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The purpose of this study is to:
Analyze the short-term effects of external center of pressure manipulation of the foot in idiopathic hip osteoarthritis patients during gait on:
Analyze the long-term effects (during the period of one year) of external center of pressure manipulation of the foot in idiopathic hip osteoarthritis patients during gait on:
The hypotheses of the study, in reference to the aforementioned study objectives are:
This study is a randomized prospective controlled study assessing the short and long-term effects of external foot center-of-pressure manipulation on gait pattern, muscle activation pattern, energy consumption, physical function, pain, and quality of life. Sixty patients will be recruited for the study and divided randomly into two groups, an experimental group (thirty patients) and a control group (thirty patients). Both groups will be similar with respect to demographic and pathological profiles.
The experimental group will be fitted with a customized biomechanical device worn on the feet (AposTherapy Biomechanical System, AposTherapy - Sports and Medical Technologies Ltd., Hertzlia, Israel). The device is custom calibrated for each patient. The device allows center of pressure manipulation for all phases of the gait cycle and induces controlled perturbation during gait. The immediate effects of the device will be evaluated using center of pressure measurements, three-dimensional gait analysis, and surface electromyography. Following this, patients will be instructed to walk with the device at home on a daily basis according to a customized AposTherapy therapy protocol. They will return to the laboratory for measurements of gait pattern, muscle activation pattern, energy consumption, physical function, pain, and quality of life after three months, six months, and twelve months from the start of the therapy protocol. Data from the analyses will be used to reveal potential changes in the aforementioned measurements as a result of the study intervention.
The control group will carry out the same measurements in the laboratory over the period of one year, however without the biomechanical intervention device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | These patients will carry out a therapy program with the study intervention device. |
|
| Control | Active Comparator | The patients in this group will not carry out a therapy program with the study intervention device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AposTherapy Biomechanical System | Device | The system is a rehabilitation program implementing a device comprised of four adjustable modular elements attached to foot-worn platforms that are capable of manipulating the foot's center of pressure and applying perturbation training throughout the gait cycle. The device allows for neuromuscular training during dynamic loading. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Gait Patterns at 3 months, 6 months, and 12 months | Three-dimensional gait analysis of spatiotemporal, kinetic, and kinematic parameters. Center of pressure measurements. | From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months |
| Change from Baseline in Muscle Activation Patterns at 3 months, 6 months, and 12 months | Surface electromyographic analysis of muscle activation patterns. | From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Physical Function at 3 months, 6 months, and 12 months | Self-evaluation questionnaires. Physical function tests. Energy consumption measurements. | From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months |
| Change from Baseline in Pain at 3 months, 6 months, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology | Haifa | Israel |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Control | Other | No intervention will be prescribed to the control group during participation in the study. |
|
Self-evaluation questionnaires. |
| From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months |
| Change from Baseline in Quality of Life Assessments at 3 months, 6 months, and 12 months | Self-evaluation questionnaires. | From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months |
| D012216 |
| Rheumatic Diseases |