- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01450254
Effects of Foot Center of Pressure Manipulation on Hip Osteoarthritis Patients During Gait
Effects of Foot Center of Pressure Manipulation on Hip Biomechanics, Muscle Activation Patterns, and Energy Consumption During Gait in Hip Osteoarthritis Patients
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:
- Gait parameters (spatiotemporal, kinematic, and kinetic)
- Muscle activation patterns of the lower limbs and back
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:
- Gait parameters (spatiotemporal, kinematic, and kinetic)
- Motor learning and muscle activation patterns
- Energy consumption
- Pain, physical function, and quality of life
The hypotheses of the study, in reference to the aforementioned study objectives are:
- Changes in foot center of pressure will have an immediate effect on gait parameters and muscle activation patterns of the lower limbs and back.
- Long-term manipulation of foot center of pressure, as a result of a year-long rehabilitation program using the AposTherapy Biomechanical System, will result in improvement in gait parameters, changes in muscle activation patterns as a result of new motor learning, improvement in energy consumption, decrease in pain, improvement in physical function, and improvement in quality of life.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Haifa, Israel
- Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women age 50 and over with unilateral or bilateral idiopathic hip osteoarthritis
Exclusion Criteria:
- Previous surgery on the lower limbs or back
- Previous musculoskeletal injuries and/or diseases of the lower limbs or back
- Cognitive disabilities and/or inability to cooperate or understand study instructions
- Vestibular problems and/or use of a walking aid
- Neurological and/or orthopaedic and/or cardiovascular and/or pulmonary disorders or risks that may impact the patient's functional performance or limit exercise
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
These patients will carry out a therapy program with the study intervention device.
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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.
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Active Comparator: Control
The patients in this group will not carry out a therapy program with the study intervention device.
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No intervention will be prescribed to the control group during participation in the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Gait Patterns at 3 months, 6 months, and 12 months
Time Frame: From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months
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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
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Change from Baseline in Muscle Activation Patterns at 3 months, 6 months, and 12 months
Time Frame: From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months
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Surface electromyographic analysis of muscle activation patterns.
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From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Physical Function at 3 months, 6 months, and 12 months
Time Frame: From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months
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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
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Change from Baseline in Pain at 3 months, 6 months, and 12 months
Time Frame: From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months
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Self-evaluation questionnaires.
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From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months
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Change from Baseline in Quality of Life Assessments at 3 months, 6 months, and 12 months
Time Frame: From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months
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Self-evaluation questionnaires.
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From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0091-11-EMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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