StrokeNCT01116466
Clinical Study to Evaluate the Implantation of the ActiGait Drop Foot Stimulator System
A study testing ActiGait in people with Stroke and Hemiplegia, run by Otto Bock Healthcare Products GmbH.
Trial summary
The objective of this study is to evaluate the efficacy and safety of surgical procedure involving ActiGait - implantable drop foot stimulator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- ActiGait
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- have a single sided hemiparesis persisting for more than 6 months due to a cerebro-vascular accident (CVA).
- be fully grown-up.
- have the ability to walk 20 meters in less than 2 minutes with or without walking aid but without the help of another person.
- have a reduced speed of walking.
- have the ability to stand upright with both heels touching the floor while hip and knee are in neutral position.
- have a passive range of movement of the affected ankle joint of at least 30 degrees.
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- have a positive response to surface electrical stimulation of the peroneal nerve - i.e. muscle contraction which results in dorsiflexion of the ankle and improved gait.
- male or female older than 18 years of age.
- have signed written Informed consent to participate in the study.
- is willing and able to follow all study procedures including attendance at clinics for scheduled study visits.
Who cannot join
- peripheral nerve damage of the affected leg.
- severe or uncontrolled diabetes with peripheral nerve involvement.
- poor skin condition on the affected leg.
- a thickness of subcutaneous fat exceeding 3.5 cm in the region of the implant.
- inability to walk 100 meters without stopping prior to CVA (with or without a walking aid, but without the help of another person).
- poorly controlled epilepsy.
Show all 23Show fewer
- need of Ankle Foot Orthosis (AOF) to maintain ankle stability.
- concomitant medical and psychological conditions which would limit the success of the ActiGait® system such as: active degenerative diseases of the back and lower limbs, visuo-spatial neglect, or drug abuse, personality disorders or poor cognitive function.
- concomitant medical and psychological conditions which would compromise the safety of the patient in connection with the implantation and use of the ActiGait system, such as: severe cardiac disease, uncontrolled hypertension or history of malignancy within the preceding five years.
- other active implanted devices such as demand pacemakers or implanted defibrillators, as mutual electromagnetic interference may distort the efficacy of both systems and expose the patient to dangerous situations.
- history of falls greater than once a week.
- pregnancy and lactation. Women of childbearing potential must maintain effective contraception during the study period, as judged by the investigator.
- previous participation in this study
- participation in an investigational drug trial within 4 weeks prior to enrolment.
- requirement of an interpreter
- use of external FES system to assist walking four weeks prior to enrolment
- MRI of the affected thigh that is inconsistent with safe implantation of the ActiGait
- history of falls greater than once a week.
- pregnancy and lactation. Women of childbearing potential must maintain effective contraception during the study period, as judged by the investigator.
- previous participation in this study.
- participation in an investigational drug trial within 4 weeks prior to enrolment.
- requirement of an interpreter.
- anatomic situation of the common peroneal nerve identified by pre-surgical MRI that could compromise the success of ActiGait).
About this study
The objective of this study is to evaluate the efficacy and safety of surgical procedure involving ActiGait - implantable drop foot stimulator.
Read the detailed description
Stroke is the third leading cause of death in the United States and other developed countries and a major source of disability. Prognosis for regaining the ability to walk is good, with 64% of those initially dependent in walking regaining independence by 3 months. However, many gait abnormalities persist. A conservative estimate suggests that 20% of stroke survivors have a drop foot. Drop foot following stroke is caused by paresis of the ankle dorsiflexor muscles. It prevents the patient from effectively swinging the leg during walking, causing an abnormal gait characterized by hip hitching and circumduction and toe catch. Walking speed in people with drop foot is often significantly reduced and the risk of stumbling or falling is high. The conventional treatment for drop foot is an ankle-foot orthosis (AFO). While AFOs are appropriate for many patients, in certain patient groups AFOs have significant limitations (e.g. in patients with strong spasticity, suffering from pronounced inversion, suffering from volume changes in the lower extremity, etc). An alternative way of treating drop foot is by means of functional electrical stimulation. Clinical studies evaluating the effectiveness of drop foot stimulation suggest that it provides many benefits to patients, such as an improved confidence in walking, increased walking speed and endurance, less effort during walking and reduced spasticity. Implantable systems such as ActiGait are considered therapeutic alternatives specifically for those patients for whom conventional treatments have failed. ActiGait system consists of an external module (antenna and control module), a foot switch transmitting to the external module and an implanted assembly (receiver, pulse train generator, electrodes). The objective of this study is to obtain additional evidence on safety of ActiGait implantation procedure and on its efficacy. The study will enrol 5 subjects that will be implanted and followed for 12 weeks. Efficacy outcomes will be assessed at the baseline and during two follow-up visits (week 6 and 12). Subjects will be asked to walk with and without their preferred walking at the baseline and with and without stimulation at follow-up visits.
