StrokeNCT01688856
Contralaterally Controlled FES of Arm & Hand for Subacute Stroke Rehabilitation
A study testing Electrical Stimulator in people with Stroke and Hemiparesis, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
Impaired arm and hand function is one of the most disabling and most common consequences of stroke. The Investigators have developed Contralaterally Controlled Functional Electrical Stimulation (CCFES), an innovative neuromuscular electrical stimulation (NMES) treatment for improving the recovery of hand function… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke, Hemiparesis, Hemiplegia
- 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
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 31 Aug 2018
- 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 and ≤ 80
- ≤ 2 years of first clinical hemorrhagic or nonhemorrhagic stroke
- Skin intact on hemiparetic arm and hand
- Able to follow 3-stage commands
- Able to recall 2 of 3 items after 30 minutes
- Medically stable
Show all 17Show fewer
- Finger extensor paresis indicated by a score of ≤ 4 out of 5 on the manual muscle test (Medical Research Council scale)
- Adequate movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
- Caregiver available to assist with device daily - OR - able to independently don elbow cuff on unaffected arm
- Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
- Upper extremity hand section of Upper Extremity Fugl-Meyer (UEFM)≥ 1 AND ≤ 11/14
- Unable to simultaneously fully extend the elbow and fully open the hand toward tabletop object with arm unsupported (i.e. cannot voluntarily achieve the maximum passive range of motion (PROM) available)
- Functional PROM (minimal resistance) at shoulder, elbow, wrist, and hand simultaneously on affected side (i.e., there exists enough PROM to reach and acquire table-top objects).
- Able to hear and respond to stimulator cues
- While relaxed, surface NMES of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
- While relaxed with the forearm supported with a mobile arm support, surface NMES of elbow extensors (triceps) produces functional elbow extension without pain.
- Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment.
Who cannot join
- Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, Parkinson's Disease, Spinal Cord Injury, Traumatic Brain Injury, Multiple Sclerosis).
- Severely impaired cognition and communication
- Uncontrolled seizure disorder
- History of cardiac arrhythmias with hemodynamic instability
- Cardiac pacemaker or other implanted electronic device
- Pregnant
Show all 11Show fewer
- IM Botox injections in any UE muscle in the last 3 months
- Insensate arm, forearm, or hand
- Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
- Severe shoulder or hand pain
- Severe depression on Beck Depression Inventory (BDI) (score>=13 on BDI-fast screen)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Contralaterally Controlled FES for Acute Upper Limb Hemiplegia
Impaired arm and hand function is one of the most disabling and most common consequences of stroke. The Investigators have developed Contralaterally Controlled Functional Electrical Stimulation (CCFES), an innovative neuromuscular electrical stimulation (NMES) treatment for improving the recovery of hand function after stroke. The purpose of this study is to maximize the treatment effect of CCFES by adding stimulated elbow extension. The specific aims and hypotheses are as follows:
AIM 1: Estimate the effect of Arm+Hand CCFES on upper limb motor impairment and activity limitation.
Read more
Hypothesis 1: Stroke survivors treated with Arm+Hand CCFES have better outcomes on upper limb impairment and activity limitation measures than those treated with dose-matched Arm+Hand Cyclic NMES.
AIM 2: Estimate the effect of adding stimulated elbow extension to Hand CCFES.
Hypothesis 2: Stroke survivors treated with Arm+Hand CCFES will have greater reductions in upper limb impairment and activity limitation than those treated with Hand CCFES.
AIM 3: Describe the relationship between treatment effect and time elapsed between stroke onset and start of treatment.
Hypothesis 3: Patients who start Arm+Hand CCFES sooner after their stroke achieve better outcomes.
Read the detailed description
Loss of arm and hand function is a severely disabling condition that occurs in nearly 75% of the estimated 795,000 Americans who have a new or recurrent stroke each year [Roger 2011]. Upper limb impairment is often characterized by inability to extend the elbow and open the hand. The hope of regaining lost motor function after stroke has been fueled in recent years by the development of new rehabilitation therapies and devices that are aimed at promoting the brain's capacity to reorganize after injury in such a way that restores motor control of paretic limbs [Nudo 2001]. The Investigators' long-term objective is to develop stroke rehabilitation treatments for the hemiparetic upper limb that are optimized for effectiveness, applicability, and deployability.
