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Due to limitations caused by COVID, enrollment targets could not be met.
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| Name | Class |
|---|---|
| CyMedica Orthopedics, Inc | INDUSTRY |
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The purpose of this study is to evaluate how different pre-operative therapeutic approaches affect quad strength and patient satisfaction after total knee replacements. There are three treatments groups: standard physical therapy protocol, the use of CyMedica NMES garments, and a telemedical home therapy program.
Patients undergoing total knee replacement (TKR) at Brigham and Women's Faulkner Hospital and meet all eligibility criteria will be informed about the study and asked if they would like to participate. The research assistant (RA) will screen upcoming surgeries and call all qualifying patients to inform them of the study. Those who show interest will be offered the opportunity to discuss with both the RA and Principal Investigator (PI). Upon agreement, the patient's consent will be obtained and they will be randomly assigned to one of three treatment groups using a computer-generated randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1, iGetBetter Group | Experimental | Use only iGetBetter for the 3 months preceding surgery. After surgery, you will be given a new, Post-Op program to use for 2-3 months. For the first 3 weeks, you will only use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks. |
|
| Group 2, E-vive Group | Experimental | You will use iGetBetter starting 3 months out from surgery. You will receive CyMedica's electrical-stimulation garment during the preoperative appointment. In addition to iGetBetter, you will wear the conductive garment two times each day for the last 3 weeks before surgery. After surgery, for the first 3 weeks you will only use the conductive garment, and will not use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to wearing the brace, approximately twice per week for the next 6-8 weeks. You will not need to return the brace after this time is up, and you may keep the brace, if you so choose, at no cost. |
|
| Group 3, Physical Therapy Group | No Intervention | You will receive only iGetBetter for the 3 months preceding surgery. After surgery, you will receive only home physical therapy, and will not use iGetBetter. After those three weeks, you will receive outpatient physical therapy approximately twice per week for the next 6-8 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CyMedica e-vive™ System; CY-1000 | Device | All the patients in Group 2 will be given the CyMedica Orthopedics e-vive system 3 weeks before the surgery. The patients will begin using the unit after their first pre-intervention measurements are taken. Patients will be instructed to apply the e-vive NMES Strength therapy twice a day, 5 days a week. The NMES Strength program is 20 minutes in length. Treatment intensity (adjustable from 1 to 100 in NMES programs) is required to be set at the highest tolerable limit for the patients. Stimulation from the garment will have the following parameters: frequency of 50 Hz; pulse duration of 5 ms; time on: 12.8 seconds; and time off: 10 seconds. The total contraction time in a 20-minute treatment will be 11 minutes. The waveform will be pulsed and asymmetrical. |
| Measure | Description | Time Frame |
|---|---|---|
| Sit-to-stand Time | Change in sit-to-stand capabilities | Preoperative (varies) and postoperative appointments (2 months after surgery) |
| Quadriceps Strength | Change in quadriceps strength in lbs of force, as measured by PT dynamometer | Preoperative and postoperative appointments (2 months after surgery) |
| 2 Minute Walking Time | Change in distance walked in 2 minutes | Preoperative and postoperative appointments (2 months after surgery) |
| Walking Speed | Change in walking speed | Preoperative and postoperative appointments (2 months after surgery) |
| Balancing | Change in proprioception (balance) as measured by 30-second single limb stance PT test | Preoperative and postoperative appointments (2 months after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) Pain | Change in Visual Analog Scale for pain (1-10) 1 no pain 10 worse | first postoperative months (from days post-op through 2-month post-operative appointment) |
| Visual Analogue Scale (VAS) Nausea |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Fitz, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Faulkner Hospital | Boston | Massachusetts | 02130 | United States |
No IPD will be shared with other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1, iGetBetter Group | Use only iGetBetter for the 3 months preceding surgery. After surgery, you will be given a new, Post-Op program to use for 2-3 months. For the first 3 weeks, you will only use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks. iGetBetter telemedicine physical therapy: Group 1 patients will only use a Post-Op program from iGetBetter for the first 3 weeks after surgery. After those 3 weeks have elapsed, Group 1 patients will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks as all other groups. |
| FG001 | Group 2, E-vive Group | You will use iGetBetter starting 3 months out from surgery. You will receive CyMedica's electrical-stimulation garment during the preoperative appointment. In addition to iGetBetter, you will wear the conductive garment two times each day for the last 3 weeks before surgery. After surgery, for the first 3 weeks you will only use the conductive garment, and will not use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to wearing the brace, approximately twice per week for the next 6-8 weeks. You will not need to return the brace after this time is up, and you may keep the brace, if you so choose, at no cost. CyMedica e-vive™ System; CY-1000: All the patients in Group 2 will be given the CyMedica Orthopedics e-vive system 3 weeks before the surgery. The patients will begin using the unit after their first pre-intervention measurements are taken. Patients will be instructed to apply the e-vive NMES Strength therapy twice a day, 5 days a week. The NMES Strength program is 20 minutes in length. Treatment intensity (adjustable from 1 to 100 in NMES programs) is required to be set at the highest tolerable limit for the patients. Stimulation from the garment will have the following parameters: frequency of 50 Hz; pulse duration of 5 ms; time on: 12.8 seconds; and time off: 10 seconds. The total contraction time in a 20-minute treatment will be 11 minutes. The waveform will be pulsed and asymmetrical. |
