Exercise Monitoring System for Osteoarthritis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: University of Southern Mississippi
No Placebo Group
Trial Summary
What is the purpose of this trial?Exercise is very important for living healthier and longer lives. For people with obesity and osteoarthritis, exercise is even more important because it can help them feel less pain in their joints. Also, the more intense the exercise is, the larger the health benefits will be. The most common ways to exercise are running and riding a stationary bicycle. However, these two types of exercise can cause problems for people with obesity and osteoarthritis. Fast running creates large loads in the knees because of the impact of the foot on the ground. On the other hand, studies in cycling show limited improvement in pain because cycling does not allow the feet to move freely, which is important for reducing pain in people with osteoarthritis. This study introduces a new way to exercise using a hip flexion feedback system (HFFS). The subjects will exercise by increasing how much they lift their knees while walking on treadmill. The exercise will also involve controlling the impact of the feet on the treadmill. The HFFS monitors the subject's heart rate during the exercise using a standard heart rate monitor. A TV placed in front of the treadmill shows how high individuals need to lift their knees. How much participants need to lift their knees is calculated by the HFFS based on real-time heart rate readings. Therefore, the HFFS can help people stay at a specific exercise intensity by controlling how high it tells them lift their knees during the exercise. This study will have participants with osteoarthritis and obesity in two groups. One group will exercise using the HFFS. Another group will not exercise. The exercise group will do a 12-week high intensity exercise program. Our first goal is to determine how much fitness, pain, and the ability to move improve due to the exercise program. With this study we are looking to introduce a better and safer way to exercise for people with osteoarthritis and obesity. The results of this study will also allow for further development of home-based exercise and telemedicine.
Do I need to stop taking my current medications to join the trial?The trial protocol does not specify whether you need to stop taking your current medications. However, you should discuss your medications with the study team to ensure they don't interfere with the trial.
Is the Hip Flexion Feedback System (HFFS) a promising treatment for osteoarthritis?Yes, the Hip Flexion Feedback System (HFFS) is promising because it uses wearable technology to monitor and provide feedback on joint movement, helping patients improve their physical activity and recovery.13578
What safety data exists for the Exercise Monitoring System for Osteoarthritis?The research does not provide specific safety data for the Exercise Monitoring System for Osteoarthritis or the Hip Flexion Feedback System (HFFS). However, it describes a wearable magnet-based system that measures joint flexion and physical activity, which could be related. This system was tested on humans and animals, showing feasibility in measuring joint flexion and monitoring post-operative recovery. No adverse safety issues were reported in the study, but specific safety data for the HFFS or similar systems is not detailed in the provided research.2451012
What data supports the idea that Exercise Monitoring System for Osteoarthritis is an effective treatment?The available research does not directly provide data on the effectiveness of the Exercise Monitoring System for Osteoarthritis. However, it mentions that accelerometer-based activity monitoring, which is a similar technology, can help patients in orthopaedic rehabilitation by tracking physical activity and providing feedback. This can encourage a more active lifestyle, which may be beneficial for osteoarthritis patients. Compared to other treatments, like supervised resistance training, which has been shown to improve function and quality of life for hip osteoarthritis patients, the Exercise Monitoring System might offer additional benefits by providing real-time feedback and motivation.6791113
Eligibility Criteria
This trial is for adults aged 30-75 with obesity (BMI between 30.0 and 50.0) who are sedentary, have medical clearance, and knee pain from osteoarthritis but no recent severe heart issues, joint surgeries, or certain other health conditions like dementia or terminal illnesses.Participant Groups
The study tests a hip flexion feedback system (HFFS) that guides knee-lifting exercises on a treadmill based on real-time heart rate to improve fitness and reduce pain in people with osteoarthritis and obesity compared to those not exercising.
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
This group will do a 12-week high intensity exercise program. The subjects will exercise by increasing how much they lift their knees while walking on treadmill. The exercise will also involve controlling the impact of the feet on the treadmill. A TV placed in front of the treadmill shows how high individuals need to lift their knees. How much participants need to lift their knees is calculated based on real-time heart rate readings.
Group II: ControlActive Control1 Intervention
This group will do initially a 12-week period of no intervention. After these 12 weeks, participants will do a 12-week high intensity exercise program. The subjects will exercise by increasing how much they lift their knees while walking on treadmill. The exercise will also involve controlling the impact of the feet on the treadmill. A TV placed in front of the treadmill shows how high individuals need to lift their knees. How much participants need to lift their knees is calculated based on real-time heart rate readings.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University Southern MississippiHattiesburg, MS
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Who is running the clinical trial?