The primary objective of this project is to estimate the effect of Arm+Hand Contralaterally Controlled Functional Electrical Stimulation (CCFES) in reducing upper limb motor impairment and activity limitation in subacute hemiplegia. CCFES is a treatment aimed at improving recovery of volitional motor function in stroke survivors [Knutson 2007; Knutson 2009; Knutson 2010]. Hand CCFES activates finger and thumb extensors with an intensity of electrical stimulation that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. The Hand CCFES system enables stroke patients to use their impaired hand to practice functional tasks in therapy sessions. CCFES incorporates the following features considered to be important to motor recovery and promoting neuroplasticity: synchronization of motor intent with motor execution of paretic hand opening [Rushton 2003; Kimberley 2004], bilateral symmetric movement [Luft 2004], intensive repetitive hand opening exercises [Lang 2009], and the practice of functional tasks [Nudo 2003]. In a pilot case series study of patients with chronic (> 6 months) post-stroke hemiplegia, all 6 participants experienced some reduction of upper limb motor impairment after several weeks of Hand CCFES [Knutson 2007; Knutson 2009]. The results of a Phase I randomized clinical trial (RCT) of Hand CCFES in 21 patients with subacute (≤ 6 months) hemiplegia suggested that Hand CCFES may be superior to cyclic neuromuscular electrical stimulation (NMES) in reducing upper extremity impairment and activity limitation [Knutson 2011].
In this study, added to the Hand CCFES treatment is stimulated elbow extension controlled by the contralateral elbow. This "next generation" CCFES treatment is called Arm+Hand CCFES. Arm+Hand CCFES therapy is intended to strengthen and improve the motor control of the proximal upper limb as well as the hand, to improve simultaneous reaching and hand opening, a functionally critical movement pattern that is often prevented by paresis and post-stroke flexor synergies. The secondary objective of this project is to evaluate the effect of adding elbow extensor stimulation to the Hand CCFES treatment.
Stroke survivors who are ≤ 2 years post-stroke with upper limb hemiplegia will be randomly assigned to receive 12 weeks of either Arm+Hand CCFES (stimulates elbow extension and hand opening), Hand CCFES (stimulates hand opening), or Arm+Hand Cyclic NMES (stimulates elbow extension and hand opening but with pre-set timing and intensity, i.e., not intention-driven), plus lab-based therapist-guided task practice. Upper limb impairment and activity limitation will be assessed at baseline, 6, 12, 20, 28, and 36 weeks.
This is the first randomized controlled trial of Arm+Hand CCFES in subacute upper extremity hemiplegia. Ultimately, the information learned in this study will serve to accelerate the development of a new treatment for reducing post-stroke disability.
- Conditions
- Stroke, Hemiparesis, Hemiplegia
- Being tested
- Electrical Stimulator
- Keywords
- hand, arm, stroke, hemiplegia, electrical stimulation, recovery, rehabilitation
- Medical subject headings
- Stroke, Paresis, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical StimulatorDevice
The 12-week treatment period consists of two components:
- Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. If Arm+Hand CCFES or Hand CCFES, the stimulator is used during task practice.
- Self-administered muscle stimulation exercise performed 10 sessions per week at home using the device. If Arm+Hand CCFES or Hand CCFES, each session is 46 minutes. If Arm+Hand Cyclic NMES, each session is 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Arm+Hand CCFES | Experimental | Uses an electrical stimulator that opens the paretic hand and extends the paretic elbow in response to and with an intensity proportional to movement of the contralateral arm and hand. The treatment dose will be approximately 2 hrs per day of self-administered stimulation-mediated exercise at home plus 70 min of functional task practice twice a week in the laboratory for 12 weeks. Receives: Device: Electrical Stimulator |
| Hand CCFES | Experimental | Uses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand. The treatment dose will be approximately 2 hrs per day of self-administered stimulation-mediated exercise at home plus 70 min of functional task practice twice a week in the laboratory for 12 weeks. Receives: Device: Electrical Stimulator |
| Arm+Hand Cyclic NMES | Active comparator | Uses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity. The treatment dose will be approximately 2 hrs per day of self-administered stimulation-mediated exercise at home plus 70 min of functional task practice twice a week in the laboratory for 12 weeks. Receives: Device: Electrical Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Box and Block Test (BBT) Score at 6 Months Post-Treatment
The BBT counts how many blocks a participant can pick up, move over a barrier, and release in 60 seconds. Higher scores mean a better outcome.
Measured: 2 timepoints: prior to treatment, 6 months post-treatment
Secondary outcomes (4)
Change in Reachable Workspace (RW) at 6 Months Post-Treatment
Reachable Workspace (RW) is the area (cm^2) traced out when reaching for a target moving in a circular path just outside the reach of the participant.
Measured: 2 timepoints: prior to treatment, 6 months post-treatment
Change in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-Treatment
The Upper Extremity Fugl-Meyer (UEFM) is an assessment of motor impairment of the upper limb in which the participant is asked to make specific movements of the arm, forearm, wrist, and hand. Each movement is scored 0, 1, or 2 and the subscores are summed.