| FG002 | Group 3, Physical Therapy Group | You will receive only iGetBetter for the 3 months preceding surgery. After surgery, you will receive only home physical therapy, and will not use iGetBetter. After those three weeks, you will receive outpatient physical therapy approximately twice per week for the next 6-8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1, iGetBetter Group | Use only iGetBetter for the 3 months preceding surgery. After surgery, you will be given a new, Post-Op program to use for 2-3 months. For the first 3 weeks, you will only use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks. iGetBetter telemedicine physical therapy: Group 1 patients will only use a Post-Op program from iGetBetter for the first 3 weeks after surgery. After those 3 weeks have elapsed, Group 1 patients will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks as all other groups. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sit-to-stand Time | Change in sit-to-stand capabilities | Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported. | Posted | Preoperative (varies) and postoperative appointments (2 months after surgery) |
|
148 days (21.14 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1, iGetBetter Group | Use only iGetBetter for the 3 months preceding surgery. After surgery, you will be given a new, Post-Op program to use for 2-3 months. For the first 3 weeks, you will only use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks. iGetBetter telemedicine physical therapy: Group 1 patients will only use a Post-Op program from iGetBetter for the first 3 weeks after surgery. After those 3 weeks have elapsed, Group 1 patients will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks as all other groups. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Advanced Home PT Required | General disorders | Systematic Assessment | Subject was determined to require more advanced home physical therapy. |
Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wolfgang Fitz | Brigham Health | 617-732-9501 | wfitz@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2019 | May 28, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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Participants assigned to one of three groups, there is no crossover. Participants remain in their assigned group until completion of study.
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| iGetBetter telemedicine physical therapy | Other | Group 1 patients will only use a Post-Op program from iGetBetter for the first 3 weeks after surgery. After those 3 weeks have elapsed, Group 1 patients will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks as all other groups. |
|
Change in VAS nausea (Visual Analog Scale for nausea (1-10) 1 no nausea 10 worse nausea )
| first postoperative months (from days post-op through 2-month post-operative appointment) |
| Visual Analogue Scale (VAS) Satisfaction | Change in VAS satisfaction (Visual Analog Scale for satisfaction (1-10) 1 not satisfied, 10 totally unsatisfied) | first postoperative months (from days post-op through 2-month post-operative appointment) |
| Readmission Rate | major complication | Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery) |
| Infection Rate | superficial and deep infection | Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery) |
| Cost Per Treatment Regimen (iGetBetter vs. CyMedica E-vive vs. Home PT) | We will calculate the total cost of each treatment modality | Completion of study (anticipate one year from start data 4/4/2019) |
| BG001 | Group 2, E-vive Group | You will use iGetBetter starting 3 months out from surgery. You will receive CyMedica's electrical-stimulation garment during the preoperative appointment. In addition to iGetBetter, you will wear the conductive garment two times each day for the last 3 weeks before surgery. After surgery, for the first 3 weeks you will only use the conductive garment, and will not use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to wearing the brace, approximately twice per week for the next 6-8 weeks. You will not need to return the brace after this time is up, and you may keep the brace, if you so choose, at no cost. CyMedica e-vive™ System; CY-1000: All the patients in Group 2 will be given the CyMedica Orthopedics e-vive system 3 weeks before the surgery. The patients will begin using the unit after their first pre-intervention measurements are taken. Patients will be instructed to apply the e-vive NMES Strength therapy twice a day, 5 days a week. The NMES Strength program is 20 minutes in length. Treatment intensity (adjustable from 1 to 100 in NMES programs) is required to be set at the highest tolerable limit for the patients. Stimulation from the garment will have the following parameters: frequency of 50 Hz; pulse duration of 5 ms; time on: 12.8 seconds; and time off: 10 seconds. The total contraction time in a 20-minute treatment will be 11 minutes. The waveform will be pulsed and asymmetrical. |
| BG002 | Group 3, Physical Therapy Group | You will receive only iGetBetter for the 3 months preceding surgery. After surgery, you will receive only home physical therapy, and will not use iGetBetter. After those three weeks, you will receive outpatient physical therapy approximately twice per week for the next 6-8 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
| Sex: Female, Male |
|
| Race (NIH/OMB) |
|
