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StrokeNCT02199795

Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke

A study testing Cyclic Neuromuscular Electrical Stimulation in people with Stroke and Hemiparesis, run by MetroHealth Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a small pilot randomized controlled trial which will enroll both subacute (<6 mos) and chronic (>6 mos) stroke survivors with ankle dorsiflexion weakness. The subjects will be randomized to Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) versus control. Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Stroke, Hemiparesis, Footdrop
What is being tested?
Cyclic Neuromuscular Electrical Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
May 2014to Feb 2015
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 21 to 75 years
  • Minimum of 2 wks from a first clinical non-hemorrhagic or hemorrhagic stroke
  • Medically stable
  • Unilateral lower extremity hemiparesis
  • Ankle dorsiflexor strength of ≤4/5 on the Medical Research Council scale, while seated
  • NMES of the paretic ankle dorsiflexors produces ankle dorsiflexion to neutral without pain.
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  • Full voluntary ROM of the contralateral ankle
  • Skin intact on bilateral lower extremities
  • Able to don the NMES system or caregiver available to assist with device if needed.
  • Able to hear and respond to stimulator auditory cues
  • Able to follow 3-stage commands
  • Able to recall 2 of 3 items after 30 minutes
  • Cognition and communication adequate for safe use of the device based on neurological assessment by physician principal investigator

Who cannot join

  • Severely impaired cognition and communication
  • History of peroneal nerve injury
  • History of Parkinson's, spinal cord injury, traumatic brain injury, or multiple sclerosis
  • Uncontrolled seizure disorder
  • Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
  • Edema of the paretic lower extremity
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  • Absent sensation of paretic lower extremity
  • Evidence of deep venous thrombosis or thromboembolism
  • History of cardiac arrhythmias with hemodynamic instability
  • Cardiac pacemaker or other implanted electronic system
  • Botulinum toxin injections to any lower extremity muscle in the last 3 months
  • Pregnancy
  • Symptomatic peripheral neuropathy
  • Current use of psychoactive medications (except selective serotonin reuptake inhibitor and serotonin-norepinephrine reuptake inhibitor antidepressants)
  • Acetylcholinesterase inhibitor usage
  • Unstable asthmatic condition
  • Metallic implants (including clips and/or wires)
  • Prosthetic heart valves
  • Cardiac, renal or other stent
  • History of claustrophobia
  • Low visual acuity
  • Body weight or body habitus not compatible to MRI machine
  • Medical, psychological, or social concern identified by the principal investigator or co-investigator which suggests inappropriateness of subject participation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

Other trials in United States

About this study

This is a small pilot randomized controlled trial which will enroll both subacute (<6 mos) and chronic (>6 mos) stroke survivors with ankle dorsiflexion weakness. The subjects will be randomized to Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) versus control. The primary objective of this study is to compare the effect of 6-weeks of lower extremity CCNMES, applied in an anti-phase application, on motor impairment and functional mobility to a control group.

Being tested
Contralaterally Controlled Neuromuscular Electrical Stimulation, Cyclic Neuromuscular Electrical Stimulation
Keywords
stroke, hemiplegia, footdrop, electrical stimulation
Medical subject headings
Stroke, Paresis, Peroneal Neuropathies, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contralaterally Controlled Neuromuscular Electrical StimulationDevice

  • Cyclic Neuromuscular Electrical StimulationDevice

Study groups in NCT02199795
Study groupRoleWhat they receive
CCNMESExperimentalContralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.
Receives: Device: Contralaterally Controlled Neuromuscular Electrical Stimulation
Cyclic NMESActive comparatorCyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.
Receives: Device: Cyclic Neuromuscular Electrical Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Lower Extremity Fugl-Meyer Score at End of Treatment

    The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0 (i.e., full scale range 0-34).

    Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged.

    Measured: Baseline and End of Treatment (6 weeks)

Secondary outcomes (3)

  1. Change in 10-Meter Walk Test

    Time to walk 10 m was measured using a stop-watch. For each individual, the time to walk 10 m prior to treatment was subtracted from the time to walk 10 m at end of the 6-week treatment. Then for each treatment group, these changes in time were averaged.

    Measured: Baseline and End of Treatment (6 weeks)

  2. Change in Ankle Movement Tracking Error at End of Treatment

    Ankle dorsiflexion angle was measured continuously using an electrogoniometer. The subject was seated in front of a computer screen which displayed a 30-sec long sine-wave trace scrolling right to left across the screen. The peak to peak amplitude of the sine wave was set equal to the participant's achievable active range of ankle movement and put on a scale of 0 to 100. Three 30-sec trials were run in which the participant's task was to trace the sine wave by moving their paretic ankle. Error was calculated as the average vertical distance between the sine wave and the ankle angle. The lowest error across three trials was taken as the error for that time point.

    Lower errors are considered to be better outcomes.

    For each participant, the error prior to treatment was subtracted from the error at end of the 6-week treatment. Then for each treatment group, these change scores were averaged. A negative change in error scores is considered an improvement.

    Measured: Baseline and End of Treatment (6 weeks)

  3. Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment

    The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time.

    Lower times are considered to be a better outcome.

    For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged.

    Measured: Baseline and End of Treatment (6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

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
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02199795
Sponsor's protocol ID
K23HD060689
Other IDs
K23HD060689
Status last verified
Oct 2017
First submitted
23 Jun 2014
Last updated
8 Nov 2017
Data monitoring committee
No
FDA-regulated drug
No
Individual data sharing
No

Publications

  • Knutson JS, Hansen K, Nagy J, Bailey SN, Gunzler DD, Sheffler LR, Chae J. Contralaterally controlled neuromuscular electrical stimulation for recovery of ankle dorsiflexion: a pilot randomized controlled trial in patients with chronic post-stroke hemiplegia. Am J Phys Med Rehabil. 2013 Aug;92(8):656-65. doi: 10.1097/PHM.0b013e31829b4c16.

    PubMed 23867888

  • Knutson 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 20531158

  • Swinnen SP. Intermanual coordination: from behavioural principles to neural-network interactions. Nat Rev Neurosci. 2002 May;3(5):348-59. doi: 10.1038/nrn807.

    PubMed 11988774

  • Kawashima N, Nozaki D, Abe MO, Akai M, Nakazawa K. Alternate leg movement amplifies locomotor-like muscle activity in spinal cord injured persons. J Neurophysiol. 2005 Feb;93(2):777-85. doi: 10.1152/jn.00817.2004. Epub 2004 Sep 22.

    PubMed 15385590

  • Vasudevan EV, Zehr EP. Multi-frequency arm cycling reveals bilateral locomotor coupling to increase movement symmetry. Exp Brain Res. 2011 Jun;211(2):299-312. doi: 10.1007/s00221-011-2687-y. Epub 2011 Apr 23.

    PubMed 21516330

Questions about this trial

What is this clinical trial studying?

A study testing Cyclic Neuromuscular Electrical Stimulation 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 13 inclusion and 23 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 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Lower Extremity Fugl-Meyer Score at End of Treatment (time frame: Baseline and End of Treatment (6 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 NCT02199795, which also lists 5 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 8 Nov 2017.

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