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Prospective evaluation of patient compliance and prescribed home exercise program using MotionSense wearable system during recovery from primary total knee arthroplasty.
During the proposed study, the MotionSense wearable system will be used by patients undergoing total knee arthroplasty (TKA) surgery leading up to and after their surgery. The patients will be using the system to monitor their recovery during daily activities, log daily pain scores and patient reported outcomes while also supporting their prescribed home exercise program. Each patient will thereby participate in outpatient physiotherapy in line with their current standard of care, while the physiotherapist will leverage the opportunities of the presented platform to give the patient personalized reminders for their patient-specific home exercise program. The surgeon / research nurse will additionally be able to monitor the patients recovery remotely as the sensor / app data is shared to the OrthoLogIQ platform.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MotionSense Wearable | Other | Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MotionSense | Device | MotionSense Wearable: Remote patient monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Hours of MotionSense Use Per Day in Office | Hours spent per day in office by practice using MotionSense wearable system, from 30 days preoperative to 90 days postoperative. | 30 days preoperative to 90 days postoperative |
| Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Number of Days Use After / Prior to Surgery | Initial and last day worn while wearing MotionSense from 30 days preoperative to 90 days postoperative | 30 days preoperative to 90 days postoperative |
| Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires | Count of participants who have completed the aggregate questionnaires in the MotionSense App downloaded to their mobile devices at each timepoint for evaluation of compliance with the MotionSense Wearable System. | Preoperative, 2 weeks postoperative, 6 weeks postoperative, 90 days postoperative |
| Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Home Exercise Program | Percent of exercise sessions completed while wearing MotionSense from 30 days preoperative to 90 days postoperative. An exercise session is a collection of exercises that can be customized and assigned to a patient to be performed either once or twice a day. | 30 days preoperative to 90 days postoperative |
| Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Patient Onboarding Time in Surgeon Clinic | Minutes spent per patient at preoperative onboarding visit. Onboarding visit provided patients with instructions on system use and initial wearable installation. | Preoperative onboarding visit |
| Measure | Description | Time Frame |
|---|---|---|
| Correlate Functional and Patient Reported Outcome Metrics | Spearman correlation of mean step count to Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire. The Statistical Spearman correlation coefficient evaluates relationships between variables. The Spearman correlation coefficient is used to evaluate the relationship of the mean step count to the Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire. The KOOS consists of 5 subscales: Pain, other symptoms, function in daily living (ADL), function in sport and recreation and knee related quality of life (QOL). The Spearman Correlation coefficients range from -1to 1. If r = 0, there is no linear relationship between the variables. If r=+1, there is a strong direct relationship. If r = -1, there is a strong inverse relationship. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma Joint Reconstruction Institute | Oklahoma City | Oklahoma | 73114 | United States | ||
| Robotic Joint Replacement Institute LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | Motionsense Wearable Group | Using Motionsense from pre-op to 90 days post-op during the recovery after primary TKA Motionsense Wearable: Remote patient monitoring |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Motionsense Wearable Group | Using Motionsense from up to 30 days pre-op and 90 days post-op during the recovery after primary TKA Motionsense Wearable: Remote patient monitoring |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Hours of MotionSense Use Per Day in Office | Hours spent per day in office by practice using MotionSense wearable system, from 30 days preoperative to 90 days postoperative. | The office staff did not collect data on the hours spent per day in office, except for onboarding time, which is Outcome Measure 5. | Posted | 30 days preoperative to 90 days postoperative |
|
|
30 days pre-op until 90 days post-op
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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 | Motionsense Wearable Group | Using Motionsense from up to 30 days pre-op and 90 days post-op during the recovery after primary TKA Motionsense Wearable: Remote patient monitoring |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep joint infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment | Bacterial infection was the result of a plastic surgery. Source was plastic surgery, not the total knee SURGERY. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
