Stroke, AcuteNCT00142792
Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke
A study testing NMES device with EMG-triggered and Cyclic capabilities in people with Stroke, Acute and Stroke, run by MetroHealth Medical Center at 3 sites in United States.
Trial summary
Stroke is the leading cause of activity limitation among older adults in the United States. NeuroMuscular Electrical Stimulation (NMES) can assist stroke survivors in regaining motor ability and decreasing activity limitation caused by stroke. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Stroke, Acute, Stroke, Hemiparesis
- What is being tested?
- NMES device with EMG-triggered and Cyclic capabilities
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2005to Mar 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 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-89
- Evidence of clinical symptoms from a hemorrhagic or nonhemorrhagic stroke with all symptoms from previous stroke(s) completely resolved
- Medically stable
- Less than 6 months post-stroke
- Intact skin on the hemiparetic side
- Able to follow 3-stage commands
Show all 13Show fewer
- Able to recall 2/3 objects after 30 minutes
- Full passive ROM at the wrist and the thumb, index and long finger MCP joints on the affected side
- Presence of a detectable, volitionally-activated EMG signal from the paretic wrist or finger extensors (ECR or EDC)
- Affected wrist extensors ≤ 4 on MRC scale
- Score of ≤ 11/14 on Section C (hand) of UE portion of Fugl Meyer Assessment (FMA)
- Ability to tolerate NMES to the ECR and EDC for full wrist and finger extension
- Caregiver available to assist with the device every day (unless subject capable of using it independently
Who cannot join
- History of ventricular arrythmias or any other arrythmias (i.e. fast atrial fibrillation, ventricular tachycardia, or supraventricular tachycardia) with hemodynamic instability
- History of other upper motor neuron lesion
- Absent sensation of the affected limb
- Pregnancy
- History of more than one seizure per month during the last year (or, since the stroke if no seizures prior to stroke)
- Discharge to a skilled nursing facility or long-term care facility (EXCEPTION: Subjects may be d/c'd to the 6A SNF unit at MetroHealth Medical Center)
Show all 9Show fewer
- Uncompensated hemineglect
- Implanted stimulator (such as a pacemaker)
- Evidence of hand pain as defined by current metacarpophalangeal (MCP) joint pain upon palpation and/or wrist or MCP pain upon extension
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Edwin Shaw Rehab - Akron General Medical Center
Akron, Ohio, 44312
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
MetroHealth Medical Center
Cleveland, Ohio, 44109
About this study
Official title: Electrical Stimulation for Upper Limb Recovery in Stroke
Stroke is the leading cause of activity limitation among older adults in the United States. NeuroMuscular Electrical Stimulation (NMES) can assist stroke survivors in regaining motor ability and decreasing activity limitation caused by stroke. This study will research the effects of two types of NMES on reducing motor impairment and activity limitation.
Read the detailed description
Stroke is the leading cause of activity limitation among older adults in the United States. NeuroMuscular Electrical Stimulation (NMES) can be used by stroke survivors who do not have enough residual movement to take part in volitional active repetitive movement therapy and does not require expensive equipment or skilled personnel. Two types of NMES are available. The first is cyclic NMES, which electrically activates paretic muscles at a set duty cycle for a preset time period. (This study will employ both "traditional" cyclic stimulation and "sensory-only" stimulation, in which intensity is set at a level to be felt by the patient but insufficient to cause muscle contraction.)In cyclic NMES, the patient is a passive participant and does not assist the NMES by volitionally contracting the muscle during stimulation. The second type encompasses various forms of NMES in combination with biofeedback. For example, in "EMG-triggered" NMES, subjects are "rewarded" with stimulation in response to successful attempts to reach a pre-set level of EMG activity in the affected muscle. There is increased cognitive input and involvement on the part of the patient. The purpose of this study is to first demonstrate the effectiveness of these two types of surface stimulation on decreasing motor impairment and activity limitation; the study also seeks to assess the effect of adding cognitive input to NMES to reduce motor impairment and activity limitation.
Study subjects will be acute stroke survivors. They will participate for a total of eight months, beginning within the first six months after their stroke. Subjects will be randomly assigned to one of three treatment groups and will receive stimulation accordingly: 1) Cyclic stimulation; 2)Sensory-only stimulation; and 3)EMG-triggered stimulation. Members of each treatment group will be given an appropriate NMES device to use for two 40-minute treatment sessions per day, five times per week for eight weeks; for a total of 80 treatment sessions. Stimulation will be applied to ECR and EDC (wrist and finger extensors) on the affected arm. A treatment therapist will visit the patient at home on a weekly basis to monitor subject compliance and to provide feedback on device usage. The primary outcome measure will be the upper extremity portion of the Fugl-Meyer Motor Assessment (FMA), a measure of motor impairment. The modified Arm Motor Ability Test (mAMAT) is a hemiparetic arm-specific measure of activity limitation, and will serve as a secondary outcome measure.
