StrokeNCT00864708
Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008
A study of Stroke, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of the study is to investigate new Technology for recovery of ankle walking function after stroke. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Apr 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sufficient endurance to participate in rehabilitation sessions.
- Medically Stable
- Age >21 years.
- Inability to perform normal ankle coordinated gait components.
- Participants should be able to walk and keep balance without physical assistance from another person
Who cannot join
- Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy.
- Lower motor neuron damage or radiculopathy
- Allergy or contraindication to anesthesia, Versed, (or comparable substitute.
- Active implantable device (e.g. pacemaker, implantable cardiac defibrillator, neurostimulator, or drug infusion device.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to investigate new Technology for recovery of ankle walking function after stroke.
Read the detailed description
Background and Purpose: Conventional rehabilitation does not restore normal, upper limb function or normal gait to many stroke survivors. Functional neuromuscular stimulation (FNS) has shown promise for functional enhancement of both upper and lower limb motor control following stroke. Gains included muscle activation latencies, strength, coordination, upper limb functional tasks, gait kinematics, walking endurance, and quality of life. The purpose of the proposed work is to test the radio frequency-controlled (RF) Microstimulator (RFM) Gait System regarding system performance and subject response to treatment.
Methods: This is a feasibility study in which up to four subjects will receive the (RFM) Gait System. Up to ten RFMs will be placed for a given subject. An RFM ankle muscle system will be used to train ankle gait components. A separate RFM system will be used to train knee gait components. Subjects will be treated for 6 months, four sessions/wk. Primary outcome measures for the RFM Gait System will be: kinematic swing phase gait components and walking endurance. Secondary outcome measures will include: strength, coordination, spasticity, function, and quality of life. Data collections will occur at months 1, 3 and 6, and for follow-up times up to a year after the end of treatment. The results of the RFM ankle system have the potential to provide a new technology for ankle muscle gait components.
- Conditions
- Stroke
- Being tested
- radio frequency-controlled (RF) Microstimulator (RFM) Gait System
- Keywords
- Functional Electrical Stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radio frequency-controlled (RF) Microstimulator (RFM) Gait SystemDevice
Fully Implanted FES system to assist patient with gait component practice
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | radio frequency-controlled (RF) Microstimulator (RFM) Gait System Receives: Device: radio frequency-controlled (RF) Microstimulator (RFM) Gait System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Endurance (6MWT)
The Six Minute Walk Test (6MWT) is a measure of the distance measured in feet ambulated by the participant during six minutes. A further distance walked in 6 minutes indicates improvement on the measure.
Measured: Day 1 and at 3 months, following treatment
Kinematic Gait Measures
assessment of the lower limb kinematics during ambulation at chosen speed.
Measured: Day 1 and at 3 months, following treatment
Secondary outcomes (4)
Fugl-Meyer Lower Extremity Score
Fugl-Meyer Lower Extremity Score (FMLE) is an itemized measure of lower extremity coordination following stroke. Scores for the FMLE range from 0 (most impaired) to 34 (normal).
Measured: Day 1 and at 3 months, following treatment
Ashworth Scale
The Ashworth Scale is a measure of muscle spasticity; muscle groups are graded from 0 (no spasticity) to 4 (greatest spasticity/contracture). The lower limb muscle groups are summed for a total lower limb Ashworth score. A lower score indicates better performance. (range is 0-40)
Measured: Day 1 and at 3 months, following treatment
Stroke Impact Scale (SIS)
The SIS is a measure of Quality of Life/Life Role Participation following stroke. Each item in a domain is scored between 0 and 5. A higher score indicates better performance (range 0-295).
Measured: Day 1 and at 3 months, following treatment
Manual Muscle Testing (MMT)
This is a measure of strength of the various muscle groups of the lower limb. Each is graded on a 0 to 5 scale; the final score is the summed total of the lower limb muscle groups tested. (score range of summed muscles is 0-50, with 50 being the maximum highest score)
Measured: Day 1 and at 3 months, following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: The enrollment period/study duration had exceeded The Alfred Mann Foundation's timeline.
