Upper Extremity SpasticityBotox + FESNCT00462449
Efficacy of Functional Electrical Stimulation (FES) in Persons Receiving Botulinum Neurotoxin for Upper Extremity Spasticity
A study testing Functional Electrical Stimulation (FES) through the Ness H200 in people with Upper Extremity Spasticity and Stroke, run by University of Pittsburgh at 1 site in United States.
Trial summary
FES is a form of treatment with a device to aid movement in people who have had damage to their brain or spinal cord. Small electrical impulses are used to excite/stimulate the nerves that supply paralyzed muscles. This activates those muscles, enabling them to produce basic but useful movement. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Upper Extremity Spasticity, Stroke, Acquired Brain Injury
- What is being tested?
- Functional Electrical Stimulation (FES) through the Ness H200
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jan 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum 6 months post injury/insult with unilateral upper limb spasticity of the elbow, wrist and/or finger flexors.
- Preinjection Modified Ashworth scores > 2 in at least one of the following areas: elbow, wrist, or finger flexors.
- Subjects must meet criteria for CMA Hand Impairment Scale Stage 2 and be able to complete Task 3 (thumb to index finger) of the CMA Hand Impairment Scale Stage 3, or demonstrate 50% gross grasp to be included.
- Botulinum toxin A (Botox®) stable patients (have received at least two prior doses of the agent with first dose occurring at least 6 months prior to study enrollment).
- Able to answer reliably to yes/no questions.
- Able to follow reliably 1-step instructions.
- Written informed consent.
- Females enrolled in this study who are of childbearing age will be required to use adequate measures of birth control for the entire study period. Those who do not agree will be excluded.
Who cannot join
- Uncontrolled, clinically significant medical condition other than the condition under evaluation.
- Severe, fixed joint contracture in the affected arm. Patients with mild contracture that does not significantly impact function will be included based upon the assessment of the PI.
- Known allergy or sensitivity to any of the components in the study medication.
- Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
- Treatment with botulinum toxin of any serotype for any reason in less than 3 months prior to initial date of injection for the study.
Show all 13Show fewer
- Any medical condition that may put the subject at increased risk with exposure to botulinum toxin type A including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.
- Evidence of recent alcohol or drug abuse.
- Infection or skin disorder at an anticipated injection and/or electrical stimulation sites.
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- Use of aminoglycoside antibiotics, curare like agents, or other agents that might interfere with neuromuscular function.
- Individuals with a cardiac pacemaker, a defibrillator, or baclofen pump.
- Individuals with an unhealed or healing fracture or dislocation in the arm to be evaluated.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Single Blind, Randomized Study to Determine the Safety and the Efficacy of Using Functional Electrical Stimulation (FES) and Repetitive Task Practice vs. Repetitive Task Practice Alone in Persons Receiving Botulinum Neurotoxin Type A Injections for Upper Extremity Spasticity
FES is a form of treatment with a device to aid movement in people who have had damage to their brain or spinal cord. Small electrical impulses are used to excite/stimulate the nerves that supply paralyzed muscles. This activates those muscles, enabling them to produce basic but useful movement. Self-adhesive patches (electrodes) are placed on the skin close to the nerve that supplies the muscle and are connected by wires to a stimulator that produces the impulses. In this way, FES is used to correct the muscle weakness that is caused by injury to the brain or spinal cord.
Repetitive task practice is an "activity-based" therapy program that has been shown to enhance the recovery of hand and arm functions after stroke. This therapy consists of a set of training activities that are designed by a qualified therapist specific to your functional abilities that are to be performed with the impaired hand. These activities are designed to stimulate functional improvement with repetitive practice.
Spasticity is a nervous system disorder where certain muscles are continuously contracted. Botox injections are commonly used to help to reduce spasticity in areas of the body with increased muscle tone. This research is designed to look at any additional benefit that may occur when Botox injections are combined with specific occupational therapy exercises and with a device that uses functional electrical stimulation (FES) to help improve muscle function after stroke.
Read the detailed description
This is a single-blinded, randomized controlled trial examining the effect of repetitive task practice (RTP) and functional electrical stimulation (FES) in individuals who receive routine clinical Botox ® injections for upper extremity spasticity. Botox® injections in combination with repetitive task practice (RTP) is used routinely to manage upper limb spasticity after stroke or acquired brain injury. RTP is an activity-based rehabilitation program that has been shown effective in promoting motor recovery (Wolf et al., 2002), but it requires a sufficient level of baseline motor function. Since FES enhances motor function, we hypothesize that an FES-assisted RTP intervention will provide greater improvement in hand function than RTP alone in patients receiving Botox ® injections.