In addition to the baseline visit on day of enrollment, subjects will complete these outcome measurements at the clinic on five other occasions: at mid-treatment (week 5); end of treatment (week 9); and for follow-up visits at one-, three- and six-months post-treatment.
- Conditions
- Stroke, Acute, Stroke, Hemiparesis
- Being tested
- NMES device with EMG-triggered and Cyclic capabilities
- Keywords
- stroke, recovery of function, functional electrical stimulation (FES)
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMES device with EMG-triggered and Cyclic capabilitiesDevice
Also called NeuroMove NM900 stimulator
All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
| Study group | Role | What they receive |
|---|---|---|
| A. Cyclic stim | Active comparator | * Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
* Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
* Uses NMES device with EMG-triggered and Cyclic capabilities Receives: Device: NMES device with EMG-triggered and Cyclic capabilities |
| B. Sensory stim | Active comparator | Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.
Uses NMES device with EMG-triggered and Cyclic capabilities Receives: Device: NMES device with EMG-triggered and Cyclic capabilities |
| C. EMG-Triggered | Active comparator | EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be "rewarded" with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.
Uses NMES device with EMG-triggered and Cyclic capabilities Receives: Device: NMES device with EMG-triggered and Cyclic capabilities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure
The FMA battery measures six dimensions of post-stroke impairment including upper and lower limb motor impairment, range of motion, pain, reflexes, and sensation. , "Each item (33 total) is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and summed to provide a score ranging from 0 to 66, where higher scores indicate better motor function The FMA was administered with the participant seated.
Measured: FMA will be administered on 6 occasions: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.
Secondary outcomes (1)
Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation
The AMAT assesses upper limb specific tasks and does not allow for compensation. The AMAT consists of 13 compound ADL tasks composed of 1 to 3 component tasks, with a total of 28 component tasks. Each task was rated on the functional ability ordinal scale from 0-5 and an average is calculated, so the final score remains 0-5, with higher scores indicating lesser activity limitation. Total range of reported data is between 0 and 5 because the average is reported. 0 refers to no function. 5 refers to normal function.
Measured: AMAT will be administered on 6 occasions as above: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startDec 2005
- Primary completionMar 2010
- Study completionMar 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 (12)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies 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
- 122 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
- NCT00142792
- Sponsor's protocol ID
- R01HD049777
- Other IDs
- R01HD049777
- Status last verified
- Mar 2018
- First submitted
- 31 Aug 2005
- Last updated
- 29 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Glanz M, Klawansky S, Stason W, Berkey C, Chalmers TC. Functional electrostimulation in poststroke rehabilitation: a meta-analysis of the randomized controlled trials. Arch Phys Med Rehabil. 1996 Jun;77(6):549-53. doi: 10.1016/s0003-9993(96)90293-2.
PubMed 8831470Chae 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 9596245Powell J, Pandyan AD, Granat M, Cameron M, Stott DJ. Electrical stimulation of wrist extensors in poststroke hemiplegia. Stroke. 1999 Jul;30(7):1384-9. doi: 10.1161/01.str.30.7.1384.
PubMed 10390311Francisco 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 9596400Cauraugh J, Light K, Kim S, Thigpen M, Behrman A. Chronic motor dysfunction after stroke: recovering wrist and finger extension by electromyography-triggered neuromuscular stimulation. Stroke. 2000 Jun;31(6):1360-4. doi: 10.1161/01.str.31.6.1360.
PubMed 10835457Cauraugh JH, Kim S. Two coupled motor recovery protocols are better than one: electromyogram-triggered neuromuscular stimulation and bilateral movements. Stroke. 2002 Jun;33(6):1589-94. doi: 10.1161/01.str.0000016926.77114.a6.
PubMed 12052996Sonde L, Gip C, Fernaeus SE, Nilsson CG, Viitanen M. Stimulation with low frequency (1.7 Hz) transcutaneous electric nerve stimulation (low-tens) increases motor function of the post-stroke paretic arm. Scand J Rehabil Med. 1998 Jun;30(2):95-9. doi: 10.1080/003655098444192.
PubMed 9606771Sonde L, Kalimo H, Fernaeus SE, Viitanen M. Low TENS treatment on post-stroke paretic arm: a three-year follow-up. Clin Rehabil. 2000 Feb;14(1):14-9. doi: 10.1191/026921500673534278.
PubMed 10688340Bowman BR, Baker LL, Waters RL. Positional feedback and electrical stimulation: an automated treatment for the hemiplegic wrist. Arch Phys Med Rehabil. 1979 Nov;60(11):497-502.
