Wearable Sensor Monitoring for Post-Surgical Sports Rehabilitation

Recruiting at 1 trial location

Overseen By James Voos, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Non-English speakers, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

226 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will utilize the Moxy wearable sensor to measure muscle oxygen saturation levels in athletes following lower extremity surgery (ACL or Hip arthroscopy) to evaluate their Return-to-Play. The acquired data will complement current protocols utilized by Dr. Voos and Dr. Salata in this regard and will add quantifiable evidence to enable a robust measurement of the surgical limb versus non-surgical limb.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is the Moxy Muscle Oxygen Sensor safe for use in humans?

The Moxy Muscle Oxygen Sensor, which uses near-infrared light to measure muscle oxygen levels, has been studied for its reliability and validity during exercise. While the studies focus on its accuracy and reliability, they do not report any safety concerns, suggesting it is generally safe for use in humans. ^{1 2 3 4 5}

How does the wearable sensor monitoring treatment differ from other treatments for post-surgical sports rehabilitation?

This treatment is unique because it uses wearable sensors to monitor vital signs and body movements directly from the body in a non-invasive way, allowing for real-time, remote tracking of rehabilitation progress without the need for constant clinical supervision. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment Monitored Work-out, Moxy, Moxy Monitor, Moxy Muscle Oxygen Sensor, Moxy Oxygen Sensor Device, Moxy Oxygen Sensor Device, Moxy Muscle Oxygen Monitor, Moxy O2 Sensor, Physical Therapy, Physical Therapy, Prehabilitation Exercise Regimen, Rehabilitation Therapy for post-surgical sports rehabilitation?

Wearable sensors, like those used in the Moxy devices, have been shown to effectively monitor physiological parameters and body movements, which can enhance sports performance and rehabilitation after surgery by providing accurate, non-invasive feedback on a user's health status. This technology allows for objective tracking of rehabilitation progress, potentially improving outcomes by enabling personalized and precise adjustments to therapy. ^{5 10 11 12 13}

Research Team

James Voos, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Sunita Mengers, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

This trial is for healthy individuals aged 14 to 22 who are recovering from ACL or hip arthroscopic surgery. It's not suitable for those under 14, over 22, non-English speakers, or pregnant individuals.

Inclusion Criteria

I am between 14 and 30 years old.

I have never had ACL, knee, or hip surgery.

I need surgery for my ACL injury.

Exclusion Criteria

Pregnant individuals

I am either younger than 14 or older than 30.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Patients undergo arthroscopic ACL or hip surgery and begin initial recovery

6 weeks

1 visit (in-person)

Rehabilitation and Monitoring

Patients participate in physical therapy and are monitored using the Moxy sensor at set time points

9 months

4 visits (in-person) at 6-week, 12-week, 6 months, and 9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Monitored Work-out
• Moxy Oxygen Sensor Device
• Physical Therapy

Trial Overview The study tests how well a Moxy wearable sensor can track muscle oxygen levels during rehabilitation from lower extremity surgeries. The goal is to improve return-to-play protocols by comparing the operated limb with the non-operated one.

Participant Groups

Group I: Surgical Patients Experimental Treatment 2 Interventions

Patients who have undergone arthroscopic ACL surgery or arthroscopic hip surgery and are undergoing physical therapy for return to sport

Group II: Healthy Individuals Experimental Treatment 2 Interventions

Healthy control patients with no history of knee or hip surgery for comparison of baseline values

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Findings from Research

A systematic review of five studies on wearable activity monitors and smartphone apps for rehabilitation after total hip replacement (THR) found limited evidence supporting their long-term efficacy in enhancing recovery and patient monitoring.

The review highlights the need for further research to identify which specific technologies are most beneficial for patients and how they can effectively improve clinical outcomes after THR surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of current use of commercial wearable technology and smartphone apps with application in monitoring individuals following total hip replacement surgery. Bahadori, S., Collard, S., Williams, JM., et al.[2021]

Wearable sensors can accurately and non-invasively monitor vital signs and physiological parameters, making them a promising alternative to expensive clinical detection systems that require medical staff for operation.

