FS5 Limited Market Release - MotionSense Clinical Use Evaluation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Orthosensor, Inc.
- Enrollment
- 101
- Locations
- 2
- Primary Endpoint
- Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Number of Days Use After / Prior to Surgery
Study Overview
Brief Summary
Prospective evaluation of patient compliance and prescribed home exercise program using MotionSense wearable system during recovery from primary total knee arthroplasty.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Planned for unilateral total knee surgery in the coming 4 weeks
- •Age 50 to 80
- •Owns a smart phone
Exclusion Criteria
- •BMI exceeding 35
- •Severe skin conditions
Arms & Interventions
MotionSense Wearable
Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA
Intervention: MotionSense (Device)
Outcomes
Primary Outcomes
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Number of Days Use After / Prior to Surgery
Time Frame: 30 days preoperative to 90 days postoperative
Initial and last day worn while wearing MotionSense from 30 days preoperative to 90 days postoperative
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Home Exercise Program
Time Frame: 30 days preoperative to 90 days postoperative
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.
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Hours of MotionSense Use Per Day in Office
Time Frame: 30 days preoperative to 90 days postoperative
Hours spent per day in office by practice using MotionSense wearable system, from 30 days preoperative to 90 days postoperative.
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires
Time Frame: Preoperative, 2 weeks postoperative, 6 weeks postoperative, 90 days postoperative
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.
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Patient Onboarding Time in Surgeon Clinic
Time Frame: Preoperative onboarding visit
Minutes spent per patient at preoperative onboarding visit. Onboarding visit provided patients with instructions on system use and initial wearable installation.
Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists
Time Frame: Preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative
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
Secondary Outcomes
- Evaluate Convenience of Using the MotionSense System: Number of Leg Registrations Performed (Per Day)(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(30 days preoperative to 90 days postoperative)
- Evaluate Convenience of Using the MotionSense System: Number of (Weekly / Daily) Patches Used(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(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)(30 days preoperative to 90 days postoperative)
- Correlate Functional and Patient Reported Outcome Metrics(2 weeks, 6 weeks, 90 days postoperative)
- Evaluate Convenience of Using the MotionSense System: Number of Wound Pictures Shared With Surgeon Office(30 days preoperative to 90 days postoperative)
- Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily Steps(30 days preoperative to 90 days postoperative)
- Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Range of Motion(30 days preoperative to 90 days postoperative)