Hysterical Simulation of DiseaseSTEPSTIMNCT01415700
Comparison Between Implanted Functional Electrical Stimulation and Foot Orthosis
A study testing Functional electrical stimulator and feet orthosis in people with Hysterical Simulation of Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve the patient's walking floor by removing the STEPPAGE, reducing the effort of walking, facilitating the flow and removing anomalies… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hysterical Simulation of Disease
- What is being tested?
- Functional electrical stimulator and feet orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Jan 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEPPAGE foot walking in a patient with a central neurological disease
- can walk for 50 meters with or without technical assistance
- stable disease for at least 1 year
- possible walk with a brace-type reliever
- verification of possible nerve stimulation
- age greater than or equal to 18 years and under 75 years
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- no toxin for 4 months
- no alcohol for 6 months
- no neurotomy for 1 year
- patient who agreed to sign an informed consent to participate in the study
Who cannot join
- cons-indication to general anesthesia
- wearing a stimulator implanted for other reasons
- patients taking neuroleptics, benzodiazepines, or antidepressants or other drugs that interfere with the quality of walking
- advanced peripheral neuropathy
- excessive restriction of passive range of ankle
- poorly controlled epilepsy
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- pregnant or lactating
- non-membership of a social security scheme
- wearing orthopaedic shoes including the malleolus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implanted Functional Electrical Stimulation of the Levators of the Ankle Versus Orthosis in the Treatment of Chronic Foot Neurological STEPPAGE-gait by Central Attack
The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve the patient's walking floor by removing the STEPPAGE, reducing the effort of walking, facilitating the flow and removing anomalies compensatory (such as the mowing of the hip). Its objective is to improve the patient's autonomy locomotor.
The aim of this study is to compare the results of the implementation of an implanted stimulator in the levator muscles of the foot to the results obtained by wearing a splint-type reliever, which is considered standard treatment, in order to determine if the implanted stimulation may be proposed in the treatment of foot drop off a neurological center.
Read the detailed description
The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve the patient's walking floor by removing the STEPPAGE, reducing the effort of walking, facilitating the flow and removing anomalies compensatory (such as the mowing of the hip). Its objective is to improve the patient's autonomy locomotor.
- Conditions
- Hysterical Simulation of Disease
- Being tested
- Functional electrical stimulator, feet orthosis
- Keywords
- feet STEPPAGE of central neurological origin, implanted functional electrical stimulation, feet orthosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional electrical stimulatorDevice
The stimulator is surgically implanted
feet orthosisDevice
feet orthosis specifically mold
| Study group | Role | What they receive |
|---|---|---|
| Stimulator | Experimental | Not described Receives: Device: Functional electrical stimulator |
| Orthosis | Active comparator | Not described Receives: Device: feet orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of walking speed at 3 months
The measurement is taken for a spontaneous march floor then fast. It follows from the establishment of the average of 3 to 5 passes on a walking track of a platform for analysis of movement
Measured: Measurement will be performed at 3 months
Measurement of walking speed at 6 months
The measurement is taken for a spontaneous march floor then fast. It follows from the establishment of the average of 3 to 5 passes on a walking track of a platform for analysis of movement
Measured: Measurement will be performed at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hysterical Simulation of DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Decq, PUPH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415700
- Sponsor's protocol ID
- P070155
- Other IDs
- 2007-A01444-49
- Acronym
- STEPSTIM
- Status last verified
- Jul 2014
- First submitted
- 8 Aug 2011
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implanted Functional Electrical Stimulation of the Levators of the Ankle Versus Orthosis in the Treatment of Chronic Foot Neurological STEPPAGE-gait by Central Attack
- ClinicalTrials.gov ID
- NCT01415700
- Acronym / sponsor ID
- STEPSTIM / P070155
- Conditions
- Hysterical Simulation of Disease
- Keywords
- feet STEPPAGE of central neurological origin, implanted functional electrical stimulation, feet orthosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 12 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.
The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve the patient's walking floor by removing the STEPPAGE, reducing the effort of walking, facilitating the flow and removing anomalies compensatory (such as the mowing of the hip). Its objective is to improve the patient's autonomy locomotor.
The aim of this study is to compare the results of the implementation of an implanted stimulator in the levator muscles of the foot to the results obtained by wearing a splint-type reliever, which is considered standard treatment, in order to determine if the implanted stimulation may be proposed in the treatment of foot drop off a neurological center.
Detailed description
The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve the patient's walking floor by removing the STEPPAGE, reducing the effort of walking, facilitating the flow and removing anomalies compensatory (such as the mowing of the hip). Its objective is to improve the patient's autonomy locomotor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulator | Experimental | Device: Functional electrical stimulator |
| Orthosis | Active comparator | Device: feet orthosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- STEPPAGE foot walking in a patient with a central neurological disease
- can walk for 50 meters with or without technical assistance
- stable disease for at least 1 year
- possible walk with a brace-type reliever
- verification of possible nerve stimulation
Key exclusion criteria (9 listed)
- cons-indication to general anesthesia
- wearing a stimulator implanted for other reasons
- patients taking neuroleptics, benzodiazepines, or antidepressants or other drugs that interfere with the quality of walking
- advanced peripheral neuropathy
- excessive restriction of passive range of ankle
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 |
|---|---|---|
| Functional electrical stimulatorThe stimulator is surgically implanted | Device | Stimulator |
| feet orthosisfeet orthosis specifically mold | Device | Orthosis |
Primary outcome
Measurement of walking speed at 3 months
Time frame: Measurement will be performed at 3 months
The measurement is taken for a spontaneous march floor then fast. It follows from the establishment of the average of 3 to 5 passes on a walking track of a platform for analysis of movement
Measurement of walking speed at 6 months
Time frame: Measurement will be performed at 6 months
The measurement is taken for a spontaneous march floor then fast. It follows from the establishment of the average of 3 to 5 passes on a walking track of a platform for analysis of movement
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 28 Jul 2014.
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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.
Philippe Decq, PUPH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional electrical stimulator and feet orthosis in people with Hysterical Simulation of Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 10 inclusion and 9 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 28 Jul 2014. 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 France. 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?
Measurement of walking speed at 3 months (time frame: Measurement will be performed at 3 months). The study lists 2 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 28 Jul 2014.