These technologies enable athletes to objectively track their performance and body movements, enhancing rehabilitation monitoring and training effectiveness beyond traditional subjective evaluations by coaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Sensors and Smart Devices to Monitor Rehabilitation Parameters and Sports Performance: An Overview. De Fazio, R., Mastronardi, VM., De Vittorio, M., et al.[2023]

Wearable performance devices, such as GPS and accelerometers, allow athletes and healthcare professionals to monitor real-time physiological and movement parameters, which can help optimize training and reduce injury risk.

Despite their potential, the current evidence supporting the effectiveness of these devices in professional sports is limited, indicating a need for further research to develop standardized training protocols based on the data collected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Performance Devices in Sports Medicine. Li, RT., Kling, SR., Salata, MJ., et al.[2018]

Wearable sensors are revolutionizing rehabilitation by allowing for the tracking and quantification of movement in patients with neurological and musculoskeletal conditions, which can lead to better personalized care.

These sensors not only help in identifying motor recovery mechanisms but also facilitate remote monitoring and telerehabilitation, making them valuable tools for conditions like stroke and knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Movement Sensors for Rehabilitation: A Focused Review of Technological and Clinical Advances. Porciuncula, F., Roto, AV., Kumar, D., et al.[2023]

A qualitative study involving 17 physical therapists and 3 individuals with stroke identified key considerations for developing stroke-specific wearable monitoring technology, emphasizing the need for devices that accommodate the variability in patient needs and rehabilitation goals.

Stakeholders believe that such technology could significantly enhance rehabilitation practices, but it must include crucial design features and address barriers to adoption to be effectively integrated into clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on the prospective development of stroke-specific lower extremity wearable monitoring technology: a qualitative focus group study with physical therapists and individuals with stroke. Louie, DR., Bird, ML., Menon, C., et al.[2020]

The Moxy muscle oxygen monitor reliably measures local oxygen saturation (SmO2) at low to moderate exercise intensities, showing strong correlations between trials and with whole-body oxygen consumption (VO2).

However, its reliability decreases at higher intensities, likely due to increased movement artifacts, and total hemoglobin (THb) measurements do not effectively indicate muscle oxygenation during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity and reliability of the Moxy oxygen monitor during incremental cycling exercise. Crum, EM., O'Connor, WJ., Van Loo, L., et al.[2019]

A new wearable integrated system combining muscle oximetry and electromyography (EMG) in smart textiles has been validated against standard commercial devices, showing accurate measurements of muscle activity and oxygen saturation in the quadriceps during exercise.

This technology allows for continuous monitoring of muscle performance during various activities, suggesting its potential use for assessing strength and endurance in different populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of Fabric-Based Thigh-Wearable EMG Sensors and Oximetry for Monitoring Quadriceps Activity during Strength and Endurance Exercises. Di Giminiani, R., Cardinale, M., Ferrari, M., et al.[2021]

The Zephyr BioHarness (ZB) device demonstrated excellent test-retest reliability for measuring respiratory rate across different conditions, including at rest, during the modified Canadian Aerobic Fitness Test (mCAFT), and throughout recovery, with intraclass correlation coefficients (ICCs) ranging from 0.76 to 0.90.

This study involved 60 participants (30 females) and confirmed that the ZB can provide stable and consistent respiratory rate measurements in a diverse group of healthy individuals, supporting its use in physiological monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of Zephyr BioHarness Respiratory Rate at Rest, During the Modified Canadian Aerobic Fitness Test and Recovery. Nazari, G., MacDermid, JC.[2021]

Current portable heart rate monitors can detect arrhythmias, but many users are unaware of this capability, highlighting a gap in consumer knowledge about their health monitoring potential.

