Effect of NMES on Spasticity
ConditionPost-Stroke Spasticity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIzmir Katip Celebi University
About this trial
The goal of this clinical trial is to learn if neuromuscular electrical stimulation (NMES) works to treat spasticity in adult patients with spasticity related to stroke. The main question it aims to answer is:
• Does NMES reduces the severity of spasticity? Researchers will compare NMES treatment to baseline and non-stimulation periods to see if NMES works to treat spasticity.
Participants will:
• first undergo an initial assessment at 10-minute intervals for one hour, followed by 20 minutes of NMES exposure, and subsequent post-treatment assessments at 10-minute intervals for two hours. This daily procedure will be repeated over four days for one patient, and performed only once for the remaining three patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 70 years
Post-stroke wrist flexor spasticity scored as Grade 2 or 3 on the Australian Spasticity Assessment Scale (ASAS), specifically selecting patients whose passive stretch resistance (post-catch response) can be easily overcome to ensure accurate and unconfounded electrophysiological evaluation.
Provision of voluntary, written informed consent prior to study enrollment.
Disqualifiers
Age <18 or >70 year
Contraindications to neuromuscular electrical stimulation (e.g., active electronic implants, history of epilepsy, or localized skin lesions preventing electrode placement)
Concomitant wrist contracture or pain sufficient to impede clinical evaluation
Structural abnormalities of the elbow joint obstructing median nerve stimulation
Trial design
Design model
Single group
Treatments tested in this trial
Neuromuscular electrical stimulation (NMES)
DeviceNeuromuscular electrical stimulation (NMES) (a symmetric, biphasic, rectangular waveform) will be administered to the antagonist wrist extensors (extensor carpi radialis longus/brevis and extensor carpi ulnaris) of the spastic wrist flexors in the B phase. The configuration consists of an application duration of 20 minutes, a stimulation frequency of 35 Hz, and a pulse duration of 300 μs. The duty cycle will feature a 20-second ON time and 20-second OFF time (1:1 ratio), with ramp-up and ramp-down durations set at 5 seconds.
Neuromuscular electrical stimulation (NMES)
DeviceNeuromuscular electrical stimulation (NMES) is a therapeutic modality used in neurorehabilitation. By delivering transcutaneous electrical currents, NMES elicits repetitive, patterned muscle contractions to augment or restore motor functions.
Treatment groups
4 Participants
are divided into 1 treatment groupGroup A: Neuromuscular electrical stimulation (NMES)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Angle of Muscle Reaction
The Angle of Muscle Reaction is the specific joint angle at which a catch response is elicited in the target muscles (flexor carpi radialis and flexor carpi ulnaris) during a passive stretch delivered at the highest possible velocity.
Time frame
From enrollment up to 1 day (Stages 1 and 3) or 2 to 4 days (Stage 2), depending on the assigned stage.2
Hmax / Mmax ratio
The Hmax / Mmax ratio serves as an objective electrophysiological index of spinal motor neuron pool excitability. Although it does not directly measure velocity-dependent mechanical resistance, this neurophysiological marker quantifies spinal hyperexcitability, thereby providing a critical adjunct to subjective clinical scales.
Time frame
From enrollment to the completion of treatment, varying by stage: 1 day for Stages 1 and 3, and 2 to 4 days for Stage 2.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: