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Completed

NCT Number: NCT05091918

Limited Market Release - MotionSense Clinical Use Evaluation

Prospective evaluation of patient compliance and prescribed home exercise program using MotionSense wearable system during recovery from primary total knee arthroplasty.

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Key information

Conditions

Knee Arthroplasty Behavior Health Behavior Patient Acceptance of Health Care Patient Engagement Patient Participation Patient-Reported Outcome Measures (PROMs) Treatment Adherence and Compliance

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma Joint Reconstruction Institute, Oklahoma City, Oklahoma, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MotionSense

Device

MotionSense Wearable: Remote patient monitoring

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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

  1. Correlate Functional and Patient Reported Outcome Metrics

    Time frame: 2 weeks, 6 weeks, 90 days postoperative

    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.

  2. Evaluate Convenience of Using the MotionSense System: Number of Leg Registrations Performed (Per Day)

    Time frame: 30 days preoperative to 90 days postoperative

    Number of leg registrations performed (per day) per patient, while wearing MotionSense from 30 days preoperative to 90 days postoperative.

  3. Evaluate Convenience of Using the MotionSense System: Number of (Weekly / Daily) Patches Used

    Time frame: 30 days preoperative to 90 days postoperative

    Number of weekly and daily patches used per patient, while wearing MotionSense from 30 days preoperative to 90 days postoperative.

  4. Evaluate Convenience of Using the MotionSense System: Number of Wound Pictures Shared With Surgeon Office

    Time frame: 30 days preoperative to 90 days postoperative

    Total number of wound pictures shared with surgeon office per patient while wearing MotionSense from 30 days preoperative to 90 days postoperative

  5. Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily VAS Pain Scores

    Time frame: 30 days preoperative to 90 days postoperative

    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.

  6. Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily Steps

    Time frame: 30 days preoperative to 90 days postoperative

    Daily steps while wearing MotionSense from 30 days preoperative to 90 days postoperative

  7. Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Knee Active and Weight Bearing Time

    Time frame: 30 days preoperative to 90 days postoperative

    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.

  8. Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Range of Motion

    Time frame: 30 days preoperative to 90 days postoperative

    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.

  9. Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Gait Quality (Steps Per Minute)

    Time frame: 30 days preoperative to 90 days postoperative

    Steps per minute while wearing MotionSense from 30 days preoperative to 90 days postoperative

Sponsors and collaborators

Lead sponsor

Orthosensor, Inc.

Industry

Registry information

Official study title

FS5 Limited Market Release - MotionSense Clinical Use Evaluation

Acronym: FS5

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2021
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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