| OG001 | Group 2, E-vive Group | You will use iGetBetter starting 3 months out from surgery. You will receive CyMedica's electrical-stimulation garment during the preoperative appointment. In addition to iGetBetter, you will wear the conductive garment two times each day for the last 3 weeks before surgery. After surgery, for the first 3 weeks you will only use the conductive garment, and will not use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to wearing the brace, approximately twice per week for the next 6-8 weeks. You will not need to return the brace after this time is up, and you may keep the brace, if you so choose, at no cost. CyMedica e-vive™ System; CY-1000: All the patients in Group 2 will be given the CyMedica Orthopedics e-vive system 3 weeks before the surgery. The patients will begin using the unit after their first pre-intervention measurements are taken. Patients will be instructed to apply the e-vive NMES Strength therapy twice a day, 5 days a week. The NMES Strength program is 20 minutes in length. Treatment intensity (adjustable from 1 to 100 in NMES programs) is required to be set at the highest tolerable limit for the patients. Stimulation from the garment will have the following parameters: frequency of 50 Hz; pulse duration of 5 ms; time on: 12.8 seconds; and time off: 10 seconds. The total contraction time in a 20-minute treatment will be 11 minutes. The waveform will be pulsed and asymmetrical. |
| OG002 | Group 3, Physical Therapy Group | You will receive only iGetBetter for the 3 months preceding surgery. After surgery, you will receive only home physical therapy, and will not use iGetBetter. After those three weeks, you will receive outpatient physical therapy approximately twice per week for the next 6-8 weeks. |
|
| Primary | Quadriceps Strength | Change in quadriceps strength in lbs of force, as measured by PT dynamometer | Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported. | Posted | Preoperative and postoperative appointments (2 months after surgery) |
|
|
| Primary | 2 Minute Walking Time | Change in distance walked in 2 minutes | Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported. | Posted | Preoperative and postoperative appointments (2 months after surgery) |
|
|
| Primary | Walking Speed | Change in walking speed | Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported. | Posted | Preoperative and postoperative appointments (2 months after surgery) |
|
|
| Primary | Balancing | Change in proprioception (balance) as measured by 30-second single limb stance PT test | Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported. | Posted | Preoperative and postoperative appointments (2 months after surgery) |
|
|
| Secondary | Visual Analogue Scale (VAS) Pain | Change in Visual Analog Scale for pain (1-10) 1 no pain 10 worse | Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported. | Posted | first postoperative months (from days post-op through 2-month post-operative appointment) |
|
|
| Secondary | Visual Analogue Scale (VAS) Nausea | Change in VAS nausea (Visual Analog Scale for nausea (1-10) 1 no nausea 10 worse nausea ) | Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported. | Posted | first postoperative months (from days post-op through 2-month post-operative appointment) |
|
|
| Secondary | Visual Analogue Scale (VAS) Satisfaction | Change in VAS satisfaction (Visual Analog Scale for satisfaction (1-10) 1 not satisfied, 10 totally unsatisfied) | Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported. | Posted | first postoperative months (from days post-op through 2-month post-operative appointment) |
|
|
| Secondary | Readmission Rate | major complication | Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported. | Posted | Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery) |
|
|
| Secondary | Infection Rate | superficial and deep infection | Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported. | Posted | Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery) |
|
|
| Secondary | Cost Per Treatment Regimen (iGetBetter vs. CyMedica E-vive vs. Home PT) | We will calculate the total cost of each treatment modality | Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported. | Posted | Completion of study (anticipate one year from start data 4/4/2019) |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | Group 2, E-vive Group | You will use iGetBetter starting 3 months out from surgery. You will receive CyMedica's electrical-stimulation garment during the preoperative appointment. In addition to iGetBetter, you will wear the conductive garment two times each day for the last 3 weeks before surgery. After surgery, for the first 3 weeks you will only use the conductive garment, and will not use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to wearing the brace, approximately twice per week for the next 6-8 weeks. You will not need to return the brace after this time is up, and you may keep the brace, if you so choose, at no cost. CyMedica e-vive™ System; CY-1000: All the patients in Group 2 will be given the CyMedica Orthopedics e-vive system 3 weeks before the surgery. The patients will begin using the unit after their first pre-intervention measurements are taken. Patients will be instructed to apply the e-vive NMES Strength therapy twice a day, 5 days a week. The NMES Strength program is 20 minutes in length. Treatment intensity (adjustable from 1 to 100 in NMES programs) is required to be set at the highest tolerable limit for the patients. Stimulation from the garment will have the following parameters: frequency of 50 Hz; pulse duration of 5 ms; time on: 12.8 seconds; and time off: 10 seconds. The total contraction time in a 20-minute treatment will be 11 minutes. The waveform will be pulsed and asymmetrical. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | Group 3, Physical Therapy Group | You will receive only iGetBetter for the 3 months preceding surgery. After surgery, you will receive only home physical therapy, and will not use iGetBetter. After those three weeks, you will receive outpatient physical therapy approximately twice per week for the next 6-8 weeks. | 0 | 7 | 0 | 7 | 0 | 7 |
|
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| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |