Gait, HemiplegicNCT03447717
Implanted Drop Foot Stimulator for Hemiparetic Patients
A study testing ActiGait in people with Gait, Hemiplegic, run by Medical University of Vienna.
Trial summary
The aim of this study is to investigate the effects of the implantable drop foot stimulator "ActiGait" (Ottobock Health Care, Duderstadt, Germany) on gait in hemiparetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gait, Hemiplegic
- What is being tested?
- ActiGait
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 26 Jul 2012to 29 Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- drop foot after stroke, brain haemorrhage or multiple sclerosis
- a minimum of six months after the acute infarction/onset of the disease
- passive extension of the ankle to at least at neutral position
- no sufficient active ankle extension
- free walking without any aid for at least 20 meters in less than 2 minutes
- a walking speed of ≤ 1,2m/sec (measured with 10 meter walking test)
- use of surface electrical stimulation for at least three months
- be able to stand freely
Who cannot join
- damage to the peripheral nervous system
- epilepsy
- adiposity
- substance abuse
- no cognitive ability to follow the study instructions
- pregnancy
- use of other implanted devices
- instable ankle joint or fixed contracture
About this study
Official title: The Long-term Effects of an Implantable Drop Foot Stimulator on Gait in Hemiparetic Patients
The aim of this study is to investigate the effects of the implantable drop foot stimulator "ActiGait" (Ottobock Health Care, Duderstadt, Germany) on gait in hemiparetic patients. While several studies investigated the effects of implanted systems on walking speed and gait endurance, only a few studies have focused on the system's impact on kinematics and long-term outcomes. Therefore, our aim was to further investigate the effects of the implanted system ActiGait on gait kinematics and spatiotemporal parameters with a 1-year follow-up period.
Read the detailed description
Patients with a neurologic condition leading to drop foot during swing phase in gait are treated by the implentation of the AcitGait system (which has a CE-certificate in Europe).
The aim of this study is to investigate the effect of the device on gait with a follow-up period of one year. Patients are assessed before implantation and at one-year follow up. At baseline, they are asked to walk without any assistive device, as well as with surface electrical stimulation of the peroneal nerve. At follow-up, they are asked to walk with the ActiGait system switched off and switched on.
Outcome assessments include a 10m-walking test and gait analysis with a VICON 3D-camera system. This allows to extract spatio-temporal parameters (as steps per minute, step length,...) as well as kinematic data (e.g. joint ankles during the gait cycle). All outcome data is analyzed using statistical tests.
- Conditions
- Gait, Hemiplegic
- Being tested
- ActiGait
- Keywords
- hemiplegic gait, peroneal nerve stimulation, gait analysis
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiGaitDevice
implanted device for peroneal nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| ActiGait | Experimental | Patients who get the ActiGait implant Receives: Device: ActiGait |
What is being measured
The primary outcome is the main question the study is designed to answer.
kinematic gait parameters
Kinematic gait parameters are recorded and analysed using a 3D VICON infra-red camera system.
Measured: 1 year
Secondary outcomes (3)
spatio-temporal parameters
Spatio-temproal parameters are recorded and analysed using a 3D VICON infra-red camera system.
Measured: 1 year
10-m-walking test
The 10-m-walking test is a standardised clinical test where the patient is asked to walk for 10m at the fastest convenient walking speed and time is taken.
