The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability
NCT ID: NCT05908214
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2023-10-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Participants prone to cramps will be compared to healthy participants. Patients with restless legs syndrome will be compared to healthy participants.
TREATMENT
NONE
Study Groups
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Stroke patients - training group
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.
wide pulse high frequency neuromuscular electrical stimulation training
Plantar flexors will be stimulated with wide pulse high frequency neuromuscular electrical stimulation 3 times a week for 6 weeks
stroke patients - control group
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.
No interventions assigned to this group
Interventions
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wide pulse high frequency neuromuscular electrical stimulation training
Plantar flexors will be stimulated with wide pulse high frequency neuromuscular electrical stimulation 3 times a week for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* 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:
1. The presence of periodic limb movements
2. A dopaminergic treatment response
3. The presence of RLS in first-degree relatives
4. 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
18 Years
ALL
Yes
Sponsors
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Swiss National Science Foundation
OTHER
University of Lausanne
OTHER
Responsible Party
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Nicolas Place
Professor
Locations
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Bâtiment Synathlon, quartier UNIL-Centre
Lausanne, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-01817
Identifier Type: -
Identifier Source: org_study_id