Min=0; Max=66. Higher scores mean a better outcome.
Measured: 2 timepoints: prior to treatment, 6 months post-treatment
Change in Stroke Upper Limb Capacity Scale (SULCS) at 6 Months Post-Treatment
Stroke Upper Limb Capacity Scale (SULCS) is a 10-item test in which participants are given a score of 0 or 1 on their performance of tasks requiring varying degrees of upper limb capacity.
Min=0; Max=10. Higher scores mean a better outcome.
Measured: 2 timepoints: prior to treatment, 6 months post-treatment
Change in Arm Motor Abilities Test (AMAT) at 6 Months Post-Treatment
The Arm Motor Abilities Test (AMAT) is an assessment of the participant's ability to do 9 standardized upper limb tasks. Each task is composed of 1 to 3 component tasks, each of which is rated on an ordinal scale of 0 to 5. The final score is the average of all component task scores across all 9 compound tasks.
Min=0; Max=5. Higher scores mean a better outcome.
Measured: 2 timepoints: prior to treatment, 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 posted20 Sep 2012 (estimated)
- Study startJan 2013
- Primary completionAug 2018
- Study completion31 Aug 2018
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 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jayme Knutson, MetroHealth Medical Center
- Investigators
- Jayme S. Knutson, PhD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688856
- Sponsor's protocol ID
- IRB12-00493
- Other IDs
- R01HD068588
- Status last verified
- Jan 2020
- First submitted
- 17 Sep 2012
- Last updated
- 9 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nudo RJ, Plautz EJ, Frost SB. Role of adaptive plasticity in recovery of function after damage to motor cortex. Muscle Nerve. 2001 Aug;24(8):1000-19. doi: 10.1002/mus.1104.
PubMed 11439375Knutson 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 18812432Knutson JS, Chae J. A novel neuromuscular electrical stimulation treatment for recovery of ankle dorsiflexion in chronic hemiplegia: a case series pilot study. Am J Phys Med Rehabil. 2010 Aug;89(8):672-82. doi: 10.1097/PHM.0b013e3181e29bd7.
PubMed 20531158Kimberley 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 14618287Rushton 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 12485788Luft 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 15494583Lang CE, Macdonald JR, Reisman DS, Boyd L, Jacobson Kimberley T, Schindler-Ivens SM, Hornby TG, Ross SA, Scheets PL. Observation of amounts of movement practice provided during stroke rehabilitation. Arch Phys Med Rehabil. 2009 Oct;90(10):1692-8. doi: 10.1016/j.apmr.2009.04.005.
PubMed 19801058Nudo RJ. Adaptive plasticity in motor cortex: implications for rehabilitation after brain injury. J Rehabil Med. 2003 May;(41 Suppl):7-10. doi: 10.1080/16501960310010070.
PubMed 12817650Knutson JS, Harley MY, Hisel TZ, Hogan SD, Maloney MM, Chae J. Contralaterally controlled functional electrical stimulation for upper extremity hemiplegia: an early-phase randomized clinical trial in subacute stroke patients. Neurorehabil Neural Repair. 2012 Mar-Apr;26(3):239-46. doi: 10.1177/1545968311419301. Epub 2011 Aug 29.
PubMed 21875892Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15.
PubMed 21160056Knutson JS, Friedl AS, Hansen KM, Hisel TZ, Harley MY. Convergent Validity and Responsiveness of the SULCS. Arch Phys Med Rehabil. 2019 Jan;100(1):140-143.e1. doi: 10.1016/j.apmr.2018.07.433. Epub 2018 Aug 24.
PubMed 30148996
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Contralaterally Controlled FES for Acute Upper Limb Hemiplegia
- ClinicalTrials.gov ID
- NCT01688856
- Acronym / sponsor ID
- IRB12-00493
- Conditions
- Stroke, Hemiparesis, Hemiplegia
- Keywords
- hand, arm, stroke, hemiplegia, electrical stimulation, recovery, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- Case Western Reserve University, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2013 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 20 Sep 2012 (estimated)
- Results
- Posted 9 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Impaired arm and hand function is one of the most disabling and most common consequences of stroke. The Investigators have developed Contralaterally Controlled Functional Electrical Stimulation (CCFES), an innovative neuromuscular electrical stimulation (NMES) treatment for improving the recovery of hand function after stroke. The purpose of this study is to maximize the treatment effect of CCFES by adding stimulated elbow extension. The specific aims and hypotheses are as follows:
AIM 1: Estimate the effect of Arm+Hand CCFES on upper limb motor impairment and activity limitation.