Comment for Document Section: Initially the Ethical Review Committee did not request a detailed Statistical Analysis Plan. The Statistical Analysis Plan was uploaded to describe the standard analysis for descriptive statics. The study concluded on August 1, 2022. Therefore, belated IRB approval of the standard statistical analysis plan was not requested.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Barga | Stryker | +12018315073 | Kevin.Barga@stryker.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 15, 2021 | May 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 18, 2023 | May 18, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | Daily percentage of patients prescribed each home exercise during preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative time periods. Isometric quads: Lie back to floor, tense quadriceps, hold, repeat. Sit-to-stands: Sit, stand, strengthen, repeat. Short-arc quadriceps: Lie back to floor with leg bent, extend leg, hold, repeat. Heel slides: Lie back to floor, slide and bend leg, hold, repeat. Hamstring curls: Lie stomach to floor, bend leg, hold, repeat. Long-arc quadriceps: Sit, lift, hold, count, repeat, strengthen. Straight leg raises: Lie back to floor, lift leg, hold, lower, repeat. Standing knee bends: Stand, squat, knees, lower, maintain form, repeat. Knee straightening stretches: Lie back to floor, extend leg, tense, relax. Sitting knee bends: Sit, hold, stretch, hold, slide, repeat. Assisted knee stretches: Sit, bend, hold, release, repeat. Warmup: 5 minutes | Preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative |
| 2 weeks, 6 weeks, 90 days postoperative |
| Evaluate Convenience of Using the MotionSense System: Number of Leg Registrations Performed (Per Day) | Number of leg registrations performed (per day) per patient, while wearing MotionSense from 30 days preoperative to 90 days postoperative. | 30 days preoperative to 90 days postoperative |
| Evaluate Convenience of Using the MotionSense System: Number of (Weekly / Daily) Patches Used | Number of weekly and daily patches used per patient, while wearing MotionSense from 30 days preoperative to 90 days postoperative. | 30 days preoperative to 90 days postoperative |
| Evaluate Convenience of Using the MotionSense System: Number of Wound Pictures Shared With Surgeon Office | Total number of wound pictures shared with surgeon office per patient while wearing MotionSense from 30 days preoperative to 90 days postoperative | 30 days preoperative to 90 days postoperative |
| Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily VAS Pain Scores | Visual Analog Scale (VAS) pain scores while wearing MotionSense from 30 days preoperative to 90 days postoperative The VAS pain score is a patient questionnaire to assess the subjective pain intensity. The VAS is a horizontal line ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. | 30 days preoperative to 90 days postoperative |
| Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily Steps | Daily steps while wearing MotionSense from 30 days preoperative to 90 days postoperative | 30 days preoperative to 90 days postoperative |
| Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Knee Active and Weight Bearing Time | Scores while wearing MotionSense from 30 days preoperative to 90 days postoperative Knee active time is the time the patient spends moving the knee per day. Weight bearing time is the time the patient spends with the leg in an upright position per day. | 30 days preoperative to 90 days postoperative |
| Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Range of Motion | Scores while wearing MotionSense from 30 days preoperative to 90 days postoperative Range of Motion (ROM) for the knee refers to the degree of movement that can be achieved at the knee joint. It describes the arc or extent of motion from full extension (straightening) to full flexion (bending) in degrees. | 30 days preoperative to 90 days postoperative |
| Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Gait Quality (Steps Per Minute) | Steps per minute while wearing MotionSense from 30 days preoperative to 90 days postoperative | 30 days preoperative to 90 days postoperative |
| Wakefield |
| Rhode Island |
| 02879 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
| Primary | Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Number of Days Use After / Prior to Surgery | Initial and last day worn while wearing MotionSense from 30 days preoperative to 90 days postoperative | Preoperative participants: 2 Patients did not wear device preoperatively. Postoperative participants: 23 Patients did not wear device postoperatively. | Posted | Median | Inter-Quartile Range | Days relative to surgery | 30 days preoperative to 90 days postoperative |
|
|
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| Primary | Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires | Count of participants who have completed the aggregate questionnaires in the MotionSense App downloaded to their mobile devices at each timepoint for evaluation of compliance with the MotionSense Wearable System. | Posted | Count of Participants | Participants | Preoperative, 2 weeks postoperative, 6 weeks postoperative, 90 days postoperative |
|
|
|
| Primary | Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Home Exercise Program | Percent of exercise sessions completed while wearing MotionSense from 30 days preoperative to 90 days postoperative. An exercise session is a collection of exercises that can be customized and assigned to a patient to be performed either once or twice a day. | There were 10 patients who did not have any exercise data that was completed. | Posted | Median | Inter-Quartile Range | Percent of completed exercise sessions | 30 days preoperative to 90 days postoperative |
|
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| Primary | Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Patient Onboarding Time in Surgeon Clinic | Minutes spent per patient at preoperative onboarding visit. Onboarding visit provided patients with instructions on system use and initial wearable installation. | There were 7 patients who did not have onboarding time data collected. | Posted | Median | Inter-Quartile Range | Minutes | Preoperative onboarding visit |
|
|
|
