StrokeNCT00148343
Functional Electrical Stimulation for Footdrop in Hemiparesis
A study testing Odstock Dropped-Foot Stimulator (ODFS) and Traditional Physical Therapy Treatment in people with Stroke and Hemiplegia, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
The objective of this research is to determine if electrical stimulation can improve the strength and coordination of the lower limb muscles, and the walking ability of stroke survivors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- Odstock Dropped-Foot Stimulator (ODFS) and Traditional Physical Therapy Treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to 2 Aug 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke survivors >90 days from most recent clinical hemorrhagic or nonhemorrhagic stroke
- Age: 18-80 years
- Unilateral hemiparesis
- Medically stable
- Sufficient endurance \& motor ability to ambulate at least 30 feet continuously with minimal assistance [requiring contact guard to no more than 25% physical help] or less without the use of an AFO
- Berg Balance Scale score of 24 or greater without any assistive devices
Show all 10Show fewer
- Ankle dorsiflexion strength of no greater than 4/5 on the Medical Research Council (MRC) scale while standing
- Demonstrate foot-drop during ambulation such that gait instability [need for supervision, physical assistance or assistive device (cane, walker) to maintain balance or prevent falls] or inefficient gait patterns [gait pattern manifesting "dragging" or "catching" of the affected toes during swing phase of gait, or use of compensatory strategies such as circumducting the affected limb, vaulting with the unaffected limb or hiking the affected hip to clear the toes] are exhibited
- Ankle dorsiflexion to at least neutral while standing in response to NMES of the common peroneal nerve without painful hypersensitivity to the NMES
- If using an AFO, willing to terminate its use and comply with study requirements
Who cannot join
- Require an AFO to maintain knee stability (prevention of knee flexion collapse) during stance phase of gait
- Edema of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator
- Skin breakdown of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator
- Absent sensation of the affected lower 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 other implanted electronic systems
Show all 20Show fewer
- Pregnant women
- Uncontrolled seizure disorder
- Parkinson's Disease
- Spinal cord injury
- Traumatic brain injury with evidence of motor weakness
- Multiple sclerosis
- Fixed ankle plantar flexor contracture
- Peroneal nerve injury at the fibular head as the cause of foot-drop
- Uncompensated hemineglect
- Severely impaired cognition and communication
- Painful hypersensitivity to NMES of the common peroneal nerve
- Inadequate social support (potential unlikeliness to comply with treatment \& follow-up)
- History of Botulinum toxin (Botox) injection to either of the lower extremities within the 3 month period preceding study entry
- Knee hyperextension (genu recurvatum) that cannot be adequately corrected with peroneal nerve stimulation
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this research is to determine if electrical stimulation can improve the strength and coordination of the lower limb muscles, and the walking ability of stroke survivors.
The knowledge gained from this study may lead to enhancements in the quality of life of stroke survivors by improving their neurological recovery and mobility. The results may lead to substantial changes in the standard of care for the treatment of lower limb hemiparesis after stroke.
Read the detailed description
Hemiplegia is a major consequence of stroke and contributes significantly to the physical disability of stroke survivors. Foot-drop, or inability to dorsiflex the paretic ankle during the swing phase of gait, and ankle instability during stance phase, are important gait abnormalities that contribute to reduced mobility among stroke survivors. In the United States, the standard of care in addressing these deficits is the custom molded ankle-foot-orthosis (AFO). However, evolving data now demonstrate that active repetitive movement training is the principal substrate for facilitating motor relearning after stroke. Motor relearning is defined as the reacquisition of motor ability after central nervous system injury. Thus, while an AFO may assist stroke survivors to ambulate in the short-term, it is possible that it also inhibits recovery in the long-term. Previous studies have demonstrated that active repetitive movement exercises mediated by neuromuscular electrical stimulation (NMES) facilitate motor relearning among stroke survivors. In particular, studies have reported that some chronic stroke survivors treated with a peroneal nerve stimulator for foot-drop experience sufficient recovery that they no longer need the peroneal nerve stimulator or an AFO for community ambulation. However, there are no blinded randomized clinical trials that rigorously evaluate the motor relearning effects of ambulation training with peroneal nerve stimulators. Thus, the primary aim of this project is to assess the effects of transcutaneous peroneal nerve stimulation on lower limb motor relearning among chronic stroke survivors. The secondary aim is to assess the effects of transcutaneous peroneal nerve stimulation on lower limb mobility (disability) and overall quality of life. A single-blinded randomized clinical trial will be carried out to assess the effects of ambulation training with a peroneal nerve stimulator among chronic stroke survivors compared to ambulation training with conventional standard of care (which may include an AFO). Subjects will be treated for 12 weeks and followed for a total of another 6 months. This project will determine the effectiveness of peroneal nerve stimulation in facilitating motor relearning and improving the mobility and quality of life of stroke survivors. This proposed approach is expected to improve patient outcome and challenge the present clinical paradigm of prescribing AFOs for stroke survivors with foot-drop.