Hypothesis 1: Stroke survivors treated with Arm+Hand CCFES have better outcomes on upper limb impairment and activity limitation measures than those treated with dose-matched Arm+Hand Cyclic NMES.
AIM 2: Estimate the effect of adding stimulated elbow extension to Hand CCFES.
Hypothesis 2: Stroke survivors treated with Arm+Hand CCFES will have greater reductions in upper limb impairment and activity limitation than those treated with Hand CCFES.
AIM 3: Describe the relationship between treatment effect and time elapsed between stroke onset and start of treatment.
Hypothesis 3: Patients who start Arm+Hand CCFES sooner after their stroke achieve better outcomes.
Detailed description
Loss of arm and hand function is a severely disabling condition that occurs in nearly 75% of the estimated 795,000 Americans who have a new or recurrent stroke each year [Roger 2011]. Upper limb impairment is often characterized by inability to extend the elbow and open the hand. The hope of regaining lost motor function after stroke has been fueled in recent years by the development of new rehabilitation therapies and devices that are aimed at promoting the brain's capacity to reorganize after injury in such a way that restores motor control of paretic limbs [Nudo 2001]. The Investigators' long-term objective is to develop stroke rehabilitation treatments for the hemiparetic upper limb that are optimized for effectiveness, applicability, and deployability.
The primary objective of this project is to estimate the effect of Arm+Hand Contralaterally Controlled Functional Electrical Stimulation (CCFES) in reducing upper limb motor impairment and activity limitation in subacute hemiplegia. CCFES is a treatment aimed at improving recovery of volitional motor function in stroke survivors [Knutson 2007; Knutson 2009; Knutson 2010]. Hand CCFES activates finger and thumb extensors with an intensity of electrical stimulation that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. The Hand CCFES system enables stroke patients to use their impaired hand to practice functional tasks in therapy sessions. CCFES incorporates the following features considered to be important to motor recovery and promoting neuroplasticity: synchronization of motor intent with motor execution of paretic hand opening [Rushton 2003; Kimberley 2004], bilateral symmetric movement [Luft 2004], intensive repetitive hand opening exercises [Lang 2009], and the practice of functional tasks [Nudo 2003]. In a pilot case series study of patients with chronic (> 6 months) post-stroke hemiplegia, all 6 participants experienced some reduction of upper limb motor impairment after several weeks of Hand CCFES [Knutson 2007; Knutson 2009]. The results of a Phase I randomized clinical trial (RCT) of Hand CCFES in 21 patients with subacute (≤ 6 months) hemiplegia suggested that Hand CCFES may be superior to cyclic neuromuscular electrical stimulation (NMES) in reducing upper extremity impairment and activity limitation [Knutson 2011].
In this study, added to the Hand CCFES treatment is stimulated elbow extension controlled by the contralateral elbow. This "next generation" CCFES treatment is called Arm+Hand CCFES. Arm+Hand CCFES therapy is intended to strengthen and improve the motor control of the proximal upper limb as well as the hand, to improve simultaneous reaching and hand opening, a functionally critical movement pattern that is often prevented by paresis and post-stroke flexor synergies. The secondary objective of this project is to evaluate the effect of adding elbow extensor stimulation to the Hand CCFES treatment.
Stroke survivors who are ≤ 2 years post-stroke with upper limb hemiplegia will be randomly assigned to receive 12 weeks of either Arm+Hand CCFES (stimulates elbow extension and hand opening), Hand CCFES (stimulates hand opening), or Arm+Hand Cyclic NMES (stimulates elbow extension and hand opening but with pre-set timing and intensity, i.e., not intention-driven), plus lab-based therapist-guided task practice. Upper limb impairment and activity limitation will be assessed at baseline, 6, 12, 20, 28, and 36 weeks.
This is the first randomized controlled trial of Arm+Hand CCFES in subacute upper extremity hemiplegia. Ultimately, the information learned in this study will serve to accelerate the development of a new treatment for reducing post-stroke disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm+Hand CCFES | Experimental | Device: Electrical StimulatorUses an electrical stimulator that opens the paretic hand and extends the paretic elbow in response to and with an intensity proportional to movement of the contralateral arm and hand. The treatment dose will be approximately 2 hrs per day of self-administered stimulation-mediated exercise at home plus 70 min of functional task practice twice a week in the laboratory for 12 weeks. |
| Hand CCFES | Experimental | Device: Electrical StimulatorUses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand. The treatment dose will be approximately 2 hrs per day of self-administered stimulation-mediated exercise at home plus 70 min of functional task practice twice a week in the laboratory for 12 weeks. |
| Arm+Hand Cyclic NMES | Active comparator | Device: Electrical StimulatorUses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity. The treatment dose will be approximately 2 hrs per day of self-administered stimulation-mediated exercise at home plus 70 min of functional task practice twice a week in the laboratory for 12 weeks. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 21 and ≤ 80
- ≤ 2 years of first clinical hemorrhagic or nonhemorrhagic stroke
- Skin intact on hemiparetic arm and hand
- Able to follow 3-stage commands
- Able to recall 2 of 3 items after 30 minutes
Key exclusion criteria (11 listed)
- Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, Parkinson's Disease, Spinal Cord Injury, Traumatic Brain Injury, Multiple Sclerosis).