University of Southern MississippiLead Sponsor
References
Ambulatory measurement of knee motion and physical activity: preliminary evaluation of a smart activity monitor. [2018]There is currently a paucity of devices available for continuous, long-term monitoring of human joint motion. Non-invasive, inexpensive devices capable of recording human activity and joint motion have many applications for medical research. Such a device could be used to quantify range of motion outside the gait laboratory. The purpose of this study was to test the accuracy of the modified Intelligent Device for Energy Expenditure and Activity (IDEEA) in measuring knee flexion angles, to detect different physical activities, and to quantify how often healthy subjects use deep knee flexion in the ambulatory setting.
Outcome after hip arthroscopy for femoroacetabular impingement in 289 patients with minimum 2-year follow-up. [2022]Femoroacetabular impingement (FAI) is a common cause of hip pain and dysfunction. The purpose of this study was to report outcome 2 years after the arthroscopic treatment of FAI using validated outcome measurements. Two hundred and eighty-nine patients (males = 190, females = 99) with a mean age of 37 years underwent arthroscopic surgery for FAI. Patients were included consecutively in a hip arthroscopy registry. The cohort was evaluated using online web-based validated health-related patient-reported outcomes measurements, including the iHOT-12, HAGOS, EQ-5D, HSAS for physical activity level, VAS for overall hip function and overall satisfaction. The mean follow-up time was 25.4 months. Pre-operative scores compared with those obtained at follow-up revealed statistically and clinically significant improvements (P
Real-time activity classification in a wearable system prototype for knee health assessment via joint sounds. [2020]An algorithm for performing activity classification for a joint health assessment system using acoustical emissions from the knee is presented. The algorithm was refined based on linear acceleration data from the shank and the thigh sampled at 100 Hz/ch and collected from eight healthy subjects performing unloaded flexion-extension and sit-to-stand motions. The algorithm was implemented on a field-programmable gate array (FPGA)-based processor and has been validated in realtime on a subject performing two minutes of activities consisting of flexion-extension, sit-to-stand, and other motions while standing. When an activity is detected, the algorithm generates an enable signal for high throughput data acquisition of knee joint sounds using two airborne microphones (100 kHz/ch) and two single-axis gyroscope and accelerometer pairs (1 kHz/ch). This approach can facilitate energy-efficient recording of joint sound signatures in the context of flexion-extension and sit-to-stand activities from freely-moving subjects throughout the day, potentially providing a means of evaluating rehabilitation status, for example, following acute knee injury.
A Wearable Magneto-Inertial System for Gait Analysis (H-Gait): Validation on Normal Weight and Overweight/Obese Young Healthy Adults. [2019]Background: Wearable magneto-inertial sensors are being increasingly used to obtain human motion measurements out of the lab, although their performance in applications requiring high accuracy, such as gait analysis, are still a subject of debate. The aim of this work was to validate a gait analysis system (H-Gait) based on magneto-inertial sensors, both in normal weight (NW) and overweight/obese (OW) subjects. The validation is performed against a reference multichannel recording system (STEP32), providing direct measurements of gait timings (through foot-switches) and joint angles in the sagittal plane (through electrogoniometers). Methods: Twenty-two young male subjects were recruited for the study (12 NW, 10 OW). After positioning body-fixed sensors of both systems, each subject was asked to walk, at a self-selected speed, over a 14-m straight path for 12 trials. Gait signals were recorded, at the same time, with the two systems. Spatio-temporal parameters, ankle, knee, and hip joint kinematics were extracted analyzing an average of 89 ± 13 gait cycles from each lower limb. Intraclass correlation coefficient and Bland-Altmann plots were used to compare H-Gait and STEP32 measurements. Changes in gait parameters and joint kinematics of OW with respect NW were also evaluated. Results: The two systems were highly consistent for cadence, while a lower agreement was found for the other spatio-temporal parameters. Ankle and knee joint kinematics is overall comparable. Joint ROMs values were slightly lower for H-Gait with respect to STEP32 for the ankle (by 1.9° for NW, and 1.6° for OW) and for the knee (by 4.1° for NW, and 1.8° for OW). More evident differences were found for hip joint, with ROMs values higher for H-Gait (by 6.8° for NW, and 9.5° for OW). NW and OW showed significant differences considering STEP32 (p = 0.0004), but not H-Gait (p = 0.06). In particular, overweight/obese subjects showed a higher cadence (55.0 vs. 52.3 strides/min) and a lower hip ROM (23.0° vs. 27.3°) than normal weight subjects. Conclusions: The two systems can be considered interchangeable for what concerns joint kinematics, except for the hip, where discrepancies were evidenced. Differences between normal and overweight/obese subjects were statistically significant using STEP32. The same tendency was observed using H-Gait.