Measured: 1 year
Visual Analogue Scale for Health
Using a 100mm Visual Analogue Scale (VAS) patients are asked to mark their current health status between 0 (worst possible health) and 100 (best possible health).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start26 Jul 2012
- Primary completion29 Feb 2016
- Study completion29 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait, HemiplegicStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- patients meeting the inclusion criteria are included
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Sturma, Medical University of Vienna
- Investigators
- Oskar C Aszmann, MD, Study director, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447717
- Sponsor's protocol ID
- 2126/2016
- Status last verified
- Feb 2018
- First submitted
- 21 Feb 2018
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD from the mentioned outcome parameters are planned to be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Effects of an Implantable Drop Foot Stimulator on Gait in Hemiparetic Patients
- ClinicalTrials.gov ID
- NCT03447717
- Acronym / sponsor ID
- 2126/2016
- Conditions
- Gait, Hemiplegic
- Keywords
- hemiplegic gait, peroneal nerve stimulation, gait analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 26 Jul 2012 (actual)
- Primary completion
- 29 Feb 2016 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 27 Feb 2018 (actual)
- 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 aim of this study is to investigate the effects of the implantable drop foot stimulator "ActiGait" (Ottobock Health Care, Duderstadt, Germany) on gait in hemiparetic patients. While several studies investigated the effects of implanted systems on walking speed and gait endurance, only a few studies have focused on the system's impact on kinematics and long-term outcomes. Therefore, our aim was to further investigate the effects of the implanted system ActiGait on gait kinematics and spatiotemporal parameters with a 1-year follow-up period.
Detailed description
Patients with a neurologic condition leading to drop foot during swing phase in gait are treated by the implentation of the AcitGait system (which has a CE-certificate in Europe).
The aim of this study is to investigate the effect of the device on gait with a follow-up period of one year. Patients are assessed before implantation and at one-year follow up. At baseline, they are asked to walk without any assistive device, as well as with surface electrical stimulation of the peroneal nerve. At follow-up, they are asked to walk with the ActiGait system switched off and switched on.
Outcome assessments include a 10m-walking test and gait analysis with a VICON 3D-camera system. This allows to extract spatio-temporal parameters (as steps per minute, step length,...) as well as kinematic data (e.g. joint ankles during the gait cycle). All outcome data is analyzed using statistical tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients meeting the inclusion criteria are included
| Arm | Type | Receives |
|---|---|---|
| ActiGait | Experimental | Device: ActiGaitPatients who get the ActiGait implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- drop foot after stroke, brain haemorrhage or multiple sclerosis
- a minimum of six months after the acute infarction/onset of the disease
- passive extension of the ankle to at least at neutral position
- no sufficient active ankle extension
- free walking without any aid for at least 20 meters in less than 2 minutes
Key exclusion criteria (8 listed)
- damage to the peripheral nervous system
- epilepsy
- adiposity
- substance abuse
- no cognitive ability to follow the study instructions
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 |
|---|---|---|
| ActiGaitimplanted device for peroneal nerve stimulation | Device | ActiGait |
Primary outcome
kinematic gait parameters
Time frame: 1 year
Kinematic gait parameters are recorded and analysed using a 3D VICON infra-red camera system.
3 secondary outcomes
spatio-temporal parameters
Time frame: 1 year
10-m-walking test
Time frame: 1 year
Visual Analogue Scale for Health
Time frame: 1 year
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 27 Feb 2018.
- Individual participant dataSharing planned: Yes. All IPD from the mentioned outcome parameters are planned to be made available to other researchers.
Related trials for Gait, Hemiplegic
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Active, not recruitingObservational study
Focused Intensive Repeated Stepping During Inpatient Rehabilitation Poststroke - A Quality Improvement Project
Stroke, Acute, Gait, Hemiplegic
Active, not recruiting
Virtual Reality Vs Postural Control Training in Children With Cerebral Palsy
Children With Hemiplegic cp
Active, not recruiting
Implant for Walking After Stroke
Stroke, Hemiplegia
Enrolling by invitation
Clinical Validation of Self-Pacing Algorithms on Step Length Symmetry in Hemiplegic Populations
Stroke, Traumatic Brain Injury
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.
Oskar C Aszmann, MD study director
Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
A study testing ActiGait in people with Gait, Hemiplegic, run by Medical University of Vienna.
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 8 inclusion and 8 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 27 Feb 2018. 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.
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?
kinematic gait parameters (time frame: 1 year). 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 2018.