Ankle InjuriesNCT00268658
Clinical Use of Andante SmartStep System in Gait Rehabilitation
A study testing SmartStep(tm) biofeedback device in people with Ankle Injuries and Femoral Neck Fractures, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the effectiveness of the biofeedback gait training device in improving load bearing over an operated limb, during post-operative gait training therapy. The effectiveness of the device will also be tested in self-training at home. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ankle Injuries, Femoral Neck Fractures
- What is being tested?
- SmartStep(tm) biofeedback device
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rehabilitation after operation
- Patient is allowed full weight bearing
- Patient is motivated and able to communicate and understands orders
- Patient is able to walk 10 meters
- Patient filled out agreement and consent form
Who cannot join
- Activity limitation due to medical disorder, medications, or emotional status.
- Pain markedly obstructs gait ability
- Documented peripheral neuropathy
- Functional limitation prior to the current condition
- Premorbid, ongoing major depression or psychosis
- Multiple/pathological fractures
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- Serious early complications
- Terminally ill patients
- Pregnant women
- Participation in current or recent (within 60 days prior to surgery) clinical trial
Trial locations and contacts
1 site in 1 country.
Israel1 site
Soroka University Medical Center
Beersheba, 00000
Daniel Plotkin, MD, 972-507-633433, ctrials@gmail.com
About this study
The purpose of this study is to evaluate the effectiveness of the biofeedback gait training device in improving load bearing over an operated limb, during post-operative gait training therapy. The effectiveness of the device will also be tested in self-training at home.
Read the detailed description
To evaluate the effectiveness of the biofeedback gait training device as a biofeedback training therapeutic tool in improving body-weight bearing over the affected lower limb, quality of gait, level of ambulation and physical independence during rehabilitation, in patients after orthopedic procedures during gait therapy training, and as a biofeedback device for self-training at home.
- Conditions
- Ankle Injuries, Femoral Neck Fractures
- Being tested
- SmartStep(tm) biofeedback device
- Keywords
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Arthroscopy
- Medical subject headings
- Ankle Injuries, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartStep(tm) biofeedback deviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
load bearing over the affected lower limb
quality/symmetry of gait
level of ambulation and physical independence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Daniel Plotkin, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268658
- Sponsor's protocol ID
- sor412805ctil
- Status last verified
- Nov 2005
- First submitted
- 21 Dec 2005
- Last updated
- 27 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Use of Andante SmartStep System in Gait Rehabilitation
- ClinicalTrials.gov ID
- NCT00268658
- Acronym / sponsor ID
- sor412805ctil
- Conditions
- Ankle Injuries, Femoral Neck Fractures
- Keywords
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Arthroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- First posted
- 22 Dec 2005 (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 effectiveness of the biofeedback gait training device in improving load bearing over an operated limb, during post-operative gait training therapy. The effectiveness of the device will also be tested in self-training at home.
Detailed description
To evaluate the effectiveness of the biofeedback gait training device as a biofeedback training therapeutic tool in improving body-weight bearing over the affected lower limb, quality of gait, level of ambulation and physical independence during rehabilitation, in patients after orthopedic procedures during gait therapy training, and as a biofeedback device for self-training at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Rehabilitation after operation
- Patient is allowed full weight bearing
- Patient is motivated and able to communicate and understands orders
- Patient is able to walk 10 meters
- Patient filled out agreement and consent form
Key exclusion criteria (10 listed)
- Activity limitation due to medical disorder, medications, or emotional status.
- Pain markedly obstructs gait ability
- Documented peripheral neuropathy
- Functional limitation prior to the current condition
- Premorbid, ongoing major depression or psychosis
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 |
|---|---|---|
| SmartStep(tm) biofeedback device | Device | – |
Primary outcome
load bearing over the affected lower limb
quality/symmetry of gait
level of ambulation and physical independence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 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.
Daniel Plotkin, MD principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartStep(tm) biofeedback device in people with Ankle Injuries and Femoral Neck Fractures, run by Soroka University 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 5 inclusion and 10 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 27 Feb 2007. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
load bearing over the affected lower limb. 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 27 Feb 2007.