- Conditions
- Stroke, Hemiplegia
- Being tested
- Odstock Dropped-Foot Stimulator (ODFS), Conventional Standard of Care, Traditional Physical Therapy Treatment
- Keywords
- hemiplegia, hemiparesis, stroke, foot-drop, electrical stimulation, ankle-foot-orthosis
- Medical subject headings
- Stroke, Hemiplegia, Paresis, Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Odstock Dropped-Foot Stimulator (ODFS)Device
Device implementation \& use for ~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The ODFS then will be returned to the investigators.
Conventional Standard of CareOther
Conventional standard of care (which may include implementation \& use of a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO)) for ~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The AFO, if implemented, may continue to be used afterwards since it is an element of the standard of care for this patient population.
Traditional Physical Therapy TreatmentProcedure or surgery
Traditional physical therapy treatment for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ODFS | Experimental | Odstock Dropped-Foot Stimulator (ODFS) Receives: Device: Odstock Dropped-Foot Stimulator (ODFS); Procedure: Traditional Physical Therapy Treatment |
| Standard of Care (inc. AFO) | Active comparator | Conventional Standard of Care (which may include a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO)) [Traditional Physical Therapy Treatment] Receives: Other: Conventional Standard of Care; Procedure: Traditional Physical Therapy Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Motor Assessment (FMA)
Lower limb motor impairment as measured by the lower limb portion of the Fugl-Meyer Assessment (FMA) which consists of 17 items, with a maximum possible score of 34 points, with lower scores indicating higher impairment. Each item was answered using a 3-point ordinal scale (0 = cannot perform, 1 = can partially perform, 2 = can fully perform).
Measured: Weeks 0, 12, 24, 36
Secondary outcomes (4)
Steps Per Minute
The number of steps taken by participants in one minute
Measured: Weeks 0, 12, 24, 36
Modified Emory Functional Ambulation Profile(mEFAP)
The mEFAP comprises 5 individually timed tasks performed over different environmental terrains. The subtasks include (1) a 5-meter walk on a hard floor; (2) a 5-meter walk on a carpeted surface; (3) rising from a chair, a 3-meter walk, and return to a seated position (the "timed up-and-go" test); (4) traversing a standardized obstacle course; and (5) ascending and descending 5 stairs. The mEFAP is performed with or without the use of an orthotic device or an AD. Manual assistance (MA) is provided as necessary. The subject can use rails when climbing the stairs. The 5 timed subscores are added to derive a total score in seconds.
Measured: Weeks 0, 12, 24, 36
Stroke-Specific Quality of Life Scale (SS-QOL)
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items in 12 domains: Mobility, Energy, Upper extremity function, Work/productivity, Mood, Self-care, Social roles, Family roles, Vision, Language, Thinking, Personality. There are 11 subscales.
Items are rated on a 5-point Likert scale with higher scores indicate better functioning. The overall SS-QOL summary score (summation of all items) is presented here. Scores range from 49-245.
Measured: Weeks 0, 12, 24, 36
Gait Speed
Measured: baseline, 12, 24 and 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJul 2005
- Primary completion2 Aug 2010
- Study completion2 Aug 2010
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 (33)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Case Western Reserve University
- Responsible party
- Principal investigator, John Chae, MD, MetroHealth Medical Center
- Investigators
- John Chae, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148343
- Sponsor's protocol ID
- IRB04-00104
- Other IDs
- R01HD044816
- Status last verified
- May 2018
- First submitted
- 2 Sep 2005
- Last updated
- 1 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Burridge JH, Taylor PN, Hagan SA, Wood DE, Swain ID. The effects of common peroneal stimulation on the effort and speed of walking: a randomized controlled trial with chronic hemiplegic patients. Clin Rehabil. 1997 Aug;11(3):201-10. doi: 10.1177/026921559701100303.
