Effect of TENS 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 purpose of this clinical trial is to evaluate whether Transcutaneous Electrical Nerve Stimulation (TENS) is effective in reducing spasticity in adults with post-stroke spasticity. The primary research question is whether TENS can reduce the severity of spasticity. The effectiveness of TENS will be assessed by comparing spasticity-related outcomes measured before, during, and after the intervention. Participants will first undergo a one-hour baseline monitoring period, during which assessments will be conducted at 10-minute intervals. This will be followed by a 30-minute TENS intervention and a two-hour follow-up period, with assessments performed every 10 minutes. One participant will repeat this protocol once daily for three consecutive days, whereas the remaining three participants will undergo the procedure on a single occasion.
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.
At least 6 months post-stroke (chronic phase).
Provision of voluntary, written informed consent prior to study enrollment.
Disqualifiers
Age <18 or >70 year
Contraindications to transcutaneous electrical nerve stimulation (e.g., implanted electronic devices, 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
Transcutaneous electrical nerve stimulation (TENS)
DeviceTranscutaneous electrical nerve stimulation (TENS) will be applied over the projection area of the paretic wrist flexor muscles (flexor carpi radialis) for 30 minutes. Stimulation parameters will consist of symmetrical biphasic rectangular pulses at a frequency of 100 Hz and a pulse duration of 200 μs. Stimulation intensity will be adjusted to produce a clearly perceived sensory sensation without visible muscle contraction or discomfort.
Treatment groups
4 Participants
are divided into 1 treatment groupGroup A: Transcutaneous electrical nerve stimulation (TENS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Angle of Muscle Reaction
The Angle of Muscle Reaction (AMR) is defined as the joint angle at which a catch response is elicited in the wrist flexor muscles (flexor carpi radialis and flexor carpi ulnaris) during passive stretch performed at the highest achievable velocity. Higher values indicate lower spasticity.
Time frame
From baseline assessment through completion of study participation (1 to 3 days, depending on the assigned experimental design).2
Hmax / Mmax ratio
The Hmax/Mmax ratio is an electrophysiological measure of spinal motor neuron excitability obtained from flexor carpi radialis H-reflex recordings. Higher values indicate greater spinal motor neuron excitability.
Time frame
From baseline assessment through completion of study participation (1 to 3 days, depending on the assigned experimental design).Sponsors and contacts
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Source ClinicalTrials.gov
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