| Primary | Lower Extremity Muscle Strength- Extension | Muscle strength was measured with a handheld dynamometer for extensor knee strength of the residual and intact limb. | | Posted | | Mean | Standard Deviation | Kilograms | | 0, 3, 6, 9, 12 wks | | | | ID | Title | Description |
|---|
| OG000 | Standard Rehabilitation Protocol | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| Residual Limb: Week 0 | | | Title | Measurements |
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| - OG00024.5± 10.7
- OG00126.4± 13.4
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| | Residual Limb: Week 3 | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed Models Analysis | | <0.05 | | Slope | 0.90 | Standard Error of the Mean | 0.24 | 2-Sided | | | | | | | | Superiority or Other | | |
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| Primary | 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. | | Posted | | Mean | Standard Deviation | Kilograms | | 0, 3, 6, 9, 12 wks | | | | ID | Title | Description |
|---|
| OG000 | Standard Rehabilitation Protocol | 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. | | OG001 | 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. |
|
| Primary | Lower Extremity Mobility-Distance | Mobility was measured by the distance walked in 2 minutes. | | Posted | | Mean | Standard Deviation | inches | | 6, 12 wks | | | | ID | Title | Description |
|---|
| OG000 | Standard Rehabilitation Protocol | 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. | | OG001 | 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. |
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| Primary | Lower Extremity Mobility- Up and Go | Mobility was measured by the time to complete an "up and go" test. | | Posted | | Mean | Standard Deviation | Seconds | | 6, 12 wks | | | | ID | Title | Description |
|---|
| OG000 | Standard Rehabilitation Protocol | 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. | | OG001 | 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. |
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| Primary | Lower Extremity Mobility- Stair Climb | Mobility was measured by the time to complete a timed stair climb. | | Posted | | Mean | Standard Deviation | Seconds | | 6, 12 wks | | | | ID | Title | Description |
|---|
| OG000 | Standard Rehabilitation Protocol | 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. | | OG001 | 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. |
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| Primary | Lower Extremity Mobility-Chair Rise | Mobility was measured by the number of stands during the 30-second chair rise test. | | Posted | | Mean | Standard Deviation | Number of stands | | 6, 12 wks | | | | ID | Title | Description |
|---|
| OG000 | Standard Rehabilitation Protocol | 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. | | OG001 | 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. |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | units on a scale | | 0, 3, 6, 9, 12 wks | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | units on a scale | | 0, 3, 6, 9, 12 wks | | | | ID | Title | Description |
|---|
| OG000 | Standard Rehabilitation Protocol | 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. | | OG001 | 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. |
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