StrokeNCT00508755
Feasibility and Practice Characteristics of FNS and Gait Robot
A study testing Gait Robot and Functional Neuromuscular stimulation with intramuscular electrodes in people with Stroke, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Conventional therapies do not restore normal gait for many stroke survivors. The long-term goal of this work is to restore volitional lower limb motor control and gait following stroke. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Gait Robot and Functional Neuromuscular stimulation with intramuscular electrodes
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Aug 2009
- 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
- Greater than or equal to 6 months after stroke
- 21 years or older
- Ability to follow 2 step commands
- Inability to move leg normally
Who cannot join
- Pacemaker
- Progressive medical condition (i.e. Parkinsons Disease)
Trial locations and contacts
1 site in 1 country.
About this study
Conventional therapies do not restore normal gait for many stroke survivors. The long-term goal of this work is to restore volitional lower limb motor control and gait following stroke. In our prior work, we demonstrated that it was feasible to provide a clinically operated, combined treatment of body weight supported treadmill training alone (BWSTT) + functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM).
Specific Aims and Hypothesis The purpose or Specific Aim of the study is to test the feasibility and gait training potential of combining the Lokomat and FNS-IM for stroke survivors. Given the feasibility of our clinically operated combination of BWSTT + FNS-IM, we propose to test the feasibility of the combination of Lokomat + FNS-IM.
Read more
Hypothesis I. It is feasible to utilize a clinically operated combination of Lokomat + functional neuromuscular stimulation (FNS) with intramuscular (IM) electrodes (FNS-IM).
Treatment Procedures. The subjects will be treated for three months, four sessions/week (for a total of 48 treatment visits). A given session will be 1 hrs, with the time divided into thirds as follows: 1) hr coordination exercise; 2) hr over ground gait training; and 3) hr Lokomat gait training. FNS-IM will be used in all three aspects of the protocol, unless the subject is capable of volitionally executing a given movement or gait component. Population. The subjects will be chronic stroke survivors (>6 months after the stroke).
- Conditions
- Stroke
- Being tested
- Gait Robot, Functional Neuromuscular stimulation with intramuscular electrodes
- Keywords
- cerebrovascular accident, electrical stimulation, gait training, motor learning
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait RobotDevice
gait training with the use of a gait robot
Functional Neuromuscular stimulation with intramuscular electrodesDevice
gait training with use of functional electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | stroke Receives: Device: Gait Robot; Device: Functional Neuromuscular stimulation with intramuscular electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES.
Observational Gait components during stance and swing phase, for pelvis, hip, knee, and ankle for each of the six participants was observed during the following conditions: Gait Robot-alone, FES-alone, and combined Gait Robot and FES.
Measured: visit 48, following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startAug 2005
- Primary completionJun 2009
- Study completionAug 2009
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.
- Publications (2)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Janis Daly, PhD MS, Principal investigator, VA Medical Center-Cleveland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508755
- Sponsor's protocol ID
- B4036-I
- Status last verified
- Apr 2014
- First submitted
- 27 Jul 2007
- Last updated
- 25 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McCabe JP, Dohring ME, Marsolais EB, Rogers J, Burdsall R, Roenigk K, Pundik S, Daly JJ. Feasibility of combining gait robot and multichannel functional electrical stimulation with intramuscular electrodes. J Rehabil Res Dev. 2008;45(7):997-1006. doi: 10.1682/jrrd.2007.08.0124.
PubMed 19165689Dohring ME, Daly JJ. Automatic synchronization of functional electrical stimulation and robotic assisted treadmill training. IEEE Trans Neural Syst Rehabil Eng. 2008 Jun;16(3):310-3. doi: 10.1109/TNSRE.2008.920081.
PubMed 18586610
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Practice Characteristics of FNS and Gait Robot
- ClinicalTrials.gov ID
- NCT00508755
- Acronym / sponsor ID
- B4036-I
- Conditions
- Stroke
- Keywords
- cerebrovascular accident, electrical stimulation, gait training, motor learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 30 Jul 2007 (estimated)
- Results
- Posted 2 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conventional therapies do not restore normal gait for many stroke survivors. The long-term goal of this work is to restore volitional lower limb motor control and gait following stroke. In our prior work, we demonstrated that it was feasible to provide a clinically operated, combined treatment of body weight supported treadmill training alone (BWSTT) + functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM).
Specific Aims and Hypothesis The purpose or Specific Aim of the study is to test the feasibility and gait training potential of combining the Lokomat and FNS-IM for stroke survivors. Given the feasibility of our clinically operated combination of BWSTT + FNS-IM, we propose to test the feasibility of the combination of Lokomat + FNS-IM.
Hypothesis I. It is feasible to utilize a clinically operated combination of Lokomat + functional neuromuscular stimulation (FNS) with intramuscular (IM) electrodes (FNS-IM).
Treatment Procedures. The subjects will be treated for three months, four sessions/week (for a total of 48 treatment visits). A given session will be 1 hrs, with the time divided into thirds as follows: 1) hr coordination exercise; 2) hr over ground gait training; and 3) hr Lokomat gait training. FNS-IM will be used in all three aspects of the protocol, unless the subject is capable of volitionally executing a given movement or gait component. Population. The subjects will be chronic stroke survivors (>6 months after the stroke).
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: Gait Robot, Device: Functional Neuromuscular stimulation with intramuscular electrodesstroke |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Greater than or equal to 6 months after stroke
- 21 years or older
- Ability to follow 2 step commands
- Inability to move leg normally
Key exclusion criteria (2 listed)
- Pacemaker
- Progressive medical condition (i.e. Parkinsons Disease)
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 |
|---|---|---|
| Gait Robotgait training with the use of a gait robot | Device | Arm 1 |
| Functional Neuromuscular stimulation with intramuscular electrodesgait training with use of functional electrical stimulation | Device | Arm 1 |
Primary outcome
Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES.
Time frame: visit 48, following treatment
Observational Gait components during stance and swing phase, for pelvis, hip, knee, and ankle for each of the six participants was observed during the following conditions: Gait Robot-alone, FES-alone, and combined Gait Robot and FES.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19165689McCabe JP, Dohring ME, Marsolais EB, Rogers J, Burdsall R, Roenigk K, Pundik S, Daly JJ. Feasibility of combining gait robot and multichannel functional electrical stimulation with intramuscular electrodes. J Rehabil Res Dev. 2008;45(7):997-1006. doi: 10.1682/jrrd.2007.08.0124.
- Results publication: PubMed 18586610Dohring ME, Daly JJ. Automatic synchronization of functional electrical stimulation and robotic assisted treadmill training. IEEE Trans Neural Syst Rehabil Eng. 2008 Jun;16(3):310-3. doi: 10.1109/TNSRE.2008.920081.
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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 testing Gait Robot and Functional Neuromuscular stimulation with intramuscular electrodes in people with 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 4 inclusion and 2 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 25 Apr 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 2 Apr 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?
Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. (time frame: visit 48, following treatment). 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 NCT00508755, which also lists 2 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 25 Apr 2014.