StrokeNCT01029912
Electrical Stimulation for Recovery of Ankle Dorsiflexion in Chronic Stroke Survivors
A study testing Electrical stimulator in people with Stroke and Hemiparesis, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
Ankle dorsiflexor weakness (paresis) is one of the most frequently persisting consequences of stroke. The purpose of this exploratory study is to compare two different treatments -- Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) and Cyclic Neuromuscular Electrical Stimulation (cNMES) -- for… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke, Hemiparesis, Lower Extremity Paresis
- What is being tested?
- Electrical stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Aug 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 to 80 years
- >6 months from a first clinical non-hemorrhagic or hemorrhagic stroke
- Medically stable
- Unilateral lower extremity hemiparesis
- Ankle dorsiflexor strength of ≤4/5 on the Medical Research Council (MRC) scale, while seated
- Able to ambulate 16 feet (5 meters) continuously with minimal assistance or less, without the use of an ankle-foot orthosis (AFO).
Show all 14Show fewer
- AFO is clinically indicated (footdrop during ambulation or inefficient gait patterns)
- Neuromuscular electrical stimulation (NMES) of the paretic ankle dorsiflexors produces ankle dorsiflexion to neutral without pain.
- Full voluntary dorsiflexion of the contralateral ankle
- Skin intact on hemiparetic lower extremity
- Able to don the NMES system or caregiver available to assist with device if needed.
- Able to hear and respond to stimulator auditory cues
- Able to follow 3-stage commands
- Able to recall 2 of 3 items after 30 minutes
Who cannot join
- Brainstem stroke
- Severely impaired cognition and communication
- History of peroneal nerve injury
- History of Parkinson's, spinal cord injury, traumatic brain injury, or multiple sclerosis
- Uncontrolled seizure disorder
- Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
Show all 14Show fewer
- Edema of the affected lower extremity
- Absent sensation of lower leg and foot
- Evidence of deep venous thrombosis or thromboembolism
- History of cardiac arrhythmias with hemodynamic instability
- Cardiac pacemaker or other implanted electronic system
- Botulinum toxin injections to any lower extremity muscle in the last 3 months
- Pregnancy
- Currently receiving Physical Therapy for the lower extremity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contralaterally Controlled NMES in Chronic Ankle Dorsiflexor Paresis After Stroke
Ankle dorsiflexor weakness (paresis) is one of the most frequently persisting consequences of stroke. The purpose of this exploratory study is to compare two different treatments -- Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) and Cyclic Neuromuscular Electrical Stimulation (cNMES) -- for improved recovery of ankle movement and better walking after stroke.
Read the detailed description
Ankle dorsiflexor weakness results in inefficient and unstable gait. While routine physical therapy is beneficial, for many individuals it remains limited in its effectiveness, and consequently many stroke survivors have difficulty walking safely or remain non-ambulatory. Ankle-foot-orthoses (AFOs) are often prescribed to provide ankle stability, but because they limit ankle mobility they may actually inhibit recovery of dorsiflexion. Advanced rehabilitation techniques that emphasize active, repetitive, goal-oriented movement of the impaired limb have produced measurable functional improvements, yet a significant degree of lower extremity disability often remains. In addition, some of these emerging therapies are difficult to administer and are applicable only to patients who retain at least some degree of ambulation. Thus, there is a need for alternative treatments.
This is an exploratory study of an innovative neuromuscular electrical stimulation (NMES) treatment for restoring lower extremity motor control following stroke. We will investigate whether stroke survivors with chronic footdrop recover voluntary ankle dorsiflexion after a novel treatment of NMES. Surface electrodes will deliver stimulation to dorsiflex the ankle with an intensity that is proportional to the amount of dorsiflexion of the other unimpaired ankle. Thus, voluntary dorsiflexion of the unaffected ankle produces stimulated dorsiflexion of the affected ankle. We refer to this stimulation paradigm as Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES). In contrast to existing peroneal nerve stimulators, CCNMES is not intended to be used to assist ambulation; rather it is intended as solely a motor retraining paradigm that may reduce lower extremity impairment and improve ambulation. The primary objective of the proposed study is to obtain pilot data so that an estimate can be made of the efficacy of CCNMES in reducing lower extremity impairment and improving ambulation.