A Wearable Magnet-Based System to Assess Activity and Joint Flexion in Humans and Large Animals. [2019]Functional outcomes, such as joint flexion and gait, are important indicators of efficacy in musculoskeletal research. Current technologies that objectively assess these parameters, including visual tracking systems and force plates, are challenging to deploy in long-term translational and clinical studies. To that end, we developed a wearable device that measures both physical activity and joint flexion using a single integrated sensor and magnet system, and hypothesized that it could evaluate post-operative functional recovery in an unsupervised setting. To demonstrate the feasibility of measuring joint flexion, we first compared knee motion from the wearable device to that acquired from a motion capture system to confirm that knee flexion measurements during normal human gait, predicted via changes in magnetic field strength, closely correlated with data acquired by motion capture. Using this system, we then monitored a porcine cohort after bilateral stifle arthrotomy to investigate longitudinal changes in physical activity and joint flexion. We found that unsupervised activity declined immediately after surgery, with a return to pre-operative activity occurring over a period of 2 weeks. By providing objective, individualized data on locomotion and joint function, this magnet-based system will facilitate the in vivo assessment of novel therapeutics in translational orthopaedic research.
The Effect of Simultaneous Antigravity Treadmill Training and Electrical Muscle Stimulation After Total Hip Arthroplasty: Short Follow-Up Time. [2020]To assess the effectiveness of our devised hybrid physiotherapy regime using an anti-gravity treadmill and a low-frequency electrical stimulation device, as measured in patients with hip osteoarthritis after total hip arthroplasty (THA).
Use of accelerometer-based activity monitoring in orthopaedics: benefits, impact and practical considerations. [2020]Studies of the effectiveness of orthopaedic interventions do not generally measure physical activity (PA). Applying accelerometer-based activity monitoring in orthopaedic studies will add relevant information to the generally examined physical function and pain assessment.Accelerometer-based activity monitoring is practically feasible in orthopaedic patient populations, since current day activity sensors have battery time and memory to measure continuously for several weeks without requiring technical expertise.The ongoing development in sensor technology has made it possible to combine functional tests with activity monitoring.For clinicians, the application of accelerometer-based activity monitoring can provide a measure of PA and can be used for clinical comparisons before and after interventions.In orthopaedic rehabilitation, accelerometer-based activity monitoring may be used to help patients reach their targets for PA and to coach patients towards a more active lifestyle through direct feedback. Cite this article: EFORT Open Rev 2019;4:678-685. DOI: 10.1302/2058-5241.4.180041.
Wearable Sensor Array Design for Spine Posture Monitoring During Exercise Incorporating Biofeedback. [2021]Physical therapy (PT) exercise is an evidence-based intervention for non-specific chronic low back pain, spinal deformities and poor posture. Home based PT programs are aimed at strengthening core muscle groups, improving mobility and flexibility, and promoting proper posture. However, assessing unsupervised home-based PT outcomes is a generally difficult problem due to lack of reliable methods to monitor execution correctness and compliance. We propose a monitoring method consisting of a wearable sensor array to monitor three geodesic distances between two points on the surface of the shoulders and one point on the lower back. The sensor array may be built into a custom garment or a light weight harness wirelessly linked to a pattern recognition algorithm implemented in a mobile app. We use a new type of triangular stretch sensor array design which can generate a unique signature for a correct spine therapy exercise when performed by a specific subject. We conducted a pilot test consisting of three experiments: (i) two exercise patterns simulated by a mechanical device, (ii) one PT case of a scoliosis therapy exercise including spinal flexion, extension, and rotation performed by one volunteer patient, and (iii) a set of three lower back flexibility exercises performed by six subjects. Overall, the results of correctness recognition show 70-100% sensitivity and 100% specificity. The pilot test provides key data for further development including clinical trials. The significance of the method includes simplicity of design and training method, ability to test with simulated signals, and potential to provide real time biofeedback.
Effectiveness of supervised resistance training for patients with hip osteoarthritis - a systematic review. [2021]The overall effectiveness of supervised progressive resistance training among patients with hip osteoarthritis is only scarcely investigated. The objective of this study was to estimate the effectiveness of supervised progressive resistance training compared with common treatment for patients with hip osteoarthritis, focusing on patient-reported function, pain, health-related quality of life, performance-based function at end of treatment and patient-reported function at 6-12 months.
