The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Lausanne

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • wide pulse high frequency neuromuscular electrical stimulation training

    Other intervention

    Plantar flexors will be stimulated with wide pulse high frequency neuromuscular electrical stimulation 3 times a week for 6 weeks

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Stroke patients - training groupExperimental treatment 1 intervention
Group B: stroke patients - control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in maximal voluntary contraction force

Change from baseline maximal voluntary contraction force after the six-week training period in stroke patients

Time frame
through study completion, an average of 8 weeks
2

Change in NMES-evoked force

Change from baseline NMES-evoked force after the six-week training period

Time frame
through study completion, an average of 8 weeks
3

NMES-evoked force

Comparison of NMES-evoked force in plantar flexor muscles between patients (prone to cramps or restless legs) and healthy volunteers

Time frame
through study completion, an average of 2 weeks
4

Change in estimates of persistent inward current (Delta F assessed with high-density surface electromyography and/ or the torque measured during vibration after the last bout of NMES)

Change from baseline estimates of persistent inward current after the six-week training period in stroke patients

Time frame
through study completion, an average of 8 weeks

Secondary outcomes

1

Change in voluntary activation level and contractile properties of the plantar flexor muscles

Change from baseline voluntary activation level and contractile properties of the plantar flexor muscles after the six-week training period in stroke patients

Time frame
through study completion, an average of 8 weeks
2

voluntary activation level and contractile properties of the plantar flexor muscles

comparison of voluntary activation level and contractile properties of the plantar flexor muscles between patients (prone to cramps or restless legs) and healthy volunteers

Time frame
through study completion, an average of 2 weeks
3

change in spasticity at the ankle joint level for stroke patients

Change from baseline Ashworth scale score (minimal score 0, maximal score 4, a higher score means a worst outcome) after the six-week training period in stroke patients

Time frame
through study completion, an average of 8 weeks
4

10-m walking test (s)

functional test

Time frame
through study completion, an average of 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Lausanne

Lead sponsor

Swiss National Science Foundation

Collaborator