Idiopathic Parkinson's DiseasePhase 2NCT00498758
The APOS System: Effects on Gait, Mobility and QOL in Patients With Parkinson's Disease
A Phase 2 study testing APOS System - biomechanical wedge shoe in people with Idiopathic Parkinson's Disease, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The purpose of this study is to evaluate the benefits of a biomechanical wedge system - The APOS system, for improving the stability of gait, mobility and quality of life in Parkinson's disease patients. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- APOS System - biomechanical wedge shoe
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Aug 2008
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's disease
- Stage 2-3 Hoehn \& Yahr
Who cannot join
- Peripheral neuropathic pain
- Dementia
- Severe orthopaedic condition
- c.v.a
- Hearing or vision loss
- Usage of walking aid
Trial locations and contacts
No sites are listed yet.
Talia Herman contact
Yael Rotem-Galili contact
About this study
The purpose of this study is to evaluate the benefits of a biomechanical wedge system - The APOS system, for improving the stability of gait, mobility and quality of life in Parkinson's disease patients.
Read the detailed description
Recently, a biomechanical wedge system was developed for gait and balance training among patients suffering from gait disorders. The APOS system (APOS Medical \& Sports Technologies Ltd, Hertzeliya, Israel) applies special semispherical shoes, with individually adjusted implants, to improve age- and disease-related loss in muscle strength and neuromuscular control. The semispherical rubber devices that are placed on the soles of the shoes at the hind-foot and mid-foot can be moved medially, laterally, forwards and backwards. The system can be individually adjusted in order to optimally balance loading and re-train postural control during gait. An additional advantage of this treatment approach is the extraordinary compliance. The system is easily adjusted, maintained, and allows safe gait training.
After randomization, all subjects will be fitted with the APOS system, These shoes alter the dynamic balance during all gait cycle phases, adjusting the center of gravity and training postural control.
The precise location of the two wedges is adjusted individually by expert trainers using standardized protocols. Subjects in the intervention group will receive a proper wedge; subjects in the sham group will receive an almost flat wedge that lacks the proper biomechanical characteristics. However, both shoes and wedges will look similar. All subjects will be instructed to start gradually, with a goal of reaching 30 minutes of in-home walking while wearing the special training shoes. As an extra pre-caution, all subjects will be asked to walk with the shoes only in the presence of a caregiver, spouse or other family member during the first month. Before moving to more independent training, subjects will be checked for safety.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- APOS System - biomechanical wedge shoe
- Keywords
- Parkinson's disease, Gait Disturbances, Mobility, Quality of life
- Medical subject headings
- Parkinson Disease, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APOS System - biomechanical wedge shoeDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
gait characteristics
Measured: 3 monthes
Quality of life
Measured: 3 monthes
Mobility
Measured: 3 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2007 (estimated)
- Study startAug 2007
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson's DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Nir Giladi, MD, Principal investigator, Movement Disorders Unit - Tel Aviv Sourasky medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498758
- Sponsor's protocol ID
- tasmc-07-ng-152-ctil
- Status last verified
- Jul 2007
- First submitted
- 9 Jul 2007
- Last updated
- 10 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The APOS System: Effects on Gait, Mobility and QOL in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00498758
- Acronym / sponsor ID
- tasmc-07-ng-152-ctil
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Parkinson's disease, Gait Disturbances, Mobility, Quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Aug 2007
- Study completion
- Aug 2008 (estimated)
- First posted
- 10 Jul 2007 (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 evaluate the benefits of a biomechanical wedge system - The APOS system, for improving the stability of gait, mobility and quality of life in Parkinson's disease patients.
Detailed description
Recently, a biomechanical wedge system was developed for gait and balance training among patients suffering from gait disorders. The APOS system (APOS Medical \& Sports Technologies Ltd, Hertzeliya, Israel) applies special semispherical shoes, with individually adjusted implants, to improve age- and disease-related loss in muscle strength and neuromuscular control. The semispherical rubber devices that are placed on the soles of the shoes at the hind-foot and mid-foot can be moved medially, laterally, forwards and backwards. The system can be individually adjusted in order to optimally balance loading and re-train postural control during gait. An additional advantage of this treatment approach is the extraordinary compliance. The system is easily adjusted, maintained, and allows safe gait training.
After randomization, all subjects will be fitted with the APOS system, These shoes alter the dynamic balance during all gait cycle phases, adjusting the center of gravity and training postural control.
The precise location of the two wedges is adjusted individually by expert trainers using standardized protocols. Subjects in the intervention group will receive a proper wedge; subjects in the sham group will receive an almost flat wedge that lacks the proper biomechanical characteristics. However, both shoes and wedges will look similar. All subjects will be instructed to start gradually, with a goal of reaching 30 minutes of in-home walking while wearing the special training shoes. As an extra pre-caution, all subjects will be asked to walk with the shoes only in the presence of a caregiver, spouse or other family member during the first month. Before moving to more independent training, subjects will be checked for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Idiopathic Parkinson's disease
- Stage 2-3 Hoehn \& Yahr
Key exclusion criteria (6 listed)
- Peripheral neuropathic pain
- Dementia
- Severe orthopaedic condition
- c.v.a
- Hearing or vision loss
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 System - biomechanical wedge shoe | Device | – |
Primary outcome
gait characteristics
Time frame: 3 monthes
Quality of life
Time frame: 3 monthes
Mobility
Time frame: 3 monthes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2007.
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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.
Talia Herman contact
Yael Rotem-Galili contact
Nir Giladi, MD principal investigator
Movement Disorders Unit - Tel Aviv Sourasky medical center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APOS System - biomechanical wedge shoe in people with Idiopathic Parkinson's Disease, run by Tel-Aviv Sourasky Medical Center.
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 6 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 10 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Talia Herman (talit@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait characteristics (time frame: 3 monthes). The study lists 3 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 10 Jul 2007.