10
- Conditions
- Traumatic Amputation
- Keywords
- Case Management, Amputation, Muscle strength, phantom limb pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Walter Reed National Military Medical Center, United States Naval Medical Center, San Diego
- Study start
- Apr 2009
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Jul 2009 (estimated)
- Results
- Posted 10 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES plus Standard Rehab Protocol | Experimental | Device: NMES (EMPI 300PV stimulator) plus standard of careNMES (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. |
| Standard Rehab Protocol | Active comparator | Behavioral: TMARP standard of careTMARP 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMES (EMPI 300PV stimulator) plus standard of careAlso: EMPI 300PV neuromuscular stimulatorIn 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. | Device | NMES plus Standard Rehab Protocol |
| TMARP standard of careAlso: Traditional Military Amputee Rehabilitation ProgramThe 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. | Behavioural | Standard Rehab Protocol |
Primary outcome
Lower Extremity Muscle Strength- Extension
Time frame: 0, 3, 6, 9, 12 wks
Muscle strength was measured with a handheld dynamometer for extensor knee strength of the residual and intact limb.
Lower Extremity Muscle Strength- Flexion
Time frame: 0, 3, 6, 9, 12 wks
Muscle strength was measured with a handheld dynamometer for extensor and flexor knee strength of the residual and intact limb.
Lower Extremity Mobility-Distance
Time frame: 6, 12 wks
Mobility was measured by the distance walked in 2 minutes.
Lower Extremity Mobility- Up and Go
Time frame: 6, 12 wks
Mobility was measured by the time to complete an "up and go" test.
Lower Extremity Mobility- Stair Climb
Time frame: 6, 12 wks
Mobility was measured by the time to complete a timed stair climb.
Lower Extremity Mobility-Chair Rise
Time frame: 6, 12 wks
Mobility was measured by the number of stands during the 30-second chair rise test.
2 secondary outcomes
Pain Severity
Time frame: 0, 3, 6, 9, 12 wks
Pain Interference
Time frame: 0, 3, 6, 9, 12 wks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28830632Talbot 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.
- Derived from this study: PubMed 28051969Talbot 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura A Talbot, PhD principal investigator
UTHSC
Michelle Kane, PhD principal investigator
Walter Reed National Military Medical Center
Michael Rosenthal, PhD principal investigator
Navy Medical Center San Diego
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Traumatic Amputation, run by University of Tennessee at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Extremity Muscle Strength- Extension (time frame: 0, 3, 6, 9, 12 wks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00942890, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018; AzTrials last refreshed its copy on 31 Oct 2026.