The primary outcome will be upper extremity use during activities of daily living assessed observationally by the motor activities log (MAL-O). Secondary outcomes will be 1) dexterous hand function as measured by the action research arm test (ARAT); 2) client's perception of self-performance in activities of daily living assessed with the (MAL - Self Report); 3) global upper extremity impairment assessed by the Chedoke-McMaster Assessment (CMA); and 4) clinical spasticity assessed by the Modified Ashworth Scale (MAS).
The primary endpoint will be 6 weeks post-injection. Outcomes will also be assessed at a secondary endpoint, 12 weeks post-injection, to determine the persistence of treatment effects.
- Conditions
- Upper Extremity Spasticity, Stroke, Acquired Brain Injury
- Being tested
- Functional Electrical Stimulation (FES) through the Ness H200
- Keywords
- Botulinum Toxin, Ness H200, Functional Electrical Stimulation, Repetitive Task Practice
- Medical subject headings
- Stroke, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical Stimulation (FES) through the Ness H200Device
Also called NESS H200™ Product Specification
Specialized exercises will be presented to the participants in this group. They will be instructed on how to attach and complete this exercise program utilizing the FES device.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Individuals randomized into this group will only receive specialized therapy associated with this population. |
| 2 | Experimental | In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device. Receives: Device: Functional Electrical Stimulation (FES) through the Ness H200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Arm Function Based on Motor Activities Log (MAL-O)
upper extremity function during activities of daily living based on observer ratings. Scale runs 0 (not used) to 5 (normal function). No subscales used.
Measured: 12 weeks
Secondary outcomes (2)
Change From Baseline in Dexterous Hand Function as Measured by the Action Research Arm Test (ARAT)
Dextrous hand function measurement. Scale ranges from 0 (no dextrous arm function) to 57 (normal function)
Measured: 12 weeks
Change From Baseline in Self-performance in Activities of Daily Living Assessed With the (MAL - Self Report)
upper extremity function during activities of daily living as reported by the patient. Scale runs 0 (not used) to 5 (normal function). No subscales used.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startNov 2007
- Primary completionJan 2010
- Study completionJan 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 (27)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity SpasticityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Michael C. Munin, M.D., University of Pittsburgh
- Investigators
- Michael C. Munin, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462449
- Sponsor's protocol ID
- 0611012
- Acronym
- Botox + FES
- Status last verified
- Jun 2014
- First submitted
- 17 Apr 2007
- Last updated
- 20 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bajd T, Kralj A, Turk R, Benko H, Sega J. Use of functional electrical stimulation in the rehabilitation of patients with incomplete spinal cord injuries. J Biomed Eng. 1989 Mar;11(2):96-102. doi: 10.1016/0141-5425(89)90115-5.
PubMed 2784838Billian C, Gorman PH. Upper extremity applications of functional neuromuscular stimulation. Assist Technol. 1992;4(1):31-9. doi: 10.1080/10400435.1992.10132190.
PubMed 10171598Brashear A, Gordon MF, Elovic E, Kassicieh VD, Marciniak C, Do M, Lee CH, Jenkins S, Turkel C; Botox Post-Stroke Spasticity Study Group. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med. 2002 Aug 8;347(6):395-400. doi: 10.1056/NEJMoa011892.
PubMed 12167681Cauraugh 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 10835457Chae 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 9596245de Kroon JR, Ijzerman MJ, Chae J, Lankhorst GJ, Zilvold G. Relation between stimulation characteristics and clinical outcome in studies using electrical stimulation to improve motor control of the upper extremity in stroke. J Rehabil Med. 2005 Mar;37(2):65-74. doi: 10.1080/16501970410024190.
PubMed 15788340de Kroon JR, IJzerman MJ, Lankhorst GJ, Zilvold G. Electrical stimulation of the upper limb in stroke: stimulation of the extensors of the hand vs. alternate stimulation of flexors and extensors. Am J Phys Med Rehabil. 2004 Aug;83(8):592-600. doi: 10.1097/01.phm.0000133435.61610.55.
PubMed 15277960Duncan P, Studenski S, Richards L, Gollub S, Lai SM, Reker D, Perera S, Yates J, Koch V, Rigler S, Johnson D. Randomized clinical trial of therapeutic exercise in subacute stroke. Stroke. 2003 Sep;34(9):2173-80. doi: 10.1161/01.STR.0000083699.95351.F2. Epub 2003 Aug 14.
PubMed 12920254LIBERSON WT. Functional electrotherapy. Trans Am Soc Artif Intern Organs. 1962;8:373-7. doi: 10.1097/00002480-196204000-00075. No abstract available.
PubMed 14465050Mirbagheri MM, Ladouceur M, Barbeau H, Kearney RE. The effects of long-term FES-assisted walking on intrinsic and reflex dynamic stiffness in spastic spinal-cord-injured subjects. IEEE Trans Neural Syst Rehabil Eng. 2002 Dec;10(4):280-9. doi: 10.1109/TNSRE.2002.806838.
