Trial Outcomes & Findings for Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program (NCT NCT00942890)
NCT ID: NCT00942890
Last Updated: 2018-04-10
Results Overview
Muscle strength was measured with a handheld dynamometer for extensor knee strength of the residual and intact limb.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
0, 3, 6, 9, 12 wks
Results posted on
2018-04-10
Participant Flow
There was a total of 44 participants.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
23
|
|
Overall Study
COMPLETED
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program
Baseline characteristics by cohort
| Measure |
Standard Rehabilitation Protocol
n=21 Participants
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
n=23 Participants
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
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
26.5 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
26.5 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
23 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 3, 6, 9, 12 wksMuscle strength was measured with a handheld dynamometer for extensor knee strength of the residual and intact limb.
Outcome measures
| Measure |
Standard Rehabilitation Protocol
n=21 Participants
The usual care is 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. 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
n=23 Participants
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.
|
|---|---|---|
|
Lower Extremity Muscle Strength- Extension
Intact Limb: Week 6
|
45.0 Kilograms
Standard Deviation 19.5
|
45.2 Kilograms
Standard Deviation 13.7
|
|
Lower Extremity Muscle Strength- Extension
Intact Limb: Week 9
|
46.0 Kilograms
Standard Deviation 16.7
|
45.7 Kilograms
Standard Deviation 16.1
|
|
Lower Extremity Muscle Strength- Extension
Intact Limb: Week 12
|
49.0 Kilograms
Standard Deviation 20.7
|
51.8 Kilograms
Standard Deviation 16.6
|
|
Lower Extremity Muscle Strength- Extension
Residual Limb: Week 0
|
24.5 Kilograms
Standard Deviation 10.7
|
26.4 Kilograms
Standard Deviation 13.4
|
|
Lower Extremity Muscle Strength- Extension
Residual Limb: Week 3
|
27.6 Kilograms
Standard Deviation 12.5
|
34.1 Kilograms
Standard Deviation 12.7
|
|
Lower Extremity Muscle Strength- Extension
Residual Limb: Week 6
|
33.8 Kilograms
Standard Deviation 17.3
|
36.9 Kilograms
Standard Deviation 12.6
|
|
Lower Extremity Muscle Strength- Extension
Residual Limb: Week 9
|
35.7 Kilograms
Standard Deviation 14.0
|
39.1 Kilograms
Standard Deviation 16.5
|
|
Lower Extremity Muscle Strength- Extension
Residual Limb: Week 12
|
36.1 Kilograms
Standard Deviation 15.4
|
42.8 Kilograms
Standard Deviation 14.8
|
|
Lower Extremity Muscle Strength- Extension
Intact Limb: Week 0
|
45.7 Kilograms
Standard Deviation 23.8
|
45.4 Kilograms
Standard Deviation 17.6
|
|
Lower Extremity Muscle Strength- Extension
Intact Limb: Week 3
|
45.2 Kilograms
Standard Deviation 24.3
|
41.4 Kilograms
Standard Deviation 16.1
|
PRIMARY outcome
Timeframe: 0, 3, 6, 9, 12 wksMuscle strength was measured with a handheld dynamometer for extensor and flexor knee strength of the residual and intact limb.
Outcome measures
| Measure |
Standard Rehabilitation Protocol
n=21 Participants
The usual care is 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. 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
n=23 Participants
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.
|
|---|---|---|
|
Lower Extremity Muscle Strength- Flexion
Residual Limb: Week 0
|
14.8 Kilograms
Standard Deviation 8.5
|
14.2 Kilograms
Standard Deviation 6.2
|
|
Lower Extremity Muscle Strength- Flexion
Residual Limb: Week 3
|
14.8 Kilograms
Standard Deviation 7.4
|
16.7 Kilograms
Standard Deviation 7.0
|
|
Lower Extremity Muscle Strength- Flexion
Residual Limb: Week 6
|
16.8 Kilograms
Standard Deviation 7.3
|
18.7 Kilograms
Standard Deviation 6.9
|
|
Lower Extremity Muscle Strength- Flexion
Residual Limb: Week 9
|
18.4 Kilograms
Standard Deviation 7.5
|
19.9 Kilograms
Standard Deviation 7.6
|
|
Lower Extremity Muscle Strength- Flexion
Residual Limb: Week 12
|
19.5 Kilograms
Standard Deviation 8.4
|
21.8 Kilograms
Standard Deviation 6.6
|
|
Lower Extremity Muscle Strength- Flexion
Intact Limb: Week 0
|
25.4 Kilograms
Standard Deviation 7.1
|
27.8 Kilograms
Standard Deviation 10.7
|
|
Lower Extremity Muscle Strength- Flexion
Intact Limb: Week 3
|
27.1 Kilograms
Standard Deviation 10.2
|
28.7 Kilograms
Standard Deviation 9.4
|
|
Lower Extremity Muscle Strength- Flexion
Intact Limb: Week 6
|
26.9 Kilograms
Standard Deviation 10.9
|
32.2 Kilograms
Standard Deviation 10.3
|
|
Lower Extremity Muscle Strength- Flexion
Intact Limb: Week 9
|
28.8 Kilograms
Standard Deviation 9.9
|
30.9 Kilograms
Standard Deviation 9.7
|
|
Lower Extremity Muscle Strength- Flexion
Intact Limb: Week 12
|
28.8 Kilograms
Standard Deviation 10.1
|
29.4 Kilograms
Standard Deviation 9.9
|
PRIMARY outcome
Timeframe: 6, 12 wksMobility was measured by the distance walked in 2 minutes.
Outcome measures
| Measure |
Standard Rehabilitation Protocol
n=21 Participants
The usual care is 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. 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
n=23 Participants
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.
|
|---|---|---|
|
Lower Extremity Mobility-Distance
Usual Pace: Week 6
|
5081 inches
Standard Deviation 2324
|
4452 inches
Standard Deviation 1949
|
|
Lower Extremity Mobility-Distance
Usual Pace: Week 12
|
5853 inches
Standard Deviation 2420
|
5657 inches
Standard Deviation 1919
|
|
Lower Extremity Mobility-Distance
Fast Pace: Week 6
|
7308 inches
Standard Deviation 2557
|
6369 inches
Standard Deviation 2316
|
|
Lower Extremity Mobility-Distance
Fast Pace: Week 12
|
8116 inches
Standard Deviation 2763
|
7692 inches
Standard Deviation 2072
|
PRIMARY outcome
Timeframe: 6, 12 wksMobility was measured by the time to complete an "up and go" test.
Outcome measures
| Measure |
Standard Rehabilitation Protocol
n=21 Participants
The usual care is 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. 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
n=23 Participants
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.
|
|---|---|---|
|
Lower Extremity Mobility- Up and Go
Week 6
|
7.3 Seconds
Standard Deviation 3.9
|
7.7 Seconds
Standard Deviation 4.8
|
|
Lower Extremity Mobility- Up and Go
Week 12
|
6.3 Seconds
Standard Deviation 3.5
|
7.1 Seconds
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: 6, 12 wksMobility was measured by the time to complete a timed stair climb.
Outcome measures
| Measure |
Standard Rehabilitation Protocol
n=21 Participants
The usual care is 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. 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
n=23 Participants
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.
|
|---|---|---|
|
Lower Extremity Mobility- Stair Climb
Week 6
|
7.8 Seconds
Standard Deviation 3.8
|
7.5 Seconds
Standard Deviation 4.4
|
|
Lower Extremity Mobility- Stair Climb
Week 12
|
4.7 Seconds
Standard Deviation 3.3
|
5.6 Seconds
Standard Deviation 4.0
|
PRIMARY outcome
Timeframe: 6, 12 wksMobility was measured by the number of stands during the 30-second chair rise test.
Outcome measures
| Measure |
Standard Rehabilitation Protocol
n=21 Participants
The usual care is 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. 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
n=23 Participants
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.
|
|---|---|---|
|
Lower Extremity Mobility-Chair Rise
Week 12
|
21.7 Number of stands
Standard Deviation 9.9
|
19.4 Number of stands
Standard Deviation 9.2
|
|
Lower Extremity Mobility-Chair Rise
Week 6
|
18.1 Number of stands
Standard Deviation 11.4
|
15.7 Number of stands
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 0, 3, 6, 9, 12 wksPain 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.
Outcome measures
| Measure |
Standard Rehabilitation Protocol
n=21 Participants
The usual care is 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. 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
n=23 Participants
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.
|
|---|---|---|
|
Pain Severity
Week 0
|
2.9 units on a scale
Standard Deviation 1.5
|
3.3 units on a scale
Standard Deviation 1.6
|
|
Pain Severity
Week 3
|
2.6 units on a scale
Standard Deviation 1.4
|
2.4 units on a scale
Standard Deviation 1.6
|
|
Pain Severity
Week 6
|
2.2 units on a scale
Standard Deviation 1.7
|
2.2 units on a scale
Standard Deviation 1.4
|
|
Pain Severity
Week 9
|
2.2 units on a scale
Standard Deviation 1.6
|
2.6 units on a scale
Standard Deviation 1.7
|
|
Pain Severity
Week 12
|
1.8 units on a scale
Standard Deviation 1.6
|
2.4 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 0, 3, 6, 9, 12 wksPain 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.
Outcome measures
| Measure |
Standard Rehabilitation Protocol
n=21 Participants
The usual care is 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. 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
n=23 Participants
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.
|
|---|---|---|
|
Pain Interference
Week 0
|
2.9 units on a scale
Standard Deviation 2.4
|
3.1 units on a scale
Standard Deviation 2.4
|
|
Pain Interference
Week 3
|
2.5 units on a scale
Standard Deviation 2.2
|
2.2 units on a scale
Standard Deviation 2.0
|
|
Pain Interference
Week 6
|
2.3 units on a scale
Standard Deviation 2.6
|
2.4 units on a scale
Standard Deviation 2.3
|
|
Pain Interference
Week 9
|
2.0 units on a scale
Standard Deviation 2.5
|
2.8 units on a scale
Standard Deviation 2.7
|
|
Pain Interference
Week 12
|
2.1 units on a scale
Standard Deviation 2.5
|
2.7 units on a scale
Standard Deviation 2.8
|
Adverse Events
Standard Rehabilitation Protocol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NMES w/ Rehab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Laura Talbot
University of Tennessee Health Science Center
Phone: 901-448-3630
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place