HemiplegiaNCT00991406
Neural Prostheses and Gait Performance: Model-Based Strategies
A study testing FES in people with Hemiplegia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this research is to find the optimal patterns of functional electrical stimulation (FES) of muscles in the lower legs that will improve walking ability in those who have had a stroke and at the same time ensure walking stability. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemiplegia
- What is being tested?
- FES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Nov 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- This study includes stroke survivors greater than 18 years of age, >180 days from first clinical hemorrhagic or nonhemorrhagic stroke with:
- Unilateral hemiparesis with sufficient endurance and motor ability to ambulate >30 feet continuously without an AFO requiring no more than 25% physical help
- Berg Balance Scale score >23 without assistive devices
- Standing ankle dorsiflexion strength of <4/5
- Foot-drop during ambulation with gait instability or inefficient gait defined as supervision need
- Possible use of physical assistance or assistive device (cane, walker)
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- Evidence of foot-drop as seen by "dragging" or "catching" of affected toes during limb swing or circumducting affected limb
- Vaulting of the unaffected limb or hiking the affected hip to clear toes.
- Intact and electrically ex-citable lower motor neurons
- Ankle dorsiflexion to at least neutral while standing with electrical stimulation of common peroneal and tibial nerves without painful hypersensitivity to stimulation
- Adequate social support and stability
- Medically stable with intact skin in affected lower limb
- Willingness to comply during research procedures
- No systemic co-morbidities
- No history of potentially fatal cardiac arrhythmias i.e. ventricular tachycardia, supraventricular tachycardia and rapid ventricular response atrial fibrillation with hemodynamic instability
- No psychological problems or chemical dependency
- No acute medical complications such as depression or chronic anxiety requiring long term pharmacological therapy. Able-bodied controls must be of similar age, body mass and stature as those with hemiparesis and must be free of any medical and disabling orthopedic problems.
Who cannot join
- In addition to failure to meet the inclusion criteria, participants will be excluded from the study for the following:
- Requires an ankle foot orthosis (AFO) to prevent knee flexion collapse in stance
- Excessive edema of affected extremity
- Absent sensation in affected limb
- History of potentially fatal cardiac arrhythmias such as ventricular tachycardia, supraventricular tachycardia, and rapid ventricular response, atrial fibrillation with hemodynamic instability
- Demand pacemakers or any implanted electronic systems
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- Pregnancy
- Uncontrolled seizure disorder
- Ipsilateral lower limb lower motor neuron lesion
- Parkinson's disease
- Spinal cord injury
- Traumatic brain injury
- Multiple sclerosis
- Ankle plantar flexor contraction
- Severely impaired cognition and communication
- Painful hypersensitivity to neuromuscular stimulation of common peroneal nerve
- Knee hyperextension (genu recurvatum) that cannot be adequately corrected with peroneal nerve stimulation
- History of botulinum toxin to the lower extremity within the prior three months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
About this study
The purpose of this research is to find the optimal patterns of functional electrical stimulation (FES) of muscles in the lower legs that will improve walking ability in those who have had a stroke and at the same time ensure walking stability. FES involves applying small electric currents to the nerves, which cause the muscles to contract.
FES research projects vary from simple investigations of the therapeutic effects of exercise on muscle function and skin health, to more complex studies of functional movements such as standing or walking.
Read the detailed description
The study aims to find the optimal patterns of functional electrical stimulation (FES) of muscles in the lower legs that will improve walking ability in those who have had a stroke and at the same time ensure walking stability will be achieved through an analytical approach comprised of computational models and gait simulations to objectively determine patient-specific patterns of muscle activation. The investigators will develop a computer simulation of the dynamics of hemiplegic gait characterized by unilateral plantarflexor weakness. Then, the investigators will relate the results of the computer model results to real data collected from subjects with known plantarflexor weakness to provide a theoretical basis for improving gait efficiency and stability with FES.
- Conditions
- Hemiplegia
- Being tested
- FES
- Keywords
- Electric Stimulation, Hemiplegia, walking
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FESDevice
Surface stimulation to contract the muscles in the lower extremity
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: FES | Experimental | Case-control study: pre- and post-stimulation (FES). Receives: Device: FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Stability and Speed
This was a feasibility study of computational models and gait simulations to objectively determine patient-specific patterns of muscle activation. We developed computer models and walking simulations of hemiplegic gait from 8 subjects. We related the model results (muscle activations) to the optimized data collected from hemiplegic subjects \& calculated the FES pattern to be delivered in 2 forms (open loop \& foot switch triggered). The primary outcome measure turned out to be the feasibility of the methods because after developing our computer modeling and computational optimization framework we could only test walking with the 2 forms of FES at the same preferred walking speed on a treadmill. Thus, the simulated walking speed and the real walking speed pre and post FES turned out to be the same. Walking stability was measured with variability in work performed at the ankle. The additional volitional and FES biomechanical data that were measured are listed in the secondary measures.
Measured: pre-stimulation (volitional) and post-stimulation (FES), day of the study
Secondary outcomes (3)
Peak Ankle Power
This is the peak ankle power during walking normalized by body weight.