A consensus among 92 experts suggests that the ideal heart rate monitor for endurance athletes should be a lightweight smartwatch with multiple electrodes, capable of continuous ECG recording and smartphone integration, ensuring user-friendliness and affordability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sports Heart Monitors as Reliable Diagnostic Tools for Training Control and Detecting Arrhythmias in Professional and Leisure-Time Endurance Athletes: An Expert Consensus Statement. Gajda, R., Gajda, J., Czuba, M., et al.[2023]

Wearable technology in sports medicine can effectively monitor athletes' physical performance, physiological status, and mental alertness, leading to reduced injury risks and improved performance.

The review highlights the need for collaboration between academic researchers, sports medicine clinics, and performance programs to enhance the use of wearable devices in developing athlete-centered treatment plans and return-to-play protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable sensors for monitoring the internal and external workload of the athlete. Seshadri, DR., Li, RT., Voos, JE., et al.[2023]

Wearable sensors have been effective in identifying differences in knee function between limbs after ACL reconstruction, particularly during tasks like jumping and landing, based on a review of 11 studies.

These sensors showed good reliability and agreement with traditional laboratory methods, suggesting they could be useful for monitoring rehabilitation progress, although variations in study methods indicate a need for further research to standardize practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of wearable technology as an assessment tool to identify between-limb differences during functional tasks following ACL reconstruction. A scoping review. Marques, JB., Auliffe, SM., Thomson, A., et al.[2022]

Wearable sensors are becoming increasingly important in medical and health applications, allowing for continuous monitoring of physiological signals like heart rate and movement, which can enhance the quality of medical treatment.

These devices not only track individual health metrics but also assess environmental conditions, providing valuable data for both personal health and environmental quality, indicating their versatility and potential for broader applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent developments in sensors for wearable device applications. Cheng, Y., Wang, K., Xu, H., et al.[2021]

Recent advancements in flexible wearable sensors have significantly improved the ability to monitor vital health signals such as ECG, heart rate, and body movements, which are crucial for athletic training and health management.

These wearable devices, enhanced by technologies like IoT and AI, can effectively aid in disease prediction and health monitoring, although challenges remain in ensuring compliance and addressing limitations in current sensor technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Recent Advances in Vital Signals Monitoring of Sports and Health via Flexible Wearable Sensors. Sun, W., Guo, Z., Yang, Z., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A review of current use of commercial wearable technology and smartphone apps with application in monitoring individuals following total hip replacement surgery. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Wearable Sensors and Smart Devices to Monitor Rehabilitation Parameters and Sports Performance: An Overview. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Wearable Performance Devices in Sports Medicine. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Wearable Movement Sensors for Rehabilitation: A Focused Review of Technological and Clinical Advances. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Perspectives on the prospective development of stroke-specific lower extremity wearable monitoring technology: a qualitative focus group study with physical therapists and individuals with stroke. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Validity and reliability of the Moxy oxygen monitor during incremental cycling exercise. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Validation of Fabric-Based Thigh-Wearable EMG Sensors and Oximetry for Monitoring Quadriceps Activity during Strength and Endurance Exercises. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Reliability of Zephyr BioHarness Respiratory Rate at Rest, During the Modified Canadian Aerobic Fitness Test and Recovery. [2021]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Sports Heart Monitors as Reliable Diagnostic Tools for Training Control and Detecting Arrhythmias in Professional and Leisure-Time Endurance Athletes: An Expert Consensus Statement. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Wearable sensors for monitoring the internal and external workload of the athlete. [2023]

11. England pubmed.ncbi.nlm.nih.gov

The use of wearable technology as an assessment tool to identify between-limb differences during functional tasks following ACL reconstruction. A scoping review. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

Recent developments in sensors for wearable device applications. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

A Review of Recent Advances in Vital Signals Monitoring of Sports and Health via Flexible Wearable Sensors. [2022]