PubMed 9360032Burridge J, Taylor P, Hagan S, Swain I. Experience of clinical use of the Odstock dropped foot stimulator. Artif Organs. 1997 Mar;21(3):254-60. doi: 10.1111/j.1525-1594.1997.tb04662.x.
PubMed 9148719Burridge JH, McLellan DL. Relation between abnormal patterns of muscle activation and response to common peroneal nerve stimulation in hemiplegia. J Neurol Neurosurg Psychiatry. 2000 Sep;69(3):353-61. doi: 10.1136/jnnp.69.3.353.
PubMed 10945810Burridge JH, Wood DE, Taylor PN, McLellan DL. Indices to describe different muscle activation patterns, identified during treadmill walking, in people with spastic drop-foot. Med Eng Phys. 2001 Jul;23(6):427-34. doi: 10.1016/s1350-4533(01)00061-3.
PubMed 11551819Taylor PN, Burridge JH, Dunkerley AL, Wood DE, Norton JA, Singleton C, Swain ID. Clinical use of the Odstock dropped foot stimulator: its effect on the speed and effort of walking. Arch Phys Med Rehabil. 1999 Dec;80(12):1577-83. doi: 10.1016/s0003-9993(99)90333-7.
PubMed 10597809Taylor PN, Burridge JH, Dunkerley AL, Lamb A, Wood DE, Norton JA, Swain ID. Patients' perceptions of the Odstock Dropped Foot Stimulator (ODFS). Clin Rehabil. 1999 Oct;13(5):439-46. doi: 10.1191/026921599677086409.
PubMed 10498351Taylor P, Burridge J. Functional Electrical Stimulation - the Odstock Dropped Foot Stimulator. In: Sassoon R, ed. Understanding Stroke: Pardoe Blacker Publishing Ltd, 2002:72-78.
Taylor P. The use of electrical stimulation for correction of dropped foot in subjects with upper motor neuron lesions. Advances in Clinical Neurosciences and Rehabilitation 2002; 2:16-18.
Chae J, Bethoux F, Bohine T, Dobos L, Davis T, Friedl A. Neuromuscular stimulation for upper extremity motor and functional recovery in acute hemiplegia. Stroke. 1998 May;29(5):975-9. doi: 10.1161/01.str.29.5.975.
PubMed 9596245Francisco G, Chae J, Chawla H, Kirshblum S, Zorowitz R, Lewis G, Pang S. Electromyogram-triggered neuromuscular stimulation for improving the arm function of acute stroke survivors: a randomized pilot study. Arch Phys Med Rehabil. 1998 May;79(5):570-5. doi: 10.1016/s0003-9993(98)90074-0.
PubMed 9596400Mann GE, Wright PA, Swain ID. Training effects of electrical stimulation and the conventional ankle foot orthosis in the correction of drop foot following stroke., 1st Annual Conference of FESnet, 2002.
Taylor P, Mann G, Swain I. Does prior use of an Ankle Foot Orthosis (AFO) effect the response to use of the Odstock Dropped Foot Stimulator?, Institute of Physics and Engineering in Medicine (IPEM) Annual Scientific Meeting, Bath, U.K., September 15-17, 2003:89-90.
Buurke JH, Roetenberg D, Kleissen RFM, Hermens HJ. Early recovery of gait after stroke, 3rd World Congress in Neurological Rehabilitation, Venice, Italy, April 2-6, 2002, 2002.
El-Hayek K, Quinn A, Berezovskiy R, Santing J, Harley M, Chae J. Relationship between lower limb motor impairment and ambulation function among chronic stroke survivors. Submitted.
Teasell RW, Bhogal SK, Foley NC, Speechley MR. Gait retraining post stroke. Top Stroke Rehabil. 2003 Summer;10(2):34-65. doi: 10.1310/UDXE-MJFF-53V2-EAP0.
PubMed 13680517
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation for Footdrop in Hemiparesis
- ClinicalTrials.gov ID
- NCT00148343
- Acronym / sponsor ID
- IRB04-00104
- Conditions
- Stroke, Hemiplegia
- Keywords
- hemiplegia, hemiparesis, stroke, foot-drop, electrical stimulation, ankle-foot-orthosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Case Western Reserve University
- Study start
- Jul 2005
- Primary completion
- 2 Aug 2010 (actual)
- Study completion
- 2 Aug 2010 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Posted 1 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this research is to determine if electrical stimulation can improve the strength and coordination of the lower limb muscles, and the walking ability of stroke survivors.
