Weight-bearing DeficitsPhase 1NCT01127685
Weight-bearing Measuring Device Following Anterior Cruciate Ligament Reconstruction
A Phase 1 study testing Smart_Step weight bearing insole in people with Weight-bearing Deficits, run by Meir Medical Center at 1 site in Israel.
Trial summary
The objective of this clinical trial is to in determining weight-bearing deficits following anterior cruciate ligament reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight-bearing Deficits
- What is being tested?
- Smart_Step weight bearing insole
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- May 2010to Jul 2011
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients more than 18 years old, derivate to physiotherapy treatment in Lerner Central Sport, Hebrew University - Jerusalem
- Patients who are willing to participate in the trial and to sign the informed consent forms.
Who cannot join
- Patients receiving other methods of treatment to this area,
- Patients with concomitant other injury of the hip, knee, ankle or foot.
- Non cooperative patient.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Jerusalem Sports Medicine Institute, Lerner Sports Center, Hebrew University of Jerusalem.
Jerusalem
About this study
Official title: The Use of a Biofeedback Insole Weight-bearing Measuring Device in Determining Weight-bearing Deficits Following Anterior Cruciate Ligament Reconstruction
The objective of this clinical trial is to in determining weight-bearing deficits following anterior cruciate ligament reconstruction.
Read the detailed description
Orthopedic surgeons and rehabilitation physicians frequently request limited weight-bearing for prolonged periods following certain bony or soft tissue pathologies as well as certain lower - limb surgical procedures. Walking, stair climbing, jogging, elliptical training and running on treadmill are a common activity that the injured athlete will seek to return to as soon as possible following injury or surgery. In order for the physician to be able to advise regarding weight-bearing, the Percentage Body-Weight/Weight-Bearing (PBW/WB) values in increasing walking, jogging speeds, elliptical training must be known. These parameters as well as the gait distribution changes have eluded the rehabilitation community, mainly due to the technical inability to measure these paradigms.
There are no short-term studies quantifying weight-bearing deficits as well as weight-bearing gait distribution characteristics following Anterior Cruciate Ligament Reconstruction (ACLR). Furthermore, there are no published studies that have investigated whether differences exist between various surgical procedures and replacement graft choices in the acute- phase (0-3 weeks) post surgery
Descriptive clinical trial. During their regular training the participants will use the flexible, light weight, force-sensing insole for few minutes to receive the parameters 30 subjects. The test subjects will be instructed to walk at their normal speed on a solid ground surface over a distance of 16 meters.
The results will be analyzed and a table of normal values will be established including average PBW/WB values for the entire, hind and fore-foot as well as gait distribution changes.
- Conditions
- Weight-bearing Deficits
- Being tested
- Smart_Step weight bearing insole
- Keywords
- weight bearing, acl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart_Step weight bearing insoleDevice
Also called weight bearing biofeedback insole device
The use of a weight-bearing measuring device in determining weight-bearing deficits following Anterior Cruciate Ligament Reconstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
The Use of a Biofeedback Insole Weight-bearing Measuring Device in Determining Weight-bearing Deficits Following Anterior Cruciate Ligament Reconstruction
Descriptive clinical trial. During their regular training the participants will use the flexible, light weight, force-sensing insole for few minutes to receive the parameters 30 subjects. The test subjects will be instructed to walk at their normal speed on a solid ground surface over a distance of 16 meters.
The results will be analyzed and a table of normal values will be established including average PBW/WB values for the entire, hind and fore-foot as well as gait distribution changes
Measured: During their regular training the participants will use the flexible, light weight, force-sensing insole for few minutes to receive the parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight-bearing DeficitsStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127685
- Sponsor's protocol ID
- MMC10043-2010CTIL
- Status last verified
- Aug 2011
- First submitted
- 27 Apr 2010
- Last updated
- 30 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Biofeedback Insole Weight-bearing Measuring Device in Determining Weight-bearing Deficits Following Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT01127685
- Acronym / sponsor ID
- MMC10043-2010CTIL
- Conditions
- Weight-bearing Deficits
- Keywords
- weight bearing, acl
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 May 2010 (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 objective of this clinical trial is to in determining weight-bearing deficits following anterior cruciate ligament reconstruction.
Detailed description
Orthopedic surgeons and rehabilitation physicians frequently request limited weight-bearing for prolonged periods following certain bony or soft tissue pathologies as well as certain lower - limb surgical procedures. Walking, stair climbing, jogging, elliptical training and running on treadmill are a common activity that the injured athlete will seek to return to as soon as possible following injury or surgery. In order for the physician to be able to advise regarding weight-bearing, the Percentage Body-Weight/Weight-Bearing (PBW/WB) values in increasing walking, jogging speeds, elliptical training must be known. These parameters as well as the gait distribution changes have eluded the rehabilitation community, mainly due to the technical inability to measure these paradigms.
There are no short-term studies quantifying weight-bearing deficits as well as weight-bearing gait distribution characteristics following Anterior Cruciate Ligament Reconstruction (ACLR). Furthermore, there are no published studies that have investigated whether differences exist between various surgical procedures and replacement graft choices in the acute- phase (0-3 weeks) post surgery
Descriptive clinical trial. During their regular training the participants will use the flexible, light weight, force-sensing insole for few minutes to receive the parameters 30 subjects. The test subjects will be instructed to walk at their normal speed on a solid ground surface over a distance of 16 meters.
The results will be analyzed and a table of normal values will be established including average PBW/WB values for the entire, hind and fore-foot as well as gait distribution changes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female patients more than 18 years old, derivate to physiotherapy treatment in Lerner Central Sport, Hebrew University - Jerusalem
- Patients who are willing to participate in the trial and to sign the informed consent forms.
Key exclusion criteria (3 listed)
- Patients receiving other methods of treatment to this area,
- Patients with concomitant other injury of the hip, knee, ankle or foot.
- Non cooperative patient.
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 |
|---|---|---|
| Smart_Step weight bearing insoleAlso: weight bearing biofeedback insole deviceThe use of a weight-bearing measuring device in determining weight-bearing deficits following Anterior Cruciate Ligament Reconstruction | Device | – |
Primary outcome
The Use of a Biofeedback Insole Weight-bearing Measuring Device in Determining Weight-bearing Deficits Following Anterior Cruciate Ligament Reconstruction
Time frame: During their regular training the participants will use the flexible, light weight, force-sensing insole for few minutes to receive the parameters
Descriptive clinical trial. During their regular training the participants will use the flexible, light weight, force-sensing insole for few minutes to receive the parameters 30 subjects. The test subjects will be instructed to walk at their normal speed on a solid ground surface over a distance of 16 meters. The results will be analyzed and a table of normal values will be established including average PBW/WB values for the entire, hind and fore-foot as well as gait distribution changes
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 30 Aug 2011.
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 Phase 1 study testing Smart_Step weight bearing insole in people with Weight-bearing Deficits, run by Meir 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 3 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 30 Aug 2011. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The Use of a Biofeedback Insole Weight-bearing Measuring Device in Determining Weight-bearing Deficits Following Anterior Cruciate Ligament Reconstruction (time frame: During their regular training the participants will use the flexible, light weight, force-sensing insole for few minutes to receive the parameters). 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 30 Aug 2011.