StrokeNCT02797886
Pairing Functional Electrical Stimulation (FES) and Volitional Effort Training Promotes Neuroplasticity and Motor Gain
A study testing FES + VOL, FES and VOL in people with Stroke and Drop Foot, run by Kessler Foundation.
Trial summary
The goal of the study is to explore the effect of combined training involving functional electrical stimulation (FES) of the ankle dorsal flexor with simultaneous maximal-effort voluntary contraction of the same muscle to correct or improve foot drop in chronic stroke patients. Read more about this study
- Who is it for?
- Ages 10 to 90 years
- What is being tested?
- FES + VOL, FES and VOL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2017
- Phase
- Interventional
- 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 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be hemiplegic secondary to stroke and exhibit foot drop (as diagnosed by the participant's treating physician)
- Between the ages of 10 and 90.
- Must have sustained a stroke at least 6 months prior to enrollment.
- Uninvolved lower limb must have no history of injury or pathology within the last 90 days.
- Must be able to walk independently for 10 meters.
- Must have inadequate dorsiflexion during the swing phase of gait resulting in inadequate limb clearance
- Medically stable for three months prior to the most recent episode of stroke resulting in hemiplegia or hemiparesis with foot drop
- Adequate cognitive function to give informed consent, understand instructions, and give adequate feedback.
Who cannot join
- Individuals with additional orthopedic, neuromuscular, or neurological pathologies that would interfere with their ability to walk
- Individuals with previous use of FES for community ambulation (neuroprosthesis) or clinical treatment <1 year will be excluded from participation due to possible confounding effects
- Severe cardiac disease such as myocardial infarction, or congestive heart failure
- Fixed ankle contractures of ten degrees of plantarflexion with knee extended
- Pre-existing pathology resulting in a significant disruption in alignment or function of the lower extremity
- Excessive dysesthetic pain secondary to neurological involvement
- Severe hypertonicity resulting in the need for more involved rehabilitation strategies
- Participants will not be excluded due to gender or ethnicity.
Trial locations and contacts
No sites are listed yet.
About this study
The goal of the study is to explore the effect of combined training involving functional electrical stimulation (FES) of the ankle dorsal flexor with simultaneous maximal-effort voluntary contraction of the same muscle to correct or improve foot drop in chronic stroke patients. Participants will be assessed for functional motor ability and neurological function during their first visit and then again after five and then ten weeks of training. Functional motor ability is broken down into dorsiflexion strength and general gait analysis. Dorsiflexion strength is measured by use of a dynamometer. Gait is assessed via recordings of electromyography, pedobarography, kinematic, and various functional variables during 10 walking trials. The neurological assessment will include electroencephalographic (EEG) analysis of movement-related cortical potentials (MRCP), somatosensory evoked potentials (SSEP), and M-wave response to stimulation. Participants will be randomly assigned to one of three groups: 1) FES + volitional movement (VOL), 2) FES alone, and 3) VOL alone, which will determine their training regimen. The training sessions involve roughly 20 minutes of repeated muscle contractions (with appropriate breaks to avoid fatigue). The participants assigned to the FES+VOL group will receive electrical stimulation to the peroneal nerve in concert with volitional dorsiflexion, whereas the other groups will either dorsiflex voluntarily with no stimulation or receive stimulation while being asked to do nothing.
- Being tested
- FES + VOL, FES, VOL
- Keywords
- Hemiplegia, Drop foot, Foot drop
- Medical subject headings
- Stroke, Peroneal Neuropathies, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES + VOLOther
Electrical stimulation is applied in concert with the subject's volitional movement.
FESOther
Electrical stimulation is applied to the subject while they are asked to do nothing.
VOLOther
The subject initiates and completes the movement without electrical stimulation.
| Study group | Role | What they receive |
|---|---|---|
| FES+VOL | Experimental | Electrical stimulation (FES) in concert with volitional effort. The subject is visually cued to initiate the movement and when they begin the movement (as ascertained by EMG response), the stimulation is immediately applied until the completion of the trial. Receives: Other: FES + VOL |
| FES | Active comparator | Electrical stimulation alone. The subject is asked to do nothing as electrical stimulation initiates and completes the movement for them. Receives: Other: FES |
| VOL | Active comparator | Volitional effort alone. When cued, the subject initiates and completes the movement on their own until the completion of the trial. There is no electrical stimulation in this group. Receives: Other: VOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force Produced by Voluntary Dorsiflexion
Measured: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Time to Complete 10 Meter Walk
Measured: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Center of Pressure of Plantar Loading During Walking Trial
Measured: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Joint Angles During Walking Trial
Sagittal (flexion and extension), frontal (abduction and adduction) and transverse (internal and external rotation) plane angles of the ankle, knee, and hip.