PubMed 508075Kraft GH, Fitts SS, Hammond MC. Techniques to improve function of the arm and hand in chronic hemiplegia. Arch Phys Med Rehabil. 1992 Mar;73(3):220-7.
PubMed 1543423Kimberley TJ, Lewis SM, Auerbach EJ, Dorsey LL, Lojovich JM, Carey JR. Electrical stimulation driving functional improvements and cortical changes in subjects with stroke. Exp Brain Res. 2004 Feb;154(4):450-60. doi: 10.1007/s00221-003-1695-y. Epub 2003 Nov 15.
PubMed 14618287Wilson RD, Page SJ, Delahanty M, Knutson JS, Gunzler DD, Sheffler LR, Chae J. Upper-Limb Recovery After Stroke: A Randomized Controlled Trial Comparing EMG-Triggered, Cyclic, and Sensory Electrical Stimulation. Neurorehabil Neural Repair. 2016 Nov;30(10):978-987. doi: 10.1177/1545968316650278. Epub 2016 May 24.
PubMed 27225977
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation for Upper Limb Recovery in Stroke
- ClinicalTrials.gov ID
- NCT00142792
- Acronym / sponsor ID
- R01HD049777
- Conditions
- Stroke, Acute, Stroke, Hemiparesis
- Keywords
- stroke, recovery of function, functional electrical stimulation (FES)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 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
- Dec 2005
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Posted 29 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is the leading cause of activity limitation among older adults in the United States. NeuroMuscular Electrical Stimulation (NMES) can assist stroke survivors in regaining motor ability and decreasing activity limitation caused by stroke. This study will research the effects of two types of NMES on reducing motor impairment and activity limitation.
Detailed description
Stroke is the leading cause of activity limitation among older adults in the United States. NeuroMuscular Electrical Stimulation (NMES) can be used by stroke survivors who do not have enough residual movement to take part in volitional active repetitive movement therapy and does not require expensive equipment or skilled personnel. Two types of NMES are available. The first is cyclic NMES, which electrically activates paretic muscles at a set duty cycle for a preset time period. (This study will employ both "traditional" cyclic stimulation and "sensory-only" stimulation, in which intensity is set at a level to be felt by the patient but insufficient to cause muscle contraction.)In cyclic NMES, the patient is a passive participant and does not assist the NMES by volitionally contracting the muscle during stimulation. The second type encompasses various forms of NMES in combination with biofeedback. For example, in "EMG-triggered" NMES, subjects are "rewarded" with stimulation in response to successful attempts to reach a pre-set level of EMG activity in the affected muscle. There is increased cognitive input and involvement on the part of the patient. The purpose of this study is to first demonstrate the effectiveness of these two types of surface stimulation on decreasing motor impairment and activity limitation; the study also seeks to assess the effect of adding cognitive input to NMES to reduce motor impairment and activity limitation.
Study subjects will be acute stroke survivors. They will participate for a total of eight months, beginning within the first six months after their stroke. Subjects will be randomly assigned to one of three treatment groups and will receive stimulation accordingly: 1) Cyclic stimulation; 2)Sensory-only stimulation; and 3)EMG-triggered stimulation. Members of each treatment group will be given an appropriate NMES device to use for two 40-minute treatment sessions per day, five times per week for eight weeks; for a total of 80 treatment sessions. Stimulation will be applied to ECR and EDC (wrist and finger extensors) on the affected arm. A treatment therapist will visit the patient at home on a weekly basis to monitor subject compliance and to provide feedback on device usage. The primary outcome measure will be the upper extremity portion of the Fugl-Meyer Motor Assessment (FMA), a measure of motor impairment. The modified Arm Motor Ability Test (mAMAT) is a hemiparetic arm-specific measure of activity limitation, and will serve as a secondary outcome measure.
In addition to the baseline visit on day of enrollment, subjects will complete these outcome measurements at the clinic on five other occasions: at mid-treatment (week 5); end of treatment (week 9); and for follow-up visits at one-, three- and six-months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A. Cyclic stim | Active comparator | Device: NMES device with EMG-triggered and Cyclic capabilities* Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject. * Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation * Uses NMES device with EMG-triggered and Cyclic capabilities |
| B. Sensory stim | Active comparator | Device: NMES device with EMG-triggered and Cyclic capabilitiesSensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction. Uses NMES device with EMG-triggered and Cyclic capabilities |
| C. EMG-Triggered | Active comparator | Device: NMES device with EMG-triggered and Cyclic capabilitiesEMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be "rewarded" with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level. Uses NMES device with EMG-triggered and Cyclic capabilities |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 21-89
- Evidence of clinical symptoms from a hemorrhagic or nonhemorrhagic stroke with all symptoms from previous stroke(s) completely resolved
- Medically stable
- Less than 6 months post-stroke
- Intact skin on the hemiparetic side
Key exclusion criteria (9 listed)
- History of ventricular arrythmias or any other arrythmias (i.e. fast atrial fibrillation, ventricular tachycardia, or supraventricular tachycardia) with hemodynamic instability
- History of other upper motor neuron lesion
- Absent sensation of the affected limb
- Pregnancy
- History of more than one seizure per month during the last year (or, since the stroke if no seizures prior to stroke)
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 |
|---|---|---|
| NMES device with EMG-triggered and Cyclic capabilitiesAlso: NeuroMove NM900 stimulatorAll groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles. | Device | A. Cyclic stim, B. Sensory stim, C. EMG-Triggered |
Primary outcome
Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure
Time frame: FMA will be administered on 6 occasions: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.