- Conditions
- Stroke, Hemiplegia
- Being tested
- ActiGait
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiGaitDevice
ActiGait - implantable drop foot stimulator
| Study group | Role | What they receive |
|---|---|---|
| ActiGait | Experimental | Receiving ActiGait - implantable drop foot stimulator Receives: Device: ActiGait |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Walked in 6 Minutes
The test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity (endurance). At baseline this test was done with subject's conventional walking aid. At 6 and 12 weeks post-implantation this was done with and without stimulation.
Measured: Baseline, 6 and 12 weeks post-implantation
Secondary outcomes (5)
Walking Speed During 10 Meter Gait Test
The test assesses walking speed in meters per second over a short duration. At baseline this test was done with subject's conventional walking aid. At 6 and 12 weeks post-implantation this was done with and without stimulation.
Measured: Baseline, 6 and 12 weeks post-implantation
Canadian Occupational Performance Measure (COPM) Score
A semi-structured interview is conducted in order to identify subject's limitations with daily occupations of importance in categories self-care, productivtiy or leisure. The subject is then asked to rate the imporance of each of the occupations using a 10-point rating scale. Afterwards the subject chooses up to 5 of the most important occupations (problems) (basis for identifying intervention goals). The subject is asked to use a 10 point scale to rate level of performance and satisfaction with performance for each of the five identified problems. Average COPM performance score and satisfaction score are calculated. The scores range between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction.
Measured: Baseline,12 weeks post-implantation
Four Square Step Test (FSST)
It is a test of dynamic balance that clinically assesses the person's ability to step over objects forward, sideways, and backwards. The patient's time to perform the test is measured which shorter time representing better performance. At baseline this test was done with subject's conventional walking aid. At 12 weeks post-implantation it was done with and without stimulation.
Measured: Baseline, week 12 post-implantation
Nerve Conduction Velocity of the Peroneal Nerve
Measured: Nervus peroneus communis (CPN) and Nervus peroneus superficialis (SPN)
Measured: Baseline, week 12 post-implantation
Change in MRI of Affected Leg and Implant Post-implantation
MRI will be conducted to evaluate the impact of the implant on the common peroneal nerve (e.g. positioning of the nerve cuff along the nerve, path of the lead wire and the common peroneal nerve, estimation of the cross-sectional area of the common peroneal nerve compared to the pre-operative MRI recording, etc.).
The outcome will be quantified by surgeon's judgement whether the final implant position is consistent with safe application of the ActiGait® implant as described in the manufacturer's surgical manual. Number of safe and successful implantations will be counted.
Measured: Week 2 post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startAug 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otto Bock Healthcare Products GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Liebetanz, MD, Principal investigator, Medical University Georg-August-University Goettingen, GermanyVeit Rhode, MD, Principal investigator, Medical University Georg-August-University Goettingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116466
- Sponsor's protocol ID
- PB-SA844-100
- Status last verified
- Jun 2021
- First submitted
- 23 Apr 2010
- Last updated
- 26 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Implantation of the ActiGait Drop Foot Stimulator System
- ClinicalTrials.gov ID
- NCT01116466
- Acronym / sponsor ID
- PB-SA844-100
- Conditions
- Stroke, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Otto Bock Healthcare Products GmbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Posted 17 Nov 2014
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 study is to evaluate the efficacy and safety of surgical procedure involving ActiGait - implantable drop foot stimulator.