Twenty-six chronic stroke survivors (>6 months post-stroke) will be randomized to either CCNMES or cyclic NMES, an intervention that provides electrical stimulation of the ankle dorsiflexors, but with preprogrammed timing and intensity. For both groups, the treatment will last 6 weeks. Assessments of ankle impairment and ambulation will be made at baseline and at end of treatment.
This study is the first randomized controlled trial of CCNMES for restoring ankle dorsiflexion in patients with chronic hemiplegia.
- Conditions
- Stroke, Hemiparesis, Lower Extremity Paresis
- Being tested
- Electrical stimulator
- Keywords
- Stroke, Hemiplegia, Footdrop, Electrical Stimulation, Motor Relearning, Neuroplasticity
- Medical subject headings
- Stroke, Paresis, Hemiplegia, Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulatorDevice
6-week intervention
15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.
Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device.
| Study group | Role | What they receive |
|---|---|---|
| CCNMES | Experimental | Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) Electrical Stimulator Receives: Device: Electrical stimulator |
| Cyclic NMES | Active comparator | Cyclic Neuromuscular Electrical Stimulation (NMES) Electrical Stimulator Receives: Device: Electrical stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower Extremity Fugl-Meyer Score at End of Treatment
The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0.
Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged.
Measured: 2 timepoints: Prior to treatment, and End of treatment at 6 weeks.
Change in Gait Velocity (cm/Sec) at End of Treatment
Gait velocity was assessed using a motion capture and analysis system which collected spatio-temporal data as the participant walked 5-meters 10 times at a self-selected comfortable speed within the field of view of the motion capture system. A higher gait velocity is considered to be a better outcome. For each individual, the gait velocity prior to treatment was subtracted from the gait velocity at end of the 6-week treatment. Then for each treatment group, these change values were averaged.
Measured: 2 timepoints: Prior to treatment, and End of treatment at 6 weeks.
Change in Time (Sec) to Complete the Modified Emory Functional Ambulation Profile (MEFAP).
The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time.
Lower times are considered to be a better outcome.
For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged.
Measured: 2 timepoints: Prior to treatment, and End of treatment at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2011
- Study completionAug 2011
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 (8)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
- 26 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, Jayme Knutson, MetroHealth Medical Center
- Investigators
- Jayme S. Knutson, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029912
- Sponsor's protocol ID
- R21HD061593
- Other IDs
- R21HD061593
- Status last verified
- Nov 2017
- First submitted
- 9 Dec 2009
- Last updated
- 7 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Nudo RJ, Wise BM, SiFuentes F, Milliken GW. Neural substrates for the effects of rehabilitative training on motor recovery after ischemic infarct. Science. 1996 Jun 21;272(5269):1791-4. doi: 10.1126/science.272.5269.1791.
PubMed 8650578Luft AR, McCombe-Waller S, Whitall J, Forrester LW, Macko R, Sorkin JD, Schulz JB, Goldberg AP, Hanley DF. Repetitive bilateral arm training and motor cortex activation in chronic stroke: a randomized controlled trial. JAMA. 2004 Oct 20;292(15):1853-61. doi: 10.1001/jama.292.15.1853.
PubMed 15494583Robbins SM, Houghton PE, Woodbury MG, Brown JL. The therapeutic effect of functional and transcutaneous electric stimulation on improving gait speed in stroke patients: a meta-analysis. Arch Phys Med Rehabil. 2006 Jun;87(6):853-9. doi: 10.1016/j.apmr.2006.02.026.
PubMed 16731222Rushton DN. Functional electrical stimulation and rehabilitation--an hypothesis. Med Eng Phys. 2003 Jan;25(1):75-8. doi: 10.1016/s1350-4533(02)00040-1.
PubMed 12485788Khaslavskaia S, Sinkjaer T. Motor cortex excitability following repetitive electrical stimulation of the common peroneal nerve depends on the voluntary drive. Exp Brain Res. 2005 May;162(4):497-502. doi: 10.1007/s00221-004-2153-1. Epub 2005 Feb 9.
PubMed 15702321Knutson JS, Harley MY, Hisel TZ, Chae J. Improving hand function in stroke survivors: a pilot study of contralaterally controlled functional electric stimulation in chronic hemiplegia. Arch Phys Med Rehabil. 2007 Apr;88(4):513-20. doi: 10.1016/j.apmr.2007.01.003.