Measured: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Amplitude of the Major Components of Somatosensory Evoked Potentials
Amplitude of the N1, N2, P1, and P2 components of artifact free epochs
Measured: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Amplitude of the P40-N50 Complex During Movement Related Cortical Potentials
Measured: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Amplitude and Latency of M-Wave Component of EMG During Maximal Voluntary Contraction
Measured: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797886
- Sponsor's protocol ID
- R-806-13
- Status last verified
- Jun 2016
- First submitted
- 31 May 2016
- Last updated
- 14 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pairing Functional Electrical Stimulation (FES) and Volitional Effort Training Promotes Neuroplasticity and Motor Gain
- ClinicalTrials.gov ID
- NCT02797886
- Acronym / sponsor ID
- R-806-13
- Keywords
- Hemiplegia, Drop foot, Foot drop
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- First posted
- 14 Jun 2016 (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 goal of the study is to explore the effect of combined training involving functional electrical stimulation (FES) of the ankle dorsal flexor with simultaneous maximal-effort voluntary contraction of the same muscle to correct or improve foot drop in chronic stroke patients. Participants will be assessed for functional motor ability and neurological function during their first visit and then again after five and then ten weeks of training. Functional motor ability is broken down into dorsiflexion strength and general gait analysis. Dorsiflexion strength is measured by use of a dynamometer. Gait is assessed via recordings of electromyography, pedobarography, kinematic, and various functional variables during 10 walking trials. The neurological assessment will include electroencephalographic (EEG) analysis of movement-related cortical potentials (MRCP), somatosensory evoked potentials (SSEP), and M-wave response to stimulation. Participants will be randomly assigned to one of three groups: 1) FES + volitional movement (VOL), 2) FES alone, and 3) VOL alone, which will determine their training regimen. The training sessions involve roughly 20 minutes of repeated muscle contractions (with appropriate breaks to avoid fatigue). The participants assigned to the FES+VOL group will receive electrical stimulation to the peroneal nerve in concert with volitional dorsiflexion, whereas the other groups will either dorsiflex voluntarily with no stimulation or receive stimulation while being asked to do nothing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FES+VOL | Experimental | Other: FES + VOLElectrical stimulation (FES) in concert with volitional effort. The subject is visually cued to initiate the movement and when they begin the movement (as ascertained by EMG response), the stimulation is immediately applied until the completion of the trial. |
| FES | Active comparator | Other: FESElectrical stimulation alone. The subject is asked to do nothing as electrical stimulation initiates and completes the movement for them. |
| VOL | Active comparator | Other: VOLVolitional effort alone. When cued, the subject initiates and completes the movement on their own until the completion of the trial. There is no electrical stimulation in this group. |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Must be hemiplegic secondary to stroke and exhibit foot drop (as diagnosed by the participant's treating physician)
- Between the ages of 10 and 90.
- Must have sustained a stroke at least 6 months prior to enrollment.
- Uninvolved lower limb must have no history of injury or pathology within the last 90 days.
- Must be able to walk independently for 10 meters.
Key exclusion criteria (8 listed)
- Individuals with additional orthopedic, neuromuscular, or neurological pathologies that would interfere with their ability to walk
- Individuals with previous use of FES for community ambulation (neuroprosthesis) or clinical treatment <1 year will be excluded from participation due to possible confounding effects
- Severe cardiac disease such as myocardial infarction, or congestive heart failure
- Fixed ankle contractures of ten degrees of plantarflexion with knee extended
- Pre-existing pathology resulting in a significant disruption in alignment or function of the lower extremity
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 |
|---|---|---|
| FES + VOLElectrical stimulation is applied in concert with the subject's volitional movement. | Other | FES+VOL |
| FESElectrical stimulation is applied to the subject while they are asked to do nothing. | Other | FES |
| VOLThe subject initiates and completes the movement without electrical stimulation. | Other | VOL |
Primary outcome
Force Produced by Voluntary Dorsiflexion
Time frame: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Time to Complete 10 Meter Walk
Time frame: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Center of Pressure of Plantar Loading During Walking Trial
Time frame: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Joint Angles During Walking Trial
Time frame: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Sagittal (flexion and extension), frontal (abduction and adduction) and transverse (internal and external rotation) plane angles of the ankle, knee, and hip.
Amplitude of the Major Components of Somatosensory Evoked Potentials
Time frame: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Amplitude of the N1, N2, P1, and P2 components of artifact free epochs
Amplitude of the P40-N50 Complex During Movement Related Cortical Potentials
Time frame: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Amplitude and Latency of M-Wave Component of EMG During Maximal Voluntary Contraction
Time frame: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing FES + VOL, FES and VOL in people with Stroke and Drop Foot, run by Kessler Foundation.
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 8 inclusion and 8 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 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Greg Ames (9732436816 ext. 6816, games@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Force Produced by Voluntary Dorsiflexion (time frame: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention). The study lists 7 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 14 Jun 2016.