Knee OsteoarthritisNCT00724139
The Effect of Training With Custom-Made Biomechanical Perturbation Platform on Kinetics, Kinematics and Electromyography in Knee Osteoarthritis Patients
A study testing : APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel in people with Knee Osteoarthritis, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The aim of this study is to evaluate the outcome of specific repetitive biomechanical perturbation training on motor patterns. The first hypothesis of this project is that footwear derived biomechanical challenges will convey active and passive matching biomechanical responses (i.e. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- : APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to May 2009
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Community-dwelling older adults.
- Symptomatic knee OA for at least 6 months, fulfilled American College of Rheumatology clinical criteria for OA of the knee and radiographically assessed osteoarthritis of the knee graded 1-2 according to the Kellgren \& Lawrence scale.
- Ambulatory and active patients that can precipitate the gait analysis.
- Age 50-75.
- No prior joint replacement in the lower extremity.
Who cannot join
- Knee pain due to pathologic conditions other than OA, such as rheumatoid arthritis and pseudogout.
- Knee with flexion contracture greater than 20°.
- Patients with hip problems, symptomatic lumbar spine disease, spinal cord.
- Ataxic gait related to neurologic disease.
- Patients with increased tendency to fall.
- Lack of physical or mental ability to perform or comply with the treatment procedure.
- Diabetes mellitus.
- History of pathological osteoporotic fracture.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Technion Israel institute of technology
Haifa
Amir Haim, MD, 0524262129, amirhaim@gmail.com
Amir Haim, MD
About this study
The aim of this study is to evaluate the outcome of specific repetitive biomechanical perturbation training on motor patterns.
The first hypothesis of this project is that footwear derived biomechanical challenges will convey active and passive matching biomechanical responses (i.e. kinetic, kinematic and electromyographic) trough out the musculoskeletal kinematic chain.
The second hypothesis of the project is that repetitive exposure to in-situ (trough out the gait sickle) introduction to a biomechanical stimulus would generate a process of motor learning thus conveying plasticity of existing locomotor patterns and gait strategies.
Read the detailed description
Design: Prospective, case control Setting: subjects will undergo a tailored training program utilizing a novel biomechanical system comprising four modular elements attached onto foot-worn platforms (APOS system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel) which conveys perturbation throughout the gait sickle. Pre and post training level walking will be examined via: (1) a three-dimensional motion analysis system and (2) ground reaction force analysis using force platforms (3) Electro-Myography system. Each subject will be examined in 4 different settings Patients will then participate in continued biomechanical perturbation training for 3-6 month and will then undergo a second gait examination Ages Eligible for Study: 50 Years - 75 Years, Genders Eligible for Study: None Accepts patients suffering from medial compartment knee osteoarthritis
- Conditions
- Knee Osteoarthritis
- Being tested
- : APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
: APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, IsraelDevice
training program utilizing a novel biomechanical system comprising four modular elements attached onto foot-worn platforms which conveys perturbation throughout the gait cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patients (aged 50-75) with Symptomatic knee OA for at least 6 months, fulfilled American College of Rheumatology clinical criteria for OA of the knee and radiographically assessed osteoarthritis of the knee graded 1-2 according to the Kellgren \& Lawrence scale. Receives: Device: : APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel |
What is being measured
The primary outcome is the main question the study is designed to answer.
footwear derived biomechanical challenges will convey active and passive matching biomechanical responses (i.e. kinetic, kinematic and electromyographic) trough out the musculoskeletal kinematic chain
Measured: 6 months
Secondary outcomes (1)
would repetitive exposure to in-situ (trough out the gait sickle) introduction to a biomechanical stimulus would generate a process of motor learning
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee 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
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724139
- Sponsor's protocol ID
- protocol # 078
- Status last verified
- Jul 2008
- First submitted
- 27 Jul 2008
- Last updated
- 29 Jul 2008
- Results posted
- No
Publications
Debbi EM, Wolf A, Goryachev Y, Rozen N, Haim A. Alterations in sagittal plane knee kinetics in knee osteoarthritis using a biomechanical therapy device. Ann Biomed Eng. 2015 May;43(5):1089-97. doi: 10.1007/s10439-014-1177-3. Epub 2014 Nov 7.
PubMed 25377767
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training With Custom-Made Biomechanical Perturbation Platform on Kinetics, Kinematics and Electromyography in Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT00724139
- Acronym / sponsor ID
- protocol # 078
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 29 Jul 2008 (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 aim of this study is to evaluate the outcome of specific repetitive biomechanical perturbation training on motor patterns.
The first hypothesis of this project is that footwear derived biomechanical challenges will convey active and passive matching biomechanical responses (i.e. kinetic, kinematic and electromyographic) trough out the musculoskeletal kinematic chain.
The second hypothesis of the project is that repetitive exposure to in-situ (trough out the gait sickle) introduction to a biomechanical stimulus would generate a process of motor learning thus conveying plasticity of existing locomotor patterns and gait strategies.
Detailed description
Design: Prospective, case control Setting: subjects will undergo a tailored training program utilizing a novel biomechanical system comprising four modular elements attached onto foot-worn platforms (APOS system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel) which conveys perturbation throughout the gait sickle. Pre and post training level walking will be examined via: (1) a three-dimensional motion analysis system and (2) ground reaction force analysis using force platforms (3) Electro-Myography system. Each subject will be examined in 4 different settings Patients will then participate in continued biomechanical perturbation training for 3-6 month and will then undergo a second gait examination Ages Eligible for Study: 50 Years - 75 Years, Genders Eligible for Study: None Accepts patients suffering from medial compartment knee osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: : APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israelpatients (aged 50-75) with Symptomatic knee OA for at least 6 months, fulfilled American College of Rheumatology clinical criteria for OA of the knee and radiographically assessed osteoarthritis of the knee graded 1-2 according to the Kellgren \& Lawrence scale. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (8 listed)
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 |
|---|---|---|
| : APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israeltraining program utilizing a novel biomechanical system comprising four modular elements attached onto foot-worn platforms which conveys perturbation throughout the gait cycle | Device | 1 |
Primary outcome
footwear derived biomechanical challenges will convey active and passive matching biomechanical responses (i.e. kinetic, kinematic and electromyographic) trough out the musculoskeletal kinematic chain
Time frame: 6 months
1 secondary outcome
would repetitive exposure to in-situ (trough out the gait sickle) introduction to a biomechanical stimulus would generate a process of motor learning
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2008.
- Derived from this study: PubMed 25377767Debbi EM, Wolf A, Goryachev Y, Rozen N, Haim A. Alterations in sagittal plane knee kinetics in knee osteoarthritis using a biomechanical therapy device. Ann Biomed Eng. 2015 May;43(5):1089-97. doi: 10.1007/s10439-014-1177-3. Epub 2014 Nov 7.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing : APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel in people with Knee 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 29 Jul 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Haim, MD (0524262129, amirhaim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
footwear derived biomechanical challenges will convey active and passive matching biomechanical responses (i.e. kinetic, kinematic and electromyographic) trough out the musculoskeletal kinematic chain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00724139, which also lists 1 linked publication.
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 29 Jul 2008.