PubMed 17398254Knutson JS, Hisel TZ, Harley MY, Chae J. A novel functional electrical stimulation treatment for recovery of hand function in hemiplegia: 12-week pilot study. Neurorehabil Neural Repair. 2009 Jan;23(1):17-25. doi: 10.1177/1545968308317577. Epub 2008 Sep 23.
PubMed 18812432Sheffler LR, Hennessey MT, Naples GG, Chae J. Peroneal nerve stimulation versus an ankle foot orthosis for correction of footdrop in stroke: impact on functional ambulation. Neurorehabil Neural Repair. 2006 Sep;20(3):355-60. doi: 10.1177/1545968306287925.
PubMed 16885421
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contralaterally Controlled NMES in Chronic Ankle Dorsiflexor Paresis After Stroke
- ClinicalTrials.gov ID
- NCT01029912
- Acronym / sponsor ID
- R21HD061593
- Conditions
- Stroke, Hemiparesis, Lower Extremity Paresis
- Keywords
- Stroke, Hemiplegia, Footdrop, Electrical Stimulation, Motor Relearning, Neuroplasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 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
- Nov 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 10 Dec 2009 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ankle dorsiflexor weakness (paresis) is one of the most frequently persisting consequences of stroke. The purpose of this exploratory study is to compare two different treatments -- Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) and Cyclic Neuromuscular Electrical Stimulation (cNMES) -- for improved recovery of ankle movement and better walking after stroke.
Detailed description
Ankle dorsiflexor weakness results in inefficient and unstable gait. While routine physical therapy is beneficial, for many individuals it remains limited in its effectiveness, and consequently many stroke survivors have difficulty walking safely or remain non-ambulatory. Ankle-foot-orthoses (AFOs) are often prescribed to provide ankle stability, but because they limit ankle mobility they may actually inhibit recovery of dorsiflexion. Advanced rehabilitation techniques that emphasize active, repetitive, goal-oriented movement of the impaired limb have produced measurable functional improvements, yet a significant degree of lower extremity disability often remains. In addition, some of these emerging therapies are difficult to administer and are applicable only to patients who retain at least some degree of ambulation. Thus, there is a need for alternative treatments.
This is an exploratory study of an innovative neuromuscular electrical stimulation (NMES) treatment for restoring lower extremity motor control following stroke. We will investigate whether stroke survivors with chronic footdrop recover voluntary ankle dorsiflexion after a novel treatment of NMES. Surface electrodes will deliver stimulation to dorsiflex the ankle with an intensity that is proportional to the amount of dorsiflexion of the other unimpaired ankle. Thus, voluntary dorsiflexion of the unaffected ankle produces stimulated dorsiflexion of the affected ankle. We refer to this stimulation paradigm as Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES). In contrast to existing peroneal nerve stimulators, CCNMES is not intended to be used to assist ambulation; rather it is intended as solely a motor retraining paradigm that may reduce lower extremity impairment and improve ambulation. The primary objective of the proposed study is to obtain pilot data so that an estimate can be made of the efficacy of CCNMES in reducing lower extremity impairment and improving ambulation.
Twenty-six chronic stroke survivors (>6 months post-stroke) will be randomized to either CCNMES or cyclic NMES, an intervention that provides electrical stimulation of the ankle dorsiflexors, but with preprogrammed timing and intensity. For both groups, the treatment will last 6 weeks. Assessments of ankle impairment and ambulation will be made at baseline and at end of treatment.
This study is the first randomized controlled trial of CCNMES for restoring ankle dorsiflexion in patients with chronic hemiplegia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCNMES | Experimental | Device: Electrical stimulatorContralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) Electrical Stimulator |
| Cyclic NMES | Active comparator | Device: Electrical stimulatorCyclic Neuromuscular Electrical Stimulation (NMES) Electrical Stimulator |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 21 to 80 years
- >6 months from a first clinical non-hemorrhagic or hemorrhagic stroke
- Medically stable
- Unilateral lower extremity hemiparesis
- Ankle dorsiflexor strength of ≤4/5 on the Medical Research Council (MRC) scale, while seated
Key exclusion criteria (14 listed)
- Brainstem stroke
- Severely impaired cognition and communication
- History of peroneal nerve injury
- History of Parkinson's, spinal cord injury, traumatic brain injury, or multiple sclerosis
- Uncontrolled seizure disorder
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 |
|---|---|---|
| Electrical stimulator6-week intervention 15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week. Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device. | Device | CCNMES, Cyclic NMES |
Primary outcome
Change in Lower Extremity Fugl-Meyer Score at End of Treatment
Time frame: 2 timepoints: Prior to treatment, and End of treatment at 6 weeks.
