Hip OsteoarthritisNCT01450254
Effects of Foot Center of Pressure Manipulation on Hip Osteoarthritis Patients During Gait
A study testing AposTherapy Biomechanical System in people with Hip Osteoarthritis, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The purpose of this study is to: 1. Analyze the short-term effects of external center of pressure manipulation of the foot in idiopathic hip osteoarthritis patients during gait on: 1. Gait parameters (spatiotemporal, kinematic, and kinetic) 2. Muscle activation patterns of the lower limbs and back 2. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- AposTherapy Biomechanical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women age 50 and over with unilateral or bilateral idiopathic hip osteoarthritis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology
Haifa
About this study
Official title: 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
Read more
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.
Read the 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.
- Conditions
- Hip Osteoarthritis
- Being tested
- AposTherapy Biomechanical System, Control
- Keywords
- Hip Osteoarthritis, Gait Patterns, Neuromuscular retraining
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AposTherapy Biomechanical SystemDevice
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.
ControlOther
No intervention will be prescribed to the control group during participation in the study.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | These patients will carry out a therapy program with the study intervention device. Receives: Device: AposTherapy Biomechanical System |
| Control | Active comparator | The patients in this group will not carry out a therapy program with the study intervention device. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months
Secondary outcomes (3)
Change from Baseline in Physical Function at 3 months, 6 months, and 12 months
Self-evaluation questionnaires.
Physical function tests.
Energy consumption measurements.
Measured: 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
Self-evaluation questionnaires.
Measured: 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.
Measured: From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startAug 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450254
- Sponsor's protocol ID
- 0091-11-EMC
- Status last verified
- Jul 2015
- First submitted
- 3 Oct 2011
- Last updated
- 7 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Foot Center of Pressure Manipulation on Hip Biomechanics, Muscle Activation Patterns, and Energy Consumption During Gait in Hip Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT01450254
- Acronym / sponsor ID
- 0091-11-EMC
- Conditions
- Hip Osteoarthritis
- Keywords
- Hip Osteoarthritis, Gait Patterns, Neuromuscular retraining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: AposTherapy Biomechanical SystemThese patients will carry out a therapy program with the study intervention device. |
| Control | Active comparator | Other: ControlThe patients in this group will not carry out a therapy program with the study intervention device. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women age 50 and over with unilateral or bilateral idiopathic hip osteoarthritis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AposTherapy Biomechanical SystemThe 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. | Device | Experimental |
| ControlNo intervention will be prescribed to the control group during participation in the study. | Other | Control |
Primary outcome
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
Three-dimensional gait analysis of spatiotemporal, kinetic, and kinematic parameters. Center of pressure measurements.
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
Surface electromyographic analysis of muscle activation patterns.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AposTherapy Biomechanical System in people with Hip Osteoarthritis, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.