Knee ArthroplastyNCT01412814
Biomechanics of Gait Pattern Adaptation in Patients After Total Knee Arthroplasty
A study testing AposTherapy Biomechanical System and Physical Therapy Program in people with Knee Arthroplasty and Knee Arthritis Osteoarthritis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This study aimed to discover the biomechanics of gait pattern adaptation in patients after a total knee replacement. The first hypothesis of the project was that center-of-pressure manipulation at the foot during dynamic loading is capable of changing the forces, torques and muscle activation patterns of the lower… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Knee Arthroplasty, Knee Arthritis Osteoarthritis, Osteoarthritis
- What is being tested?
- AposTherapy Biomechanical System and Physical Therapy Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for first total knee arthroplasty due to end-stage knee osteoarthritis
- Ambulatory and active patients that can participate in gait analysis
Who cannot join
- Prior joint surgery of either lower extremity, with the exception of arthroscopy
- Unsteady gait
- Back pain
- Neurological, pulmonary or cardiovascular pathologies or risks that may affect long-term performance
- Inability to understand or comply with the treatment protocol
Trial locations and contacts
1 site in 1 country.
Israel1 site
Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology
Haifa, Israel
About this study
This study aimed to discover the biomechanics of gait pattern adaptation in patients after a total knee replacement.
The first hypothesis of the project was that center-of-pressure manipulation at the foot during dynamic loading is capable of changing the forces, torques and muscle activation patterns of the lower limb.
The second hypothesis of the project was that patient-specific center-of-pressure manipulation at the foot combined with repetitive perturbation training over time will improve neuromuscular function, barefoot gait patterns, muscle activation patterns, pain, quality of life and energy consumption in patients after a total knee replacement.
Read the detailed description
This study is a randomized prospective controlled study of patients after total knee arthroplasty. Patients will be recruited to the study and divided randomly into an experimental and control group. Both groups will match in terms of gender, age, pathology and clinical assessment. In addition to the intervention of the present study, all patients, whether in the experimental or control group, will carry out the usual physical therapy exercises for total knee arthroplasty as directed by their physician. The patients will be recruited and evaluated prior to surgery and for a follow-up period after surgery.
After surgery, patients in the experimental group will be fitted with a customized biomechanical device worn on the feet (Apos System, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel). The device is calibrated personally to each patient. By calibrating the device, the center-of-pressure of the foot can be manipulated during all phases of the gait cycle. The device is capable of inducing controlled perturbation during gait. The immediate effects of the device will be evaluated using center-of-pressure measurements, three-dimensional gait analyses and surface electromyography. The patients are instructed to walk with the device according to a therapy protocol (AposTherapy). Patients will be evaluated for changes in gait via three-dimensional gait analyses, muscle activation pattern changes via surface electromyography, pain, quality of life and energy consumption.
The patients in the control group will carry out the same walking exercises as the experimental group, but without the biomechanical intervention device (placebo walking shoe). The patients will be evaluated with the same tools over time as with the experimental group.
- Conditions
- Knee Arthroplasty, Knee Arthritis Osteoarthritis, Osteoarthritis, Osteoarthritis, Knee, Musculoskeletal Diseases
- Being tested
- AposTherapy Biomechanical System, Physical Therapy Program
- Keywords
- Total knee arthroplasty, Total knee replacement, End-stage knee osteoarthritis, Gait patterns, Neuromuscular education
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AposTherapy Biomechanical SystemDevice
The device is 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.
Physical Therapy ProgramOther
Their therapy program will be similar to the experimental group, but without the treatment device (placebo walking shoe).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | These patients will carry out the specified intervention of the study with the AposTherapy Biomechanical System in addition to the typical physical therapy regiment prescribed to them by their physician. Receives: Device: AposTherapy Biomechanical System |
| Control | Active comparator | The patients within this group will also carry out the typical physical therapy program for total knee replacement as prescribed by their physician. The patients will carry out a similar therapy program to the experimental group, but without the study intervention device (placebo walking shoe). Receives: Other: Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Gait Patterns at 6-8 weeks, 5-6 months and 11-12 months
Three-dimensional gait analysis of spatiotemporal, kinetic and kinematic parameters.
Surface electromyographic analysis of muscle activation patterns. Center of pressure measurements and function tests.
