StrokePhase 1NCT01570816
Improving Ambulatory Community Access After Paralysis
A Phase 1 study testing IRS-8 (8 channel implanted receiver stimulator) in people with Stroke and Partial Paralysis, run by Louis Stokes VA Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the effectiveness of functional electrical stimulation (FES) provided by an implanted pulse generator (IPG) in correcting hip, knee and ankle function to improve walking in people with partial paralysis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Partial Paralysis, Spinal Cord Injury
- What is being tested?
- IRS-8 (8 channel implanted receiver stimulator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jul 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- problems walking because of paralysis for more than 6 months
- weak hip flexors and extensors or excessive tone
- weak ankle dorsiflexors (muscles bringing the foot up)
- weak plantar flexors (ankle muscles for push-off)
- foot drop that is causing "dragging" or "catching" toes during walking
- swinging the leg sideways or hiking the hip to clear affected leg during stepping
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- endurance to walk at least 10 ft with minimal assistance
- hip extension range to neutral
- hip flexion range greater or equal to 90 degrees
- ankle range to neutral
- sufficient upper extremity function to use a walking aid
- muscles respond to electrical stimulation
Who cannot join
- cardiac arrythmias
- demand pacemaker
- pregnancy
- Parkinson's disease
- traumatic brain injury
- autoimmune deficiency
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- uncontrolled diabetes
- significant edema of the affected limb
- active pressure ulcers or open wounds
- sepsis or an active infection
- severe osteoporosis
- uncontrolled seizures
- moderate depression
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center
Cleveland, Ohio, 44106
Lisa M Lombardo, MPT, 216-791-3800 ext. 4909, llombardo@fescenter.org
Rudi Kobetic, MSBE
About this study
The purpose of this research study is to evaluate the effectiveness of functional electrical stimulation (FES) provided by an implanted pulse generator (IPG) in correcting hip, knee and ankle function to improve walking in people with partial paralysis.
Read the detailed description
In a surgical procedure electrodes are inserted into muscles of the lower extremities to correct hip, knee and ankle function. The electrode leads are connected to an implanted pulse generator located in the abdomen. After a typical post-operative period of two to five days, the recipient will be discharged home for two to six weeks of moderate activity. Following a 6 week period of laboratory exercise and training, functional use of the neuroprosthesis will begin at home and in the community with follow-up evaluations at 1, 3, 6 and 12 months. Laboratory assessments include walking speed and distance, physiologic cost, muscle strength, measure of spasticity, and gait analysis with and without stimulation. A number of self-reporting instruments are administered to capture individual's participation, quality of life and various aspects of perceived community ambulation.
- Conditions
- Stroke, Partial Paralysis, Spinal Cord Injury, Tetraplegia, Quadriplegia
- Being tested
- IRS-8 (8 channel implanted receiver stimulator)
- Keywords
- stroke, partial paralysis, gait correction, functional electrical stimulation, paraplegia, tetraplegia, spinal cord injury
- Medical subject headings
- Stroke, Muscle Weakness, Spinal Cord Injuries, Quadriplegia, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRS-8 (8 channel implanted receiver stimulator)Device
Also called Implanted pulse generator for ambulation, Implanted FES system for lower extremities, Implated FES system for ambulation, FES system for walking
Surgical implantation of an 8 channel pulse generator to stimulate paralyzed muscles of the lower extremities
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures Receives: Device: IRS-8 (8 channel implanted receiver stimulator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of functional electrical stimulation of the hip, knee and ankle muscles to improve walking in people with partial paralysis
Experiments involving analyses of individual's speed, distance and quality of walking will be performed both with and without stimulation to determine if individuals are able to improve community ambulatory access with use of neuroprosthesis.
Measured: up to 36 months
Secondary outcomes (1)
Feasibility of initiating a step with a trigger from an accelerometer incorporated in the external control unit to adjust to environmental circumstances and situations encountered in community ambulation
Experiments involving analyses of individual's speed, distance and quality of walking will be performed both with and without accelerometer triggered stepping to determine if individuals are able to adjust to environmental circumstances and situations encountered in community ambulation.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louis Stokes VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Rudi Kobetic, Louis Stokes VA Medical Center
- Investigators
- Rudi Kobetic, MSBE, Principal investigator, Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570816
- Sponsor's protocol ID
- 12004-H02
- Other IDs
- 1I01RX000528-01A2
- Status last verified
- Mar 2018
- First submitted
- 2 Apr 2012
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bailey SN, Hardin EC, Kobetic R, Boggs LM, Pinault G, Triolo RJ. Neurotherapeutic and neuroprosthetic effects of implanted functional electrical stimulation for ambulation after incomplete spinal cord injury. J Rehabil Res Dev. 2010;47(1):7-16. doi: 10.1682/jrrd.2009.03.0034.
PubMed 20437323Hardin E, Kobetic R, Murray L, Corado-Ahmed M, Pinault G, Sakai J, Bailey SN, Ho C, Triolo RJ. Walking after incomplete spinal cord injury using an implanted FES system: a case report. J Rehabil Res Dev. 2007;44(3):333-46. doi: 10.1682/jrrd.2007.03.0333.