Comparison of Lower Extremity Kinematics during the Overhead Deep Squat by Functional Movement Screen Score. [2022]It is unclear if the Functional Movement Screen (FMS) scoring criteria identify kinematics that have been associated with lower extremity injury risk. The purpose was to compare lower extremity kinematics of the overhead deep squat (OHDS) during the FMS between individuals who were grouped on FMS scoring. Forty-five adults who were free of injury and without knowledge of the FMS or its scoring criteria (males = 19, females = 26; height = 1.68 0.08 m; mass = 70.7 7 13.0 kg). Three-dimensional lower extremity kinematics during an OHDS were measured using a motion capture system. One-way MANOVA was used to compare kinematic outcomes (peak hip flexion angle, hip adduction angle, knee flexion angle, knee abduction angle, knee internal rotation angle, and ankle dorsiflexion angle) between FMS groups. Those who scored a 3 had greater peak hip flexion angle (F2,42 = 8.75; p = 0.001), knee flexion angle (F2,42 = 13.53; p = 0.001), knee internal rotation angle (F2,42 = 12.91; p = 0.001), and dorsiflexion angle (F2,42 = 9.00; p = 0.001) compared to those who scored a 2 or a 1. However, no differences were found in any outcome between those who scored a 2 and those who scored a 1, or in frontal plane hip or knee kinematics. FMS scoring for the OHDS identified differences in squat depth, which was characterized by larger peak hip, knee, and dorsi- flexion angles in those who scored a 3 compared with those who scored 2 or 1. However, no differences were found between those who scored a 2 or 1, and caution is recommended when interpreting these scores. Despite a different FMS score, few differences were observed in frontal or transverse plane hip and knee kinematics, and other tasks may be needed to assess frontal plane kinematics.
Mid-term outcomes of exercise therapy for the non-surgical management of femoroacetabular impingement syndrome: are short-term effects persisting? [2022]To investigate the mid-term outcomes of exercise therapy in patients with femoroacetabular impingement syndrome (FAIS).
Validation of the Brazilian version of the Hip Sports Activity Scale (HSAS) for patients with femoroacetabular impingement: a cross-sectional study. [2023]The Hip Sports Activity Scale (HSAS) is a hip-specific instrument for assessing the present levels of physical activity among patients with femoroacetabular impingement (FAI) syndrome. When evaluating treatment outcomes in patients with FAI syndrome, it is necessary to use joint-specific instruments and ones that can evaluate the levels of physical activity in these patients, such as the HSAS-Brazil.
Effectiveness of Interventions Aimed at Changing Movement Patterns in People With Patellofemoral Pain: A Systematic Review With Network Meta-analysis. [2023]OBJECTIVE: To summarize the effectiveness of interventions for changing movement during weight-bearing functional tasks in people with patellofemoral pain (PFP). DESIGN: Systematic review with network meta-analysis (NMA). LITERATURE SEARCH: Medline, Embase, CINAHL, SPORTDiscus, and Cochrane Library were searched from inception up to May 2023. STUDY SELECTION CRITERIA: Randomized controlled trials involving people with PFP and nonsurgical, nonpharmacological interventions on task kinematics were included. DATA SYNTHESIS: NMA was conducted for frontal knee movement data, and pairwise meta-analysis was used to pool data when NMA was not possible. Reduced movements were those changes that indicated movements occurring with less amplitude. The GRADE approach was used to grade the certainty of the evidence. RESULTS: Thirty-seven trials were included (n = 1235 participants). Combining knee/hip exercises with internal feedback had the strongest effect on reducing frontal knee movements (standardized mean difference [SMD] from NMA = -2.66; GRADE: moderate evidence). On pairwise comparisons, the same combination of interventions reduced frontal hip movements (SMD = -0.47; GRADE: moderate evidence) and increased sagittal knee movements (SMD = 1.03; GRADE: moderate evidence), with no effects on sagittal hip movements (GRADE: very low evidence), compared to knee/hip exercises alone. There was no effect for single applications of braces on the frontal knee movement (GRADE: very low evidence) and taping on movements of the knee, hip, and ankle (GRADE: very low to low evidence) compared to no intervention. CONCLUSION: Knee/hip exercises combined with internal feedback techniques may change knee and hip movements in people with PFP. The combination of these interventions can reduce frontal knee and hip movements, and can increase sagittal knee movements. J Orthop Sports Phys Ther 2023;53(12):1-13. Epub 14 September 2023. doi:10.2519/jospt.2023.11956.