- Severely impaired cognition and communication
- Uncontrolled seizure disorder
- History of cardiac arrhythmias with hemodynamic instability
- Cardiac pacemaker or other implanted electronic device
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 StimulatorThe 12-week treatment period consists of two components: 1. Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. If Arm+Hand CCFES or Hand CCFES, the stimulator is used during task practice. 2. Self-administered muscle stimulation exercise performed 10 sessions per week at home using the device. If Arm+Hand CCFES or Hand CCFES, each session is 46 minutes. If Arm+Hand Cyclic NMES, each session is 60 minutes. | Device | Arm+Hand CCFES, Arm+Hand Cyclic NMES, Hand CCFES |
Primary outcome
Change in Box and Block Test (BBT) Score at 6 Months Post-Treatment
Time frame: 2 timepoints: prior to treatment, 6 months post-treatment
The BBT counts how many blocks a participant can pick up, move over a barrier, and release in 60 seconds. Higher scores mean a better outcome.
4 secondary outcomes
Change in Reachable Workspace (RW) at 6 Months Post-Treatment
Time frame: 2 timepoints: prior to treatment, 6 months post-treatment
Change in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-Treatment
Time frame: 2 timepoints: prior to treatment, 6 months post-treatment
Change in Stroke Upper Limb Capacity Scale (SULCS) at 6 Months Post-Treatment
Time frame: 2 timepoints: prior to treatment, 6 months post-treatment
Change in Arm Motor Abilities Test (AMAT) at 6 Months Post-Treatment
Time frame: 2 timepoints: prior to treatment, 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 9 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11439375Nudo RJ, Plautz EJ, Frost SB. Role of adaptive plasticity in recovery of function after damage to motor cortex. Muscle Nerve. 2001 Aug;24(8):1000-19. doi: 10.1002/mus.1104.
- 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 20531158Knutson JS, Chae J. A novel neuromuscular electrical stimulation treatment for recovery of ankle dorsiflexion in chronic hemiplegia: a case series pilot study. Am J Phys Med Rehabil. 2010 Aug;89(8):672-82. doi: 10.1097/PHM.0b013e3181e29bd7.
- 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.
- 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 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 19801058Lang CE, Macdonald JR, Reisman DS, Boyd L, Jacobson Kimberley T, Schindler-Ivens SM, Hornby TG, Ross SA, Scheets PL. Observation of amounts of movement practice provided during stroke rehabilitation. Arch Phys Med Rehabil. 2009 Oct;90(10):1692-8. doi: 10.1016/j.apmr.2009.04.005.
- Background: PubMed 12817650Nudo RJ. Adaptive plasticity in motor cortex: implications for rehabilitation after brain injury. J Rehabil Med. 2003 May;(41 Suppl):7-10. doi: 10.1080/16501960310010070.
- Background: PubMed 21875892Knutson JS, Harley MY, Hisel TZ, Hogan SD, Maloney MM, Chae J. Contralaterally controlled functional electrical stimulation for upper extremity hemiplegia: an early-phase randomized clinical trial in subacute stroke patients. Neurorehabil Neural Repair. 2012 Mar-Apr;26(3):239-46. doi: 10.1177/1545968311419301. Epub 2011 Aug 29.
- Background: PubMed 21160056Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15.
- Derived from this study: PubMed 30148996Knutson JS, Friedl AS, Hansen KM, Hisel TZ, Harley MY. Convergent Validity and Responsiveness of the SULCS. Arch Phys Med Rehabil. 2019 Jan;100(1):140-143.e1. doi: 10.1016/j.apmr.2018.07.433. Epub 2018 Aug 24.
- Cleveland FES CenterLink provided by the sponsor.
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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
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 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 17 inclusion and 11 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 9 Jan 2020. 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 9 Jan 2020). 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 Box and Block Test (BBT) Score at 6 Months Post-Treatment (time frame: 2 timepoints: prior to treatment, 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 NCT01688856, 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 9 Jan 2020.