| Primary | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | Daily percentage of patients prescribed each home exercise during preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative time periods. Isometric quads: Lie back to floor, tense quadriceps, hold, repeat. Sit-to-stands: Sit, stand, strengthen, repeat. Short-arc quadriceps: Lie back to floor with leg bent, extend leg, hold, repeat. Heel slides: Lie back to floor, slide and bend leg, hold, repeat. Hamstring curls: Lie stomach to floor, bend leg, hold, repeat. Long-arc quadriceps: Sit, lift, hold, count, repeat, strengthen. Straight leg raises: Lie back to floor, lift leg, hold, lower, repeat. Standing knee bends: Stand, squat, knees, lower, maintain form, repeat. Knee straightening stretches: Lie back to floor, extend leg, tense, relax. Sitting knee bends: Sit, hold, stretch, hold, slide, repeat. Assisted knee stretches: Sit, bend, hold, release, repeat. Warmup: 5 minutes | Posted | Median | Inter-Quartile Range | Percent of participants assigned | Preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative |
|
|
|
| Secondary | Correlate Functional and Patient Reported Outcome Metrics | Spearman correlation of mean step count to Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire. The Statistical Spearman correlation coefficient evaluates relationships between variables. The Spearman correlation coefficient is used to evaluate the relationship of the mean step count to the Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire. The KOOS consists of 5 subscales: Pain, other symptoms, function in daily living (ADL), function in sport and recreation and knee related quality of life (QOL). The Spearman Correlation coefficients range from -1to 1. If r = 0, there is no linear relationship between the variables. If r=+1, there is a strong direct relationship. If r = -1, there is a strong inverse relationship. | At 2 weeks (-5 days), 60 patients did not have completed data for KOOS or step count. At 6 weeks (-5 days), 61 patients did not have completed data for KOOS or step count. At 90 days (-5 days), 90 patients did not have completed data for KOOS or step count. | Posted | Number | Spearman Correlation Coefficient | 2 weeks, 6 weeks, 90 days postoperative |
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| Secondary | Evaluate Convenience of Using the MotionSense System: Number of Leg Registrations Performed (Per Day) | Number of leg registrations performed (per day) per patient, while wearing MotionSense from 30 days preoperative to 90 days postoperative. | The number of leg registrations performed per day per patient was not collected. These data collections were not technically feasible. | Posted | 30 days preoperative to 90 days postoperative |
|
|
| Secondary | Evaluate Convenience of Using the MotionSense System: Number of (Weekly / Daily) Patches Used | Number of weekly and daily patches used per patient, while wearing MotionSense from 30 days preoperative to 90 days postoperative. | The number of weekly and daily patches used per patient was not collected. Accurate data collection was unattainable by office staff. | Posted | 30 days preoperative to 90 days postoperative |
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| Secondary | Evaluate Convenience of Using the MotionSense System: Number of Wound Pictures Shared With Surgeon Office | Total number of wound pictures shared with surgeon office per patient while wearing MotionSense from 30 days preoperative to 90 days postoperative | Posted | Mean | Inter-Quartile Range | Shared pictures | 30 days preoperative to 90 days postoperative |
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| Secondary | Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily VAS Pain Scores | Visual Analog Scale (VAS) pain scores while wearing MotionSense from 30 days preoperative to 90 days postoperative The VAS pain score is a patient questionnaire to assess the subjective pain intensity. The VAS is a horizontal line ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. | 4 patients were not included in the analysis because they did not produce pain scores. | Posted | Median | Inter-Quartile Range | units on a scale | 30 days preoperative to 90 days postoperative |
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| Secondary | Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily Steps | Daily steps while wearing MotionSense from 30 days preoperative to 90 days postoperative | There were 4 patients who did not produce daily steps or wear device for longer than 10 minutes per day. | Posted | Median | Inter-Quartile Range | Daily steps | 30 days preoperative to 90 days postoperative |
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| Secondary | Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Knee Active and Weight Bearing Time | Scores while wearing MotionSense from 30 days preoperative to 90 days postoperative Knee active time is the time the patient spends moving the knee per day. Weight bearing time is the time the patient spends with the leg in an upright position per day. | There were 4 patients who did not produce knee active or weight bearing time, or wear the device for greater than 10 minutes per day. | Posted | Median | Inter-Quartile Range | minutes | 30 days preoperative to 90 days postoperative |
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| Secondary | Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Range of Motion | Scores while wearing MotionSense from 30 days preoperative to 90 days postoperative Range of Motion (ROM) for the knee refers to the degree of movement that can be achieved at the knee joint. It describes the arc or extent of motion from full extension (straightening) to full flexion (bending) in degrees. | There were 12 patients who did not produce ROM data, wear the device for long enough (>10 mins/day), or were excluded due to data quality concerns. | Posted | Median | Inter-Quartile Range | Degrees | 30 days preoperative to 90 days postoperative |
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| Secondary | Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Gait Quality (Steps Per Minute) | Steps per minute while wearing MotionSense from 30 days preoperative to 90 days postoperative | Gait analysis was incomplete for 16 patients. | Posted | Median | Inter-Quartile Range | Steps per minute | 30 days preoperative to 90 days postoperative |