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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- The Alfred E. Mann Foundation for Scientific Research
- Responsible party
- Sponsor
- Investigators
- Janis Daly, PhD MS, Principal investigator, VA Medical Center-Cleveland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864708
- Sponsor's protocol ID
- B3252-R
- Other IDs
- B3513R
- Status last verified
- May 2014
- First submitted
- 17 Mar 2009
- Last updated
- 26 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008
- ClinicalTrials.gov ID
- NCT00864708
- Acronym / sponsor ID
- B3252-R
- Conditions
- Stroke
- Keywords
- Functional Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The enrollment period/study duration had exceeded The Alfred Mann Foundation's timeline.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- The Alfred E. Mann Foundation for Scientific Research
- Study start
- Dec 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Posted 26 May 2014
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 the study is to investigate new Technology for recovery of ankle walking function after stroke.
Detailed description
Background and Purpose: Conventional rehabilitation does not restore normal, upper limb function or normal gait to many stroke survivors. Functional neuromuscular stimulation (FNS) has shown promise for functional enhancement of both upper and lower limb motor control following stroke. Gains included muscle activation latencies, strength, coordination, upper limb functional tasks, gait kinematics, walking endurance, and quality of life. The purpose of the proposed work is to test the radio frequency-controlled (RF) Microstimulator (RFM) Gait System regarding system performance and subject response to treatment.
Methods: This is a feasibility study in which up to four subjects will receive the (RFM) Gait System. Up to ten RFMs will be placed for a given subject. An RFM ankle muscle system will be used to train ankle gait components. A separate RFM system will be used to train knee gait components. Subjects will be treated for 6 months, four sessions/wk. Primary outcome measures for the RFM Gait System will be: kinematic swing phase gait components and walking endurance. Secondary outcome measures will include: strength, coordination, spasticity, function, and quality of life. Data collections will occur at months 1, 3 and 6, and for follow-up times up to a year after the end of treatment. The results of the RFM ankle system have the potential to provide a new technology for ankle muscle gait components.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: radio frequency-controlled (RF) Microstimulator (RFM) Gait Systemradio frequency-controlled (RF) Microstimulator (RFM) Gait System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sufficient endurance to participate in rehabilitation sessions.
- Medically Stable
- Age >21 years.
- Inability to perform normal ankle coordinated gait components.
- Participants should be able to walk and keep balance without physical assistance from another person
Key exclusion criteria (5 listed)
- Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy.
- Lower motor neuron damage or radiculopathy
- Allergy or contraindication to anesthesia, Versed, (or comparable substitute.
- Active implantable device (e.g. pacemaker, implantable cardiac defibrillator, neurostimulator, or drug infusion device.
- Pregnancy
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 |
|---|---|---|
| radio frequency-controlled (RF) Microstimulator (RFM) Gait SystemFully Implanted FES system to assist patient with gait component practice | Device | Arm 1 |
Primary outcome
Walking Endurance (6MWT)
Time frame: Day 1 and at 3 months, following treatment
The Six Minute Walk Test (6MWT) is a measure of the distance measured in feet ambulated by the participant during six minutes. A further distance walked in 6 minutes indicates improvement on the measure.
Kinematic Gait Measures
Time frame: Day 1 and at 3 months, following treatment
assessment of the lower limb kinematics during ambulation at chosen speed.
4 secondary outcomes
Fugl-Meyer Lower Extremity Score
Time frame: Day 1 and at 3 months, following treatment
Ashworth Scale
Time frame: Day 1 and at 3 months, following treatment
Stroke Impact Scale (SIS)
Time frame: Day 1 and at 3 months, following treatment
Manual Muscle Testing (MMT)
Time frame: Day 1 and at 3 months, following treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
- 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.
Janis Daly, PhD MS principal investigator
VA Medical Center-Cleveland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stroke, run by US Department of Veterans Affairs 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 26 May 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 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?
Walking Endurance (6MWT) (time frame: Day 1 and at 3 months, following treatment). 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 26 May 2014.