PubMed 18247230Triolo RJ, Bailey SN, Foglyano KM, Kobetic R, Lombardo LM, Miller ME, Pinault G. Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up. Arch Phys Med Rehabil. 2018 Feb;99(2):289-298. doi: 10.1016/j.apmr.2017.08.470. Epub 2017 Sep 9.
PubMed 28899825
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Ambulatory Community Access After Paralysis
- ClinicalTrials.gov ID
- NCT01570816
- Acronym / sponsor ID
- 12004-H02
- Conditions
- Stroke, Partial Paralysis, Spinal Cord Injury, Tetraplegia, Quadriplegia
- Keywords
- stroke, partial paralysis, gait correction, functional electrical stimulation, paraplegia, tetraplegia, spinal cord injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Louis Stokes VA Medical CenterUS federal agency
- Study start
- Apr 2012
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 4 Apr 2012 (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 research study is to evaluate the effectiveness of functional electrical stimulation (FES) provided by an implanted pulse generator (IPG) in correcting hip, knee and ankle function to improve walking in people with partial paralysis.
Detailed description
In a surgical procedure electrodes are inserted into muscles of the lower extremities to correct hip, knee and ankle function. The electrode leads are connected to an implanted pulse generator located in the abdomen. After a typical post-operative period of two to five days, the recipient will be discharged home for two to six weeks of moderate activity. Following a 6 week period of laboratory exercise and training, functional use of the neuroprosthesis will begin at home and in the community with follow-up evaluations at 1, 3, 6 and 12 months. Laboratory assessments include walking speed and distance, physiologic cost, muscle strength, measure of spasticity, and gait analysis with and without stimulation. A number of self-reporting instruments are administered to capture individual's participation, quality of life and various aspects of perceived community ambulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: IRS-8 (8 channel implanted receiver stimulator)Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- problems walking because of paralysis for more than 6 months
- weak hip flexors and extensors or excessive tone
- weak ankle dorsiflexors (muscles bringing the foot up)
- weak plantar flexors (ankle muscles for push-off)
- foot drop that is causing "dragging" or "catching" toes during walking
Key exclusion criteria (13 listed)
- cardiac arrythmias
- demand pacemaker
- pregnancy
- Parkinson's disease
- traumatic brain injury
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 |
|---|---|---|
| IRS-8 (8 channel implanted receiver stimulator)Also: Implanted pulse generator for ambulation, Implanted FES system for lower extremities, Implated FES system for ambulation, FES system for walkingSurgical implantation of an 8 channel pulse generator to stimulate paralyzed muscles of the lower extremities | Device | Experimental |
Primary outcome
The effect of functional electrical stimulation of the hip, knee and ankle muscles to improve walking in people with partial paralysis
Time frame: up to 36 months
Experiments involving analyses of individual's speed, distance and quality of walking will be performed both with and without stimulation to determine if individuals are able to improve community ambulatory access with use of neuroprosthesis.
1 secondary outcome
Feasibility of initiating a step with a trigger from an accelerometer incorporated in the external control unit to adjust to environmental circumstances and situations encountered in community ambulation
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Background: PubMed 20437323Bailey SN, Hardin EC, Kobetic R, Boggs LM, Pinault G, Triolo RJ. Neurotherapeutic and neuroprosthetic effects of implanted functional electrical stimulation for ambulation after incomplete spinal cord injury. J Rehabil Res Dev. 2010;47(1):7-16. doi: 10.1682/jrrd.2009.03.0034.
- Background: PubMed 18247230Hardin E, Kobetic R, Murray L, Corado-Ahmed M, Pinault G, Sakai J, Bailey SN, Ho C, Triolo RJ. Walking after incomplete spinal cord injury using an implanted FES system: a case report. J Rehabil Res Dev. 2007;44(3):333-46. doi: 10.1682/jrrd.2007.03.0333.
- Derived from this study: PubMed 28899825Triolo RJ, Bailey SN, Foglyano KM, Kobetic R, Lombardo LM, Miller ME, Pinault G. Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up. Arch Phys Med Rehabil. 2018 Feb;99(2):289-298. doi: 10.1016/j.apmr.2017.08.470. Epub 2017 Sep 9.
- Cleveland FES center websiteLink provided by the sponsor.
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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.
Rudi Kobetic, MSBE principal investigator
Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center
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 IRS-8 (8 channel implanted receiver stimulator) in people with Stroke and Partial Paralysis, run by Louis Stokes VA Medical Center at 1 site in United States.
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 12 inclusion and 13 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 14 Mar 2018. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa M Lombardo, MPT (216-791-3800 ext. 4909, llombardo@fescenter.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of functional electrical stimulation of the hip, knee and ankle muscles to improve walking in people with partial paralysis (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01570816, which also lists 3 linked publications.
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 14 Mar 2018.