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Electrical Muscle Stimulation Training for Stroke, Cramps and Restless Legs

Tests electrical muscle stimulation training in adults with stroke, cramps or restless legs.

Key facts

Who runs it
University of Lausanne
Where
Lausanne, SwitzerlandSee the site
Trial code
Registry title
The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability
Status
Recruiting
People taking part
110 people, planned
Started
1 Oct 2023
Expected to end
31 Dec 2026
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • wide pulse high frequency neuromuscular electrical stimulation training
Record updated
28 November 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults from four groups: stroke patients with leg spasticity, people with night-time muscle cramps, people with restless legs syndrome, and healthy volunteers.

Age
18 years and older
Sex
All sexes
Disease stage
Stroke group: first-ever stroke at least 6 months ago with weakness on one side, spasticity of the calf muscles (Modified Ashworth Score 1 or more), poor ankle control when walking, and able to walk at least 10 m. Restless legs group: primary restless legs syndrome meeting the IRLSSG diagnostic criteria.
Earlier treatment
Stroke group: no antispastic medication (baclofen, tizanidine, tolperisone, benzodiazepines, dantrolene, or botulinum toxin to the calf muscles in the last 6 months) and no surgery for drop foot. Cramp group: not being treated for muscle cramps.

Main reasons for not taking part

  • Any reason that makes neuromuscular electrical stimulation unsafe
  • Stroke group: loss of feeling on the surface of the affected lower leg
  • Stroke group: other orthopedic or neurological disorders affecting walking
  • Stroke group: cannot understand the study or give informed consent
  • Healthy group: any neurological disease

The registry criteria, word for word

Show all 28 criteriaShow less

Other criteria

  • STROKE PATIENTS:
  • Diagnosis of first-ever stroke (ischemic or hemorrhagic) with unilateral motor deficits from at least 6 months. Stroke will have to be confirmed from medical records and/or radiological imaging (CT scan or MRI)
  • Inadequate ankle control during gait defined as ankle dorsiflexion less than 5° during stance phase and 0° during swing phase; 0° = ankle neutral position)
  • Passive range of motion of ankle dorsiflexion at least to neutral position
  • Ability to walk at least 10 m with or without assistive devices
  • Spasticity at the triceps surae (either soleus and/or gastrocnemii) considered as a Modified Ashworth Sore ≥1
  • Being available for the study period and willing to participate
  • No contraindication to neuromuscular electrical stimulation; Contraindications for stroke patients:
  • Surface sensory loss of affected lower leg (defined as incapacity to feel the 60-g touch using the Semmes-Weinstein monofilament test)
  • Patients unable to understand indications or to provide informed consent
  • A history of orthopedic or other neurological disorders affecting walking function
  • A history of surgery to correct drop foot (ankle fixation)
  • Patients under antispastic medication (baclofen, tizanidine, tolperisone, benzodiazepines, dantrolene or botulinum toxin to the plantar flexor muscles in the last 6 months); PEOPLE PRONE TO MUSCLE CRAMPS:
  • Reporting nocturnal muscle cramps (the assessment will be done through a questionnaire)
  • Not being treated for muscle cramps
  • Being available for the study period and willing to participate
  • No contraindication to neuromuscular electrical stimulation; PATIENTS WITH RESTLESS LEGS SYNDROME:; To be included in the study, RLS patients will have to satisfy the Diagnostic criteria for RLS published by the International Restless Legs Syndrome StudyGroup (IRLSSG). All five key clinical features are required for the diagnosis:
  • An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. Sometimes the urge to move is present without the uncomfortable sensations, and sometimes the arms or other body parts are involved in addition to the legs
  • The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting
  • The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues
  • The urge to move or unpleasant sensations are worse in the evening or night than during the day, or only occur in the evening or night. When symptoms are severe, the worsening at night may not be noticeable but must have been previously present
  • Symptoms are not solely accounted for by another medical or behavioral condition, such as leg cramps or habitual foot tapping
  • No contraindication to neuromuscular electrical stimulation; They will also have to satisfy the following criteria:
  • Diagnosis of primary RLS corresponding to:; The presence of periodic limb movements; A dopaminergic treatment response; The presence of RLS in first-degree relatives; A lack of profound daytime sleepiness
  • Being available for the study period and willing to participate; HEALTHY PARTICIPANTS:
  • No neurological disease
  • No contraindication to neuromuscular electrical stimulation
  • Being available for the study period and willing to participate

Where in Switzerland

  • Bâtiment Synathlon, quartier UNIL-CentreLausanne, SwitzerlandContact: Nicolas Place, PhDTaking people

About the trial

What the trial wants to find out

In the present project, the investigators aim at proposing innovative ways of investigating spinal motoneuron hyperexcitability to counteract the associated impairments by using wide pulse high frequency neuromuscular electrical stimulation (WPHF NMES) in various populations. The investigators will use WPHF NMES contractions as a model to gain insights into the mechanisms underlying muscle cramps, restless legs syndrome or stroke-induced spasticity as there is evidence that they share common underlying mechanisms. The investigators will then use WPHF NMES as a training modality to improve plantar flexor neuromuscular function in stroke patients by taking advantage of their motoneuronal hyperexcitability.

The 2 groups in the trial

  • Stroke patients - training groupTreatment being tested

    Participants in this group will take part in a 6-week WPHF NMES training period and plantar flexor neuromuscular function will be assessed before and after training.

    Treatment: wide pulse high frequency neuromuscular electrical stimulation training

  • stroke patients - control groupNo study treatment, for comparison

    Participants in this group will keep their daily life activities for 6 weeks and plantar flexor neuromuscular function will be assessed before and after training.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability
Plain-language title
Electrical Muscle Stimulation Training for Stroke, Cramps and Restless LegsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
28 November 2023