The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0. Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged.
Change in Gait Velocity (cm/Sec) at End of Treatment
Time frame: 2 timepoints: Prior to treatment, and End of treatment at 6 weeks.
Gait velocity was assessed using a motion capture and analysis system which collected spatio-temporal data as the participant walked 5-meters 10 times at a self-selected comfortable speed within the field of view of the motion capture system. A higher gait velocity is considered to be a better outcome. For each individual, the gait velocity prior to treatment was subtracted from the gait velocity at end of the 6-week treatment. Then for each treatment group, these change values were averaged.
Change in Time (Sec) to Complete the Modified Emory Functional Ambulation Profile (MEFAP).
Time frame: 2 timepoints: Prior to treatment, and End of treatment at 6 weeks.
The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time. Lower times are considered to be a better outcome. For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8650578Nudo RJ, Wise BM, SiFuentes F, Milliken GW. Neural substrates for the effects of rehabilitative training on motor recovery after ischemic infarct. Science. 1996 Jun 21;272(5269):1791-4. doi: 10.1126/science.272.5269.1791.
- Background: PubMed 15494583Luft AR, McCombe-Waller S, Whitall J, Forrester LW, Macko R, Sorkin JD, Schulz JB, Goldberg AP, Hanley DF. Repetitive bilateral arm training and motor cortex activation in chronic stroke: a randomized controlled trial. JAMA. 2004 Oct 20;292(15):1853-61. doi: 10.1001/jama.292.15.1853.
- Background: PubMed 16731222Robbins SM, Houghton PE, Woodbury MG, Brown JL. The therapeutic effect of functional and transcutaneous electric stimulation on improving gait speed in stroke patients: a meta-analysis. Arch Phys Med Rehabil. 2006 Jun;87(6):853-9. doi: 10.1016/j.apmr.2006.02.026.
- Background: PubMed 12485788Rushton DN. Functional electrical stimulation and rehabilitation--an hypothesis. Med Eng Phys. 2003 Jan;25(1):75-8. doi: 10.1016/s1350-4533(02)00040-1.
- Background: PubMed 15702321Khaslavskaia S, Sinkjaer T. Motor cortex excitability following repetitive electrical stimulation of the common peroneal nerve depends on the voluntary drive. Exp Brain Res. 2005 May;162(4):497-502. doi: 10.1007/s00221-004-2153-1. Epub 2005 Feb 9.
- Background: PubMed 17398254Knutson JS, Harley MY, Hisel TZ, Chae J. Improving hand function in stroke survivors: a pilot study of contralaterally controlled functional electric stimulation in chronic hemiplegia. Arch Phys Med Rehabil. 2007 Apr;88(4):513-20. doi: 10.1016/j.apmr.2007.01.003.
- Background: PubMed 18812432Knutson JS, Hisel TZ, Harley MY, Chae J. A novel functional electrical stimulation treatment for recovery of hand function in hemiplegia: 12-week pilot study. Neurorehabil Neural Repair. 2009 Jan;23(1):17-25. doi: 10.1177/1545968308317577. Epub 2008 Sep 23.
- Background: PubMed 16885421Sheffler LR, Hennessey MT, Naples GG, Chae J. Peroneal nerve stimulation versus an ankle foot orthosis for correction of footdrop in stroke: impact on functional ambulation. Neurorehabil Neural Repair. 2006 Sep;20(3):355-60. doi: 10.1177/1545968306287925.
- Cleveland Functional Electrical Stimulation 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.
Jayme S. Knutson, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulator in people with Stroke and Hemiparesis, 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 14 inclusion and 14 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 7 Dec 2017. 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 6 Nov 2017). 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?
Change in Lower Extremity Fugl-Meyer Score at End of Treatment (time frame: 2 timepoints: Prior to treatment, and End of treatment at 6 weeks.). The study lists 3 primary outcomes in all. 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 NCT01029912, which also lists 8 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 7 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.