The knowledge gained from this study may lead to enhancements in the quality of life of stroke survivors by improving their neurological recovery and mobility. The results may lead to substantial changes in the standard of care for the treatment of lower limb hemiparesis after stroke.
Detailed description
Hemiplegia is a major consequence of stroke and contributes significantly to the physical disability of stroke survivors. Foot-drop, or inability to dorsiflex the paretic ankle during the swing phase of gait, and ankle instability during stance phase, are important gait abnormalities that contribute to reduced mobility among stroke survivors. In the United States, the standard of care in addressing these deficits is the custom molded ankle-foot-orthosis (AFO). However, evolving data now demonstrate that active repetitive movement training is the principal substrate for facilitating motor relearning after stroke. Motor relearning is defined as the reacquisition of motor ability after central nervous system injury. Thus, while an AFO may assist stroke survivors to ambulate in the short-term, it is possible that it also inhibits recovery in the long-term. Previous studies have demonstrated that active repetitive movement exercises mediated by neuromuscular electrical stimulation (NMES) facilitate motor relearning among stroke survivors. In particular, studies have reported that some chronic stroke survivors treated with a peroneal nerve stimulator for foot-drop experience sufficient recovery that they no longer need the peroneal nerve stimulator or an AFO for community ambulation. However, there are no blinded randomized clinical trials that rigorously evaluate the motor relearning effects of ambulation training with peroneal nerve stimulators. Thus, the primary aim of this project is to assess the effects of transcutaneous peroneal nerve stimulation on lower limb motor relearning among chronic stroke survivors. The secondary aim is to assess the effects of transcutaneous peroneal nerve stimulation on lower limb mobility (disability) and overall quality of life. A single-blinded randomized clinical trial will be carried out to assess the effects of ambulation training with a peroneal nerve stimulator among chronic stroke survivors compared to ambulation training with conventional standard of care (which may include an AFO). Subjects will be treated for 12 weeks and followed for a total of another 6 months. This project will determine the effectiveness of peroneal nerve stimulation in facilitating motor relearning and improving the mobility and quality of life of stroke survivors. This proposed approach is expected to improve patient outcome and challenge the present clinical paradigm of prescribing AFOs for stroke survivors with foot-drop.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ODFS | Experimental | Device: Odstock Dropped-Foot Stimulator (ODFS), Procedure: Traditional Physical Therapy TreatmentOdstock Dropped-Foot Stimulator (ODFS) |
| Standard of Care (inc. AFO) | Active comparator | Other: Conventional Standard of Care, Procedure: Traditional Physical Therapy TreatmentConventional Standard of Care (which may include a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO)) [Traditional Physical Therapy Treatment] |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Stroke survivors >90 days from most recent clinical hemorrhagic or nonhemorrhagic stroke
- Age: 18-80 years
- Unilateral hemiparesis
- Medically stable
- Sufficient endurance \& motor ability to ambulate at least 30 feet continuously with minimal assistance [requiring contact guard to no more than 25% physical help] or less without the use of an AFO
Key exclusion criteria (20 listed)
- Require an AFO to maintain knee stability (prevention of knee flexion collapse) during stance phase of gait
- Edema of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator
- Skin breakdown of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator
- Absent sensation of the affected lower 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 |
|---|---|---|
| Odstock Dropped-Foot Stimulator (ODFS)Device implementation \& use for ~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The ODFS then will be returned to the investigators. | Device | ODFS |
| Conventional Standard of CareConventional standard of care (which may include implementation \& use of a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO)) for ~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The AFO, if implemented, may continue to be used afterwards since it is an element of the standard of care for this patient population. | Other | Standard of Care (inc. AFO) |
| Traditional Physical Therapy TreatmentTraditional physical therapy treatment for 12 weeks. | Procedure or surgery | ODFS, Standard of Care (inc. AFO) |
Primary outcome
Fugl-Meyer Motor Assessment (FMA)
Time frame: Weeks 0, 12, 24, 36
Lower limb motor impairment as measured by the lower limb portion of the Fugl-Meyer Assessment (FMA) which consists of 17 items, with a maximum possible score of 34 points, with lower scores indicating higher impairment. Each item was answered using a 3-point ordinal scale (0 = cannot perform, 1 = can partially perform, 2 = can fully perform).