PubMed 12611365Nakayama H, Jorgensen HS, Pedersen PM, Raaschou HO, Olsen TS. Prevalence and risk factors of incontinence after stroke. The Copenhagen Stroke Study. Stroke. 1997 Jan;28(1):58-62. doi: 10.1161/01.str.28.1.58.
PubMed 8996489Olsen TS. Arm and leg paresis as outcome predictors in stroke rehabilitation. Stroke. 1990 Feb;21(2):247-51. doi: 10.1161/01.str.21.2.247.
PubMed 2305400Pandyan AD, Gregoric M, Barnes MP, Wood D, Van Wijck F, Burridge J, Hermens H, Johnson GR. Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil. 2005 Jan 7-21;27(1-2):2-6. doi: 10.1080/09638280400014576. No abstract available.
PubMed 15799140Powell 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 10390311Price CI, Pandyan AD. Electrical stimulation for preventing and treating post-stroke shoulder pain. Cochrane Database Syst Rev. 2000;2000(4):CD001698. doi: 10.1002/14651858.CD001698.
PubMed 11034725
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Blind, Randomized Study to Determine the Safety and the Efficacy of Using Functional Electrical Stimulation (FES) and Repetitive Task Practice vs. Repetitive Task Practice Alone in Persons Receiving Botulinum Neurotoxin Type A Injections for Upper Extremity Spasticity
- ClinicalTrials.gov ID
- NCT00462449
- Acronym / sponsor ID
- Botox + FES / 0611012
- Conditions
- Upper Extremity Spasticity, Stroke, Acquired Brain Injury
- Keywords
- Botulinum Toxin, Ness H200, Functional Electrical Stimulation, Repetitive Task Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Nov 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 19 Apr 2007 (estimated)
- Results
- Posted 20 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
FES is a form of treatment with a device to aid movement in people who have had damage to their brain or spinal cord. Small electrical impulses are used to excite/stimulate the nerves that supply paralyzed muscles. This activates those muscles, enabling them to produce basic but useful movement. Self-adhesive patches (electrodes) are placed on the skin close to the nerve that supplies the muscle and are connected by wires to a stimulator that produces the impulses. In this way, FES is used to correct the muscle weakness that is caused by injury to the brain or spinal cord.
Repetitive task practice is an "activity-based" therapy program that has been shown to enhance the recovery of hand and arm functions after stroke. This therapy consists of a set of training activities that are designed by a qualified therapist specific to your functional abilities that are to be performed with the impaired hand. These activities are designed to stimulate functional improvement with repetitive practice.
Spasticity is a nervous system disorder where certain muscles are continuously contracted. Botox injections are commonly used to help to reduce spasticity in areas of the body with increased muscle tone. This research is designed to look at any additional benefit that may occur when Botox injections are combined with specific occupational therapy exercises and with a device that uses functional electrical stimulation (FES) to help improve muscle function after stroke.
Detailed description
This is a single-blinded, randomized controlled trial examining the effect of repetitive task practice (RTP) and functional electrical stimulation (FES) in individuals who receive routine clinical Botox ® injections for upper extremity spasticity. Botox® injections in combination with repetitive task practice (RTP) is used routinely to manage upper limb spasticity after stroke or acquired brain injury. RTP is an activity-based rehabilitation program that has been shown effective in promoting motor recovery (Wolf et al., 2002), but it requires a sufficient level of baseline motor function. Since FES enhances motor function, we hypothesize that an FES-assisted RTP intervention will provide greater improvement in hand function than RTP alone in patients receiving Botox ® injections.
The primary outcome will be upper extremity use during activities of daily living assessed observationally by the motor activities log (MAL-O). Secondary outcomes will be 1) dexterous hand function as measured by the action research arm test (ARAT); 2) client's perception of self-performance in activities of daily living assessed with the (MAL - Self Report); 3) global upper extremity impairment assessed by the Chedoke-McMaster Assessment (CMA); and 4) clinical spasticity assessed by the Modified Ashworth Scale (MAS).
The primary endpoint will be 6 weeks post-injection. Outcomes will also be assessed at a secondary endpoint, 12 weeks post-injection, to determine the persistence of treatment effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Individuals randomized into this group will only receive specialized therapy associated with this population. |
| 2 | Experimental | Device: Functional Electrical Stimulation (FES) through the Ness H200In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Minimum 6 months post injury/insult with unilateral upper limb spasticity of the elbow, wrist and/or finger flexors.
- Preinjection Modified Ashworth scores > 2 in at least one of the following areas: elbow, wrist, or finger flexors.
- Subjects must meet criteria for CMA Hand Impairment Scale Stage 2 and be able to complete Task 3 (thumb to index finger) of the CMA Hand Impairment Scale Stage 3, or demonstrate 50% gross grasp to be included.