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|
| 0 |
| 101 |
| 2 |
| 101 |
| 10 |
| 101 |
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| Knee stiffness Arthrofibrosis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment | Pain and stiffness requiring manipulation under anesthesia |
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| Postoperative day of initial use |
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| Postoperative day of last use |
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| Title | Measurements |
|---|---|
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| Postoperative 90 day questionnaire |
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| Title | Measurements |
|---|---|
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| Pre-op: Heel slides |
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| Pre-op: Hamstring curls |
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| Pre-op: Long-arc quads |
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| Pre-op: Straight-leg raises |
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| Pre-op: Standing knee bends |
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| Pre-op: Knee straightening stretches |
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| Pre-op: Sitting knee bends |
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| Pre-op: Assisted knee stretches |
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| Pre-op: Warmup |
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| 0-30 days post-op: Isometric quads |
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| 0-30 days post-op: Sit-to-stands |
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| 0-30 days post-op: Short-arc quads |
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| 0-30 days post-op: Heel slides |
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| 0-30 days post-op: Hamstring curls |
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| 0-30 days post-op: Long-arc quads |
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| 0-30 days post-op: Straight-leg raises |
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| 0-30 days post-op: Standing knee bends |
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| 0-30 days post-op: Knee straightening |
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| 0-30 days post-op: Sitting knee bends |
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| 0-30 days post-op: Assisted knee stretches |
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| 0-30 days post-op: Warm |
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| 31-60 days post-op: Isometric quads |
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| 31-60 days post-op: Sit-to-stands |
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| 31-60 days post-op: Short-arc quads |
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| 31-60 days post-op: Heel slides |
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| 31-60 days post-op: Hamstring curls |
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| 31-60 days post-op: Long-arc quads |
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| 31-60 days post-op: Straight-leg raises |
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| 31-60 days post-op: Standing knee bends |
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| 31-60 days post-op: Knee straightening |
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| 31-60 days post-op: Sitting knee bends |
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| 31-60 days post-op: Assisted knee stretches |
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| 31-60 days post-op: Warmup |
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| 61-90 days post-op: Isometric quads |
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| 61-90 days post-op: Sit-to-stands |
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| 61-90 days post-op: Short-arc quads |
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| 61-90 days post-op: Heel slides |
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| 61-90 days post-op: Hamstring curls |
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| 61-90 days post-op: Long-arc quads |
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| 61-90 days post-op: Straight-leg raises |
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| 61-90 days post-op: Standing knee bends |
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| 61-90 days post-op: Knee straightening |
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| 61-90 days post-op: Sitting knee bends |
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| Assisted knee stretches |
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| 61-90 days post-op: Warmup |
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| KOOS: ADL, 90 days |
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| KOOS: Pain, 2 weeks |
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| KOOS: Pain, 6 weeks |
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| KOOS: Pain, 90 days |
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| KOOS: QoL, 2 weeks |
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| KOOS: QoL, 6 weeks |
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| KOOS: QoL, 90 days |
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| KOOS: Sport/Recreation, 2 weeks |
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| KOOS: Sport/Recreation, 6 weeks |
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| KOOS: Sport/Recreation, 90 days |
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| KOOS: Symptoms, 2 weeks |
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| KOOS: Symptoms, 6 weeks |
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| KOOS: Symptoms, 90 days |
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