4 secondary outcomes
Steps Per Minute
Time frame: Weeks 0, 12, 24, 36
Modified Emory Functional Ambulation Profile(mEFAP)
Time frame: Weeks 0, 12, 24, 36
Stroke-Specific Quality of Life Scale (SS-QOL)
Time frame: Weeks 0, 12, 24, 36
Gait Speed
Time frame: baseline, 12, 24 and 36 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9360032Burridge JH, Taylor PN, Hagan SA, Wood DE, Swain ID. The effects of common peroneal stimulation on the effort and speed of walking: a randomized controlled trial with chronic hemiplegic patients. Clin Rehabil. 1997 Aug;11(3):201-10. doi: 10.1177/026921559701100303.
- Background: PubMed 9148719Burridge J, Taylor P, Hagan S, Swain I. Experience of clinical use of the Odstock dropped foot stimulator. Artif Organs. 1997 Mar;21(3):254-60. doi: 10.1111/j.1525-1594.1997.tb04662.x.
- Background: PubMed 10945810Burridge JH, McLellan DL. Relation between abnormal patterns of muscle activation and response to common peroneal nerve stimulation in hemiplegia. J Neurol Neurosurg Psychiatry. 2000 Sep;69(3):353-61. doi: 10.1136/jnnp.69.3.353.
- Background: PubMed 11551819Burridge JH, Wood DE, Taylor PN, McLellan DL. Indices to describe different muscle activation patterns, identified during treadmill walking, in people with spastic drop-foot. Med Eng Phys. 2001 Jul;23(6):427-34. doi: 10.1016/s1350-4533(01)00061-3.
- Background: PubMed 10597809Taylor PN, Burridge JH, Dunkerley AL, Wood DE, Norton JA, Singleton C, Swain ID. Clinical use of the Odstock dropped foot stimulator: its effect on the speed and effort of walking. Arch Phys Med Rehabil. 1999 Dec;80(12):1577-83. doi: 10.1016/s0003-9993(99)90333-7.
- Background: PubMed 10498351Taylor PN, Burridge JH, Dunkerley AL, Lamb A, Wood DE, Norton JA, Swain ID. Patients' perceptions of the Odstock Dropped Foot Stimulator (ODFS). Clin Rehabil. 1999 Oct;13(5):439-46. doi: 10.1191/026921599677086409.
- BackgroundTaylor P, Burridge J. Functional Electrical Stimulation - the Odstock Dropped Foot Stimulator. In: Sassoon R, ed. Understanding Stroke: Pardoe Blacker Publishing Ltd, 2002:72-78.
- BackgroundTaylor P. The use of electrical stimulation for correction of dropped foot in subjects with upper motor neuron lesions. Advances in Clinical Neurosciences and Rehabilitation 2002; 2:16-18.
- Background: PubMed 9596245Chae J, Bethoux F, Bohine T, Dobos L, Davis T, Friedl A. Neuromuscular stimulation for upper extremity motor and functional recovery in acute hemiplegia. Stroke. 1998 May;29(5):975-9. doi: 10.1161/01.str.29.5.975.
- Background: PubMed 9596400Francisco G, Chae J, Chawla H, Kirshblum S, Zorowitz R, Lewis G, Pang S. Electromyogram-triggered neuromuscular stimulation for improving the arm function of acute stroke survivors: a randomized pilot study. Arch Phys Med Rehabil. 1998 May;79(5):570-5. doi: 10.1016/s0003-9993(98)90074-0.
- BackgroundMann GE, Wright PA, Swain ID. Training effects of electrical stimulation and the conventional ankle foot orthosis in the correction of drop foot following stroke., 1st Annual Conference of FESnet, 2002.
- BackgroundTaylor P, Mann G, Swain I. Does prior use of an Ankle Foot Orthosis (AFO) effect the response to use of the Odstock Dropped Foot Stimulator?, Institute of Physics and Engineering in Medicine (IPEM) Annual Scientific Meeting, Bath, U.K., September 15-17, 2003:89-90.
- Cleveland FES CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
John Chae, MD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Odstock Dropped-Foot Stimulator (ODFS) and Traditional Physical Therapy Treatment in people with Stroke and Hemiplegia, run by MetroHealth 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 10 inclusion and 20 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 1 Jun 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2018). 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?
Fugl-Meyer Motor Assessment (FMA) (time frame: Weeks 0, 12, 24, 36). 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 NCT00148343, which also lists 33 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 1 Jun 2018.