The FMA battery measures six dimensions of post-stroke impairment including upper and lower limb motor impairment, range of motion, pain, reflexes, and sensation. , "Each item (33 total) is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and summed to provide a score ranging from 0 to 66, where higher scores indicate better motor function The FMA was administered with the participant seated.
1 secondary outcome
Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation
Time frame: AMAT will be administered on 6 occasions as above: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8831470Glanz M, Klawansky S, Stason W, Berkey C, Chalmers TC. Functional electrostimulation in poststroke rehabilitation: a meta-analysis of the randomized controlled trials. Arch Phys Med Rehabil. 1996 Jun;77(6):549-53. doi: 10.1016/s0003-9993(96)90293-2.
- 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 10390311Powell J, Pandyan AD, Granat M, Cameron M, Stott DJ. Electrical stimulation of wrist extensors in poststroke hemiplegia. Stroke. 1999 Jul;30(7):1384-9. doi: 10.1161/01.str.30.7.1384.
- 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.
- Background: PubMed 10835457Cauraugh J, Light K, Kim S, Thigpen M, Behrman A. Chronic motor dysfunction after stroke: recovering wrist and finger extension by electromyography-triggered neuromuscular stimulation. Stroke. 2000 Jun;31(6):1360-4. doi: 10.1161/01.str.31.6.1360.
- Background: PubMed 12052996Cauraugh JH, Kim S. Two coupled motor recovery protocols are better than one: electromyogram-triggered neuromuscular stimulation and bilateral movements. Stroke. 2002 Jun;33(6):1589-94. doi: 10.1161/01.str.0000016926.77114.a6.
- Background: PubMed 9606771Sonde L, Gip C, Fernaeus SE, Nilsson CG, Viitanen M. Stimulation with low frequency (1.7 Hz) transcutaneous electric nerve stimulation (low-tens) increases motor function of the post-stroke paretic arm. Scand J Rehabil Med. 1998 Jun;30(2):95-9. doi: 10.1080/003655098444192.
- Background: PubMed 10688340Sonde L, Kalimo H, Fernaeus SE, Viitanen M. Low TENS treatment on post-stroke paretic arm: a three-year follow-up. Clin Rehabil. 2000 Feb;14(1):14-9. doi: 10.1191/026921500673534278.
- Background: PubMed 508075Bowman BR, Baker LL, Waters RL. Positional feedback and electrical stimulation: an automated treatment for the hemiplegic wrist. Arch Phys Med Rehabil. 1979 Nov;60(11):497-502.
- Background: PubMed 1543423Kraft GH, Fitts SS, Hammond MC. Techniques to improve function of the arm and hand in chronic hemiplegia. Arch Phys Med Rehabil. 1992 Mar;73(3):220-7.
- Background: PubMed 14618287Kimberley TJ, Lewis SM, Auerbach EJ, Dorsey LL, Lojovich JM, Carey JR. Electrical stimulation driving functional improvements and cortical changes in subjects with stroke. Exp Brain Res. 2004 Feb;154(4):450-60. doi: 10.1007/s00221-003-1695-y. Epub 2003 Nov 15.
- Derived from this study: PubMed 27225977Wilson RD, Page SJ, Delahanty M, Knutson JS, Gunzler DD, Sheffler LR, Chae J. Upper-Limb Recovery After Stroke: A Randomized Controlled Trial Comparing EMG-Triggered, Cyclic, and Sensory Electrical Stimulation. Neurorehabil Neural Repair. 2016 Nov;30(10):978-987. doi: 10.1177/1545968316650278. Epub 2016 May 24.
- Cleveland FES CenterLink provided by the sponsor.
- Neuromotor Recovery \& Rehabilitation Laboratory, Cincinnati, OhioLink 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES device with EMG-triggered and Cyclic capabilities in people with Stroke, Acute and Stroke, run by MetroHealth Medical Center at 3 sites 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 13 inclusion and 9 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 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 29 Mar 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) - Motor Impairment Measure (time frame: FMA will be administered on 6 occasions: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00142792, which also lists 12 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 29 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.