Measured: Same day: pre-stimulation (volitional) and post-stimulation (FES), day of the study
Positive Ankle Work
This is the amount of positive work performed by the ankle during walking normalized by body mass.
Measured: Same day; pre-stimulation (volitional) and post-stimulation (FES), day of the study
The Impulse of the Anterior Ground Reaction Force Normalized by Body Mass.
The is the magnitude of ground reaction force over time per step in the anterior direction during walking.
Measured: Same day: pre-stimulation (volitional) and post-stimulation (FES), day of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2016
- Study completionNov 2016
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 HemiplegiaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Elizabeth C Hardin van den Bogert, PhD MS, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991406
- Sponsor's protocol ID
- B4668-R
- Status last verified
- Jul 2019
- First submitted
- 2 Oct 2009
- Last updated
- 9 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Prostheses and Gait Performance: Model-Based Strategies
- ClinicalTrials.gov ID
- NCT00991406
- Acronym / sponsor ID
- B4668-R
- Conditions
- Hemiplegia
- Keywords
- Electric Stimulation, Hemiplegia, walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jun 2009
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Oct 2009 (estimated)
- Results
- Posted 9 Aug 2019
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 is to find the optimal patterns of functional electrical stimulation (FES) of muscles in the lower legs that will improve walking ability in those who have had a stroke and at the same time ensure walking stability. FES involves applying small electric currents to the nerves, which cause the muscles to contract.
FES research projects vary from simple investigations of the therapeutic effects of exercise on muscle function and skin health, to more complex studies of functional movements such as standing or walking.
Detailed description
The study aims to find the optimal patterns of functional electrical stimulation (FES) of muscles in the lower legs that will improve walking ability in those who have had a stroke and at the same time ensure walking stability will be achieved through an analytical approach comprised of computational models and gait simulations to objectively determine patient-specific patterns of muscle activation. The investigators will develop a computer simulation of the dynamics of hemiplegic gait characterized by unilateral plantarflexor weakness. Then, the investigators will relate the results of the computer model results to real data collected from subjects with known plantarflexor weakness to provide a theoretical basis for improving gait efficiency and stability with FES.
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: FES | Experimental | Device: FESCase-control study: pre- and post-stimulation (FES). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- This study includes stroke survivors greater than 18 years of age, >180 days from first clinical hemorrhagic or nonhemorrhagic stroke with:
- Unilateral hemiparesis with sufficient endurance and motor ability to ambulate >30 feet continuously without an AFO requiring no more than 25% physical help
- Berg Balance Scale score >23 without assistive devices
- Standing ankle dorsiflexion strength of <4/5
- Foot-drop during ambulation with gait instability or inefficient gait defined as supervision need
Key exclusion criteria (18 listed)
- In addition to failure to meet the inclusion criteria, participants will be excluded from the study for the following:
- Requires an ankle foot orthosis (AFO) to prevent knee flexion collapse in stance
- Excessive edema of affected extremity
- Absent sensation in affected limb
- History of potentially fatal cardiac arrhythmias such as ventricular tachycardia, supraventricular tachycardia, and rapid ventricular response, atrial fibrillation with hemodynamic instability
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 |
|---|---|---|
| FESSurface stimulation to contract the muscles in the lower extremity | Device | Arm 1: FES |
Primary outcome
Walking Stability and Speed
Time frame: pre-stimulation (volitional) and post-stimulation (FES), day of the study
This was a feasibility study of computational models and gait simulations to objectively determine patient-specific patterns of muscle activation. We developed computer models and walking simulations of hemiplegic gait from 8 subjects. We related the model results (muscle activations) to the optimized data collected from hemiplegic subjects \& calculated the FES pattern to be delivered in 2 forms (open loop \& foot switch triggered). The primary outcome measure turned out to be the feasibility of the methods because after developing our computer modeling and computational optimization framework we could only test walking with the 2 forms of FES at the same preferred walking speed on a treadmill. Thus, the simulated walking speed and the real walking speed pre and post FES turned out to be the same. Walking stability was measured with variability in work performed at the ankle. The additional volitional and FES biomechanical data that were measured are listed in the secondary measures.
3 secondary outcomes
Peak Ankle Power
Time frame: Same day: pre-stimulation (volitional) and post-stimulation (FES), day of the study
Positive Ankle Work
Time frame: Same day; pre-stimulation (volitional) and post-stimulation (FES), day of the study
The Impulse of the Anterior Ground Reaction Force Normalized by Body Mass.
Time frame: Same day: pre-stimulation (volitional) and post-stimulation (FES), day of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Elizabeth C Hardin van den Bogert, PhD MS principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES in people with Hemiplegia, run by VA Office of Research and Development 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 17 inclusion and 18 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 9 Aug 2019. 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 9 Aug 2019). 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 Stability and Speed (time frame: pre-stimulation (volitional) and post-stimulation (FES), day of the study). 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 9 Aug 2019; AzTrials last refreshed its copy on 30 Oct 2026.