Detailed description
Stroke is the third leading cause of death in the United States and other developed countries and a major source of disability. Prognosis for regaining the ability to walk is good, with 64% of those initially dependent in walking regaining independence by 3 months. However, many gait abnormalities persist. A conservative estimate suggests that 20% of stroke survivors have a drop foot. Drop foot following stroke is caused by paresis of the ankle dorsiflexor muscles. It prevents the patient from effectively swinging the leg during walking, causing an abnormal gait characterized by hip hitching and circumduction and toe catch. Walking speed in people with drop foot is often significantly reduced and the risk of stumbling or falling is high. The conventional treatment for drop foot is an ankle-foot orthosis (AFO). While AFOs are appropriate for many patients, in certain patient groups AFOs have significant limitations (e.g. in patients with strong spasticity, suffering from pronounced inversion, suffering from volume changes in the lower extremity, etc). An alternative way of treating drop foot is by means of functional electrical stimulation. Clinical studies evaluating the effectiveness of drop foot stimulation suggest that it provides many benefits to patients, such as an improved confidence in walking, increased walking speed and endurance, less effort during walking and reduced spasticity. Implantable systems such as ActiGait are considered therapeutic alternatives specifically for those patients for whom conventional treatments have failed. ActiGait system consists of an external module (antenna and control module), a foot switch transmitting to the external module and an implanted assembly (receiver, pulse train generator, electrodes). The objective of this study is to obtain additional evidence on safety of ActiGait implantation procedure and on its efficacy. The study will enrol 5 subjects that will be implanted and followed for 12 weeks. Efficacy outcomes will be assessed at the baseline and during two follow-up visits (week 6 and 12). Subjects will be asked to walk with and without their preferred walking at the baseline and with and without stimulation at follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ActiGait | Experimental | Device: ActiGaitReceiving ActiGait - implantable drop foot stimulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- have a single sided hemiparesis persisting for more than 6 months due to a cerebro-vascular accident (CVA).
- be fully grown-up.
- have the ability to walk 20 meters in less than 2 minutes with or without walking aid but without the help of another person.
- have a reduced speed of walking.
- have the ability to stand upright with both heels touching the floor while hip and knee are in neutral position.
Key exclusion criteria (23 listed)
- peripheral nerve damage of the affected leg.
- severe or uncontrolled diabetes with peripheral nerve involvement.
- poor skin condition on the affected leg.
- a thickness of subcutaneous fat exceeding 3.5 cm in the region of the implant.
- inability to walk 100 meters without stopping prior to CVA (with or without a walking aid, but without the help of another person).
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 |
|---|---|---|
| ActiGaitActiGait - implantable drop foot stimulator | Device | ActiGait |
Primary outcome
Distance Walked in 6 Minutes
Time frame: Baseline, 6 and 12 weeks post-implantation
The test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity (endurance). At baseline this test was done with subject's conventional walking aid. At 6 and 12 weeks post-implantation this was done with and without stimulation.
5 secondary outcomes
Walking Speed During 10 Meter Gait Test
Time frame: Baseline, 6 and 12 weeks post-implantation
Canadian Occupational Performance Measure (COPM) Score
Time frame: Baseline,12 weeks post-implantation
Four Square Step Test (FSST)
Time frame: Baseline, week 12 post-implantation
Nerve Conduction Velocity of the Peroneal Nerve
Time frame: Baseline, week 12 post-implantation
Change in MRI of Affected Leg and Implant Post-implantation
Time frame: Week 2 post-implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Liebetanz, MD principal investigator
Medical University Georg-August-University Goettingen, Germany
Veit Rhode, MD principal investigator
Medical University Georg-August-University Goettingen, Germany
Questions about this trial
What is this clinical trial studying?
A study testing ActiGait in people with Stroke and Hemiplegia, run by Otto Bock Healthcare Products GmbH.
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 23 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 26 Aug 2021. 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?
Yes. Results are posted in the registry (first posted 17 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Distance Walked in 6 Minutes (time frame: Baseline, 6 and 12 weeks post-implantation). 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 26 Aug 2021.