- Botulinum toxin A (Botox®) stable patients (have received at least two prior doses of the agent with first dose occurring at least 6 months prior to study enrollment).
- Able to answer reliably to yes/no questions.
Key exclusion criteria (13 listed)
- Uncontrolled, clinically significant medical condition other than the condition under evaluation.
- Severe, fixed joint contracture in the affected arm. Patients with mild contracture that does not significantly impact function will be included based upon the assessment of the PI.
- Known allergy or sensitivity to any of the components in the study medication.
- Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
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 |
|---|---|---|
| Functional Electrical Stimulation (FES) through the Ness H200Also: NESS H200™ Product SpecificationSpecialized exercises will be presented to the participants in this group. They will be instructed on how to attach and complete this exercise program utilizing the FES device. | Device | 2 |
Primary outcome
Change From Baseline in Arm Function Based on Motor Activities Log (MAL-O)
Time frame: 12 weeks
upper extremity function during activities of daily living based on observer ratings. Scale runs 0 (not used) to 5 (normal function). No subscales used.
2 secondary outcomes
Change From Baseline in Dexterous Hand Function as Measured by the Action Research Arm Test (ARAT)
Time frame: 12 weeks
Change From Baseline in Self-performance in Activities of Daily Living Assessed With the (MAL - Self Report)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2784838Bajd T, Kralj A, Turk R, Benko H, Sega J. Use of functional electrical stimulation in the rehabilitation of patients with incomplete spinal cord injuries. J Biomed Eng. 1989 Mar;11(2):96-102. doi: 10.1016/0141-5425(89)90115-5.
- Background: PubMed 10171598Billian C, Gorman PH. Upper extremity applications of functional neuromuscular stimulation. Assist Technol. 1992;4(1):31-9. doi: 10.1080/10400435.1992.10132190.
- Background: PubMed 12167681Brashear A, Gordon MF, Elovic E, Kassicieh VD, Marciniak C, Do M, Lee CH, Jenkins S, Turkel C; Botox Post-Stroke Spasticity Study Group. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med. 2002 Aug 8;347(6):395-400. doi: 10.1056/NEJMoa011892.
- 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 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 15788340de Kroon JR, Ijzerman MJ, Chae J, Lankhorst GJ, Zilvold G. Relation between stimulation characteristics and clinical outcome in studies using electrical stimulation to improve motor control of the upper extremity in stroke. J Rehabil Med. 2005 Mar;37(2):65-74. doi: 10.1080/16501970410024190.
- Background: PubMed 15277960de Kroon JR, IJzerman MJ, Lankhorst GJ, Zilvold G. Electrical stimulation of the upper limb in stroke: stimulation of the extensors of the hand vs. alternate stimulation of flexors and extensors. Am J Phys Med Rehabil. 2004 Aug;83(8):592-600. doi: 10.1097/01.phm.0000133435.61610.55.
- Background: PubMed 12920254Duncan P, Studenski S, Richards L, Gollub S, Lai SM, Reker D, Perera S, Yates J, Koch V, Rigler S, Johnson D. Randomized clinical trial of therapeutic exercise in subacute stroke. Stroke. 2003 Sep;34(9):2173-80. doi: 10.1161/01.STR.0000083699.95351.F2. Epub 2003 Aug 14.
- Background: PubMed 14465050LIBERSON WT. Functional electrotherapy. Trans Am Soc Artif Intern Organs. 1962;8:373-7. doi: 10.1097/00002480-196204000-00075. No abstract available.
- Background: PubMed 12611365Mirbagheri MM, Ladouceur M, Barbeau H, Kearney RE. The effects of long-term FES-assisted walking on intrinsic and reflex dynamic stiffness in spastic spinal-cord-injured subjects. IEEE Trans Neural Syst Rehabil Eng. 2002 Dec;10(4):280-9. doi: 10.1109/TNSRE.2002.806838.
- Background: PubMed 8996489Nakayama H, Jorgensen HS, Pedersen PM, Raaschou HO, Olsen TS. Prevalence and risk factors of incontinence after stroke. The Copenhagen Stroke Study. Stroke. 1997 Jan;28(1):58-62. doi: 10.1161/01.str.28.1.58.
- Background: PubMed 2305400Olsen TS. Arm and leg paresis as outcome predictors in stroke rehabilitation. Stroke. 1990 Feb;21(2):247-51. doi: 10.1161/01.str.21.2.247.
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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.
Michael C. Munin, M.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation (FES) through the Ness H200 in people with Upper Extremity Spasticity and Stroke, run by University of Pittsburgh 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 8 inclusion and 13 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 20 Jun 2014. 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 20 Jun 2014). 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 From Baseline in Arm Function Based on Motor Activities Log (MAL-O) (time frame: 12 weeks). 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 NCT00462449, which also lists 27 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 20 Jun 2014.