PBOmd partners with leaders in therapeutic innovation to ensure patient outcomes are rigorously tracked, analyzed, and optimized. Our collaboration with
ERMI (End Range of Motion Improvement) highlights the crucial role of comprehensive clinical data gathering in validating and advancing non-surgical joint mobility restoration.
ERMI is renowned for providing specialized mechanical therapy devices, such as the Flexionater and Extensionater systems, designed to treat joint contracture (arthrofibrosis) and motion loss across the knee, shoulder, ankle, elbow, great toe, and forearm/wrist.
ERMI's methodology is rooted in the "Total End Range Time (TERT) protocol", which dictates that lasting gains in motion require maximizing the product of stretching intensity, duration, and frequency. To prove that their devices successfully achieve the plastic deformation necessary for permanent tissue elongation,
ERMI utilizes a robust system (referred to herein as the clinical data gathering process) to collect and analyze information on patient progress and clinical efficacy.
The process involves gathering and reviewing large datasets of patient records to analyze performance and compare results against traditional treatments:
- Massive Patient Cohorts: ERMI has conducted large-scale retrospective reviews drawing on data from thousands of patients. For instance, one study investigated the efficacy of high-intensity stretch (HIS) therapy using records from **over 11,000 knee patients** to regain flexion loss. Another study reviewed records from 15,133 patients to assess shoulder motion outcomes.
- Detailed Clinical Data Collection: Clinical information is collected from multiple sources, including ERMI's internal database and detailed data extracted from physical therapy progress notes and reports generated for physicians or payors.
-
Key Outcome Measures: The clinical information gathered focuses on objective measures of recovery and health economics:
-
Range of Motion (ROM): Data points include initial and last recorded ROM measurements (e.g., knee flexion, shoulder external rotation, abduction, and forward flexion). These ROM measurements are often taken by a physical therapist using a goniometer.
-
Patient-Reported Outcome Measures (PROMs): Studies analyze functional scores like the American Shoulder and Elbow Surgeons (ASES) scores and Simple Shoulder Test (SST) scores for shoulder patients, and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Scale) for knee patients.
-
Treatment Parameters: Information includes the duration of use (often achieved in 2 months or less for knee flexion therapy), device usage dates, and patient demographics such as age, sex, and workers' compensation status.
The comprehensive clinical information gathered allows ERMI to demonstrate the efficacy and value of its High-Intensity Stretch (HIS) devices:
| Clinical Area | Outcome Measured | Key Insight from Data Analysis |
| Knee Flexion | ROM Gain | Patients achieved significant flexion gains, averaging nearly 30 degrees in under 8 weeks of treatment. |
| Functional Recovery (Knee) | Final ROM | The average last recorded knee flexion reached a level above the degree needed to complete activities of daily living. | |
| Surgery Avoidance (Knee) | Secondary Intervention Rate | Studies have shown a 90% success rate in patients avoiding additional surgery for severe knee flexion loss. | |
| Surgery Avoidance (Shoulder) | Secondary Intervention Rate | 97% of patients who used the Shoulder Flexionater were able to avoid additional surgery to treat motion loss. | |
| Shoulder ROM Gain | ROM Gain | Shoulder Flexionater patients gained an average of 29.9 degrees in external rotation and 40.5 degrees in abduction in under 9 weeks. |
| Cost Effectiveness (Knee) | Medical Costs/Re-operation Risk | Use of the ERMI Knee Flexionater resulted in nearly $9,000 savings per patient compared to low-intensity therapy, primarily driven by a significantly reduced re-hospitalization rate. Patients using PT alone were almost twice as likely to require reoperation compared to those treated with the ERMI device. |
| Worker's Compensation | Treatment Efficacy | Clinical data showed that workers’ compensation patients achieved equivalent results as non-workers’ compensation patients when using the Ermi Knee Extensionater for loss of extension. This success was also seen in flexion therapy, with no significant differences in outcomes between the two groups. |
| Managed Care (Knee) | Post-Index Knee-Attributable Medical Costs (KAMC) | Multivariate analysis showed post-index KAMC were lower for HIS patients, with Low Intensity Stretch (LIS) patients incurring 24% higher costs (p = 0.025) and Physical Therapy alone ("No Device") patients incurring 9% higher costs relative to HIS patients. |
| Managed Care (Knee) | Risk of Subsequent Knee Event | Patients treated with Physical Therapy alone ("No Device" group) were 71% more likely (p < 0.0001) to have a subsequent knee event compared to HIS patients. |
| Shoulder (Adhesive Capsulitis) | Pain Management / Secondary Procedures | Only HIS-treated patients (used alone or combined with PT) maintained pain control, with 30% of PT-only patients requiring additional corticosteroid injection beyond 6 months follow-up, compared to 0% in the HIS-only group. |
This information is crucial for an EMR company collecting research data because it establishes the precise scientific foundation and necessary data points for validating the efficacy of therapeutic devices like the ERMI Flexionater and Extensionater systems
which fall into the category of stationary, non-electric, hydraulically amplified, stretch assist machines. These devices drive tissue remodeling and permanent range of motion (ROM) gains based on the following mechanistic principles:
Mechanistic Drive of Permanent ROM Gains
-
Achieving Plastic Deformation: To permanently improve flexibility or joint range of motion in the long term, tissues like ligaments, capsular connections, or injury-related scar tissue must become permanently stretched, thus increasing their length and creating an increase in range of motion. Soft tissues, like an elastic band, respond to stress either elastically or plastically.
-
When stretched within the elastic region, the tissue returns to its original length once tension is removed.
-
To achieve permanent lengthening and ROM increase, the tissue must be pulled further into the plastic region, past the yield point.
-
The TERT Protocol and Dose Dependence: Stretching aimed at permanent ROM improvement is dose-dependent, determined by the intensity, duration, and frequency of the stretch.
-
Total End Range Time (TERT) describes the total amount of time a patient spends stretching a joint at the end of its restricted range of motion.
-
Increased TERT results in greater lengthening of the ligament, capsular, and tendon tissues, leading to increased range of motion.
-
The ERMI Flexionater, as a non-electric, hydraulically amplified machine, allows the patient to control the pressure applied to the contracted joint with their normal extremity, enabling them to "feel" the amount of pressure created. This personalized application of force helps achieve the necessary dose without causing injury.
-
Viscoelastic Principles (Low-Load Prolonged Stretch): The ERMI system implements techniques like Patient Actuated Serial Stretch (PASS). The principles of Low-Load Prolonged Stretch (LLPS) are key to overcoming tissue stiffness.
-
The tight tissues around a joint are viscoelastic. They respond differently depending on how quickly or slowly the load is applied.
-
A slow stretch, characteristic of these stretch-assist devices, may lower the yield point, allowing lasting improvements in range of motion.
-
PASS sessions are typically short (5–10 minutes) spread out multiple times per day (e.g., 6 times per day), which allows for ideal tissue remodeling without stimulating an inflammatory response.
-
Guiding Cellular Remodeling: The goal of using mechanical stress during the remodeling phase is to guide the biological processes that dictate tissue structure.
-
Stretching provides the stress that guides the cellular response for collagen alignment, type selection, and differentiation, facilitating joint recovery during the Remodeling Phase of healing.
-
The collagen laid down during the proliferation phase is initially random, resembling a pliable, low-strength mat of hair.
-
Appropriate mechanical stress causes the collagen fibers to become increasingly organized, aligning in the direction of strain.
-
The early, more elastic Type III collagen is resorbed and replaced with Type I collagen, which has greater cross-linking and tensile strength, producing a stiffer, more organized fibrotic extracellular matrix over time.
-
Introducing controlled stretching around 4–6 weeks after surgery or injury is optimal because the scar tissue is strong enough to withstand loading, yet macrophages and myofibroblasts are still present and responsive to mechanical cues, guiding proper alignment and reducing the risk of motion-limiting scar tissue.
The ongoing collection and analysis of this clinical information underscore the conclusion that HIS mechanical therapy is an effective non-surgical approach for patients who are at risk for a secondary motion loss surgery. ERMI devices are stationary stretch assist machines that utilize specialized methods, such as Patient Actuated Serial Stretch (PASS), to maximize stretch time at the end range of motion, delivering a high-intensity controlled stretch comparable to the force a physical therapist applies. This process validates ERMI's mission to restore function without requiring motion restoring surgery because by using specialized devices like the Flexionater to consistently deliver the required dose (TERT), ERMI facilitates the necessary plastic deformation and cellular restructuring to permanently restore joint mobility.
To learn more, take a
Quick Tour or
Contact Us 
Username: 
Password: 
Office Code: 