Measured: An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery
Secondary outcomes (1)
Change from Baseline in Pain, Function and Quality of Life Assessments at 6-8 weeks, 5-6 months and 11-12 months
Includes self-evaluation questionnaires
Measured: An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionOct 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 Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412814
- Sponsor's protocol ID
- TASMC 11 MS 0569-10-TLV CTIL
- Other IDs
- 0569-10-TLV
- Status last verified
- Dec 2015
- First submitted
- 20 Jul 2011
- Last updated
- 22 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanics of Gait Pattern Adaptation in Patients After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01412814
- Acronym / sponsor ID
- TASMC 11 MS 0569-10-TLV CTIL
- Conditions
- Knee Arthroplasty, Knee Arthritis Osteoarthritis, Osteoarthritis, Osteoarthritis, Knee, Musculoskeletal Diseases
- Keywords
- Total knee arthroplasty, Total knee replacement, End-stage knee osteoarthritis, Gait patterns, Neuromuscular education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Aug 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.
This study aimed to discover the biomechanics of gait pattern adaptation in patients after a total knee replacement.
The first hypothesis of the project was that center-of-pressure manipulation at the foot during dynamic loading is capable of changing the forces, torques and muscle activation patterns of the lower limb.
The second hypothesis of the project was that patient-specific center-of-pressure manipulation at the foot combined with repetitive perturbation training over time will improve neuromuscular function, barefoot gait patterns, muscle activation patterns, pain, quality of life and energy consumption in patients after a total knee replacement.
Detailed description
This study is a randomized prospective controlled study of patients after total knee arthroplasty. Patients will be recruited to the study and divided randomly into an experimental and control group. Both groups will match in terms of gender, age, pathology and clinical assessment. In addition to the intervention of the present study, all patients, whether in the experimental or control group, will carry out the usual physical therapy exercises for total knee arthroplasty as directed by their physician. The patients will be recruited and evaluated prior to surgery and for a follow-up period after surgery.
After surgery, patients in the experimental group will be fitted with a customized biomechanical device worn on the feet (Apos System, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel). The device is calibrated personally to each patient. By calibrating the device, the center-of-pressure of the foot can be manipulated during all phases of the gait cycle. The device is capable of inducing controlled perturbation during gait. The immediate effects of the device will be evaluated using center-of-pressure measurements, three-dimensional gait analyses and surface electromyography. The patients are instructed to walk with the device according to a therapy protocol (AposTherapy). Patients will be evaluated for changes in gait via three-dimensional gait analyses, muscle activation pattern changes via surface electromyography, pain, quality of life and energy consumption.
The patients in the control group will carry out the same walking exercises as the experimental group, but without the biomechanical intervention device (placebo walking shoe). The patients will be evaluated with the same tools over time as with the experimental group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: AposTherapy Biomechanical SystemThese patients will carry out the specified intervention of the study with the AposTherapy Biomechanical System in addition to the typical physical therapy regiment prescribed to them by their physician. |
| Control | Active comparator | Other: Physical Therapy ProgramThe patients within this group will also carry out the typical physical therapy program for total knee replacement as prescribed by their physician. The patients will carry out a similar therapy program to the experimental group, but without the study intervention device (placebo walking shoe). |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for first total knee arthroplasty due to end-stage knee osteoarthritis
- Ambulatory and active patients that can participate in gait analysis
Key exclusion criteria (5 listed)
- Prior joint surgery of either lower extremity, with the exception of arthroscopy
- Unsteady gait
- Back pain
- Neurological, pulmonary or cardiovascular pathologies or risks that may affect long-term performance
- Inability to understand or comply with the treatment protocol
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 device is 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 |
| Physical Therapy ProgramTheir therapy program will be similar to the experimental group, but without the treatment device (placebo walking shoe). | Other | Control |
Primary outcome
Change from Baseline in Gait Patterns at 6-8 weeks, 5-6 months and 11-12 months
Time frame: An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery
Three-dimensional gait analysis of spatiotemporal, kinetic and kinematic parameters. Surface electromyographic analysis of muscle activation patterns. Center of pressure measurements and function tests.
1 secondary outcome
Change from Baseline in Pain, Function and Quality of Life Assessments at 6-8 weeks, 5-6 months and 11-12 months
Time frame: An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery
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 22 Dec 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 and Physical Therapy Program in people with Knee Arthroplasty and Knee Arthritis Osteoarthritis, run by Tel-Aviv Sourasky Medical Center 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 2 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 22 Dec 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 6-8 weeks, 5-6 months and 11-12 months (time frame: An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery). 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 22 Dec 2015.