An interventional study of Percutaneous neuromodulation and Transcutaneous neuromodulation in Stroke/Brain Attack, sponsored by University of Extremadura. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-15.
Sponsored by University of Extremadura · Not applicable, Interventional, and Treatment
INTRODUCTION: Clubfoot, drop foot or clubfoot, is a disorder that prevents reaching 100º of dorsiflexion actively. Its etiology is varied, and may be due to congenital problems, direct alteration of the bone structure, spasticity or shortening of the posterior musculature (triceps suralis), a neurological factor or a combination of several. Thus, we can differentiate between congenital clubfoot and acquired clubfoot. Stroke is one of the main causes of acquired clubfoot, which is due to paralysis of the dorsiflexor musculature and/or spasticity of the plantar flexor musculature. Electrical stimulation is able to increase muscle activation by depolarization of the motor plate and modulation of nerve conduction. This can be done transcutaneously, through surface electrodes or percutaneously through needles, so neuromodulation is presented as a tool applicable to the pathology of the equine foot, if we take into account the increased activation of the dorsiflexors of the foot.
OBJECTIVE: The main objective is to evaluate which of the techniques, percutaneous or transcutaneous, is more effective for the approach of clubfoot in post-stroke patients.
METHODOLOGY: a clinical trial with randomized probabilistic assignment in four groups is proposed: G1 (percutaneous neuromodulation): patients will receive a needle circuit approaching the deep peroneal nerve in an ultrasound-guided manner. They will receive a 20-30Hz symmetrical biphasic current; G2 (transcutaneous neuromodulation): patients will have a superficial electrode circuit placed over the belly of the tibialis anterior muscle. They will receive a symmetrical biphasic current of 20-30Hz; G3 (placebo-percutaneous group): in which the patients will receive the neuromodulation circuit with needles at 0 intensity; G2 (placebo-transcutaneous group): the patients will receive the electrodes at 0 intensity over the belly of the tibialis anterior muscle.
The variables to be analyzed are: anthropometric variables (age, weight, height, BMI), muscle oxygenation (SatO2, O2Hb, HHb and THb), muscle strength of the foot dorsiflexors measured with dynamometer, muscle activation by surface electromyography, active and passive joint balance with goniometry or inclinometer, assessment of gait and balance, assessment of load distribution by static and dynamic pressure platform, spasticity and questionnaire on quality of life and functionality. The acute effects after one intervention session (pre-post intervention of one session) and the effects after a 10-session program will be analyzed.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Extremadura is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Patients will receive a needle circuit approaching the deep peroneal nerve in an ultrasound-guided manner. They will receive a symmetrical biphasic current of 20-30Hz and 250 μs at tolerable intensity.
Device: Percutaneous neuromodulation · Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)
Patients will have a superficial electrode circuit placed over the belly of the tibialis anterior muscle. They will receive a symmetrical biphasic current of 20-30Hz and 250 μs at tolerable intensity.
Device: Transcutaneous neuromodulation · Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)
Patients will receive the neuromodulation circuit with needles at 0 intensity, approaching the deep peroneal nerve in an ultrasound-guided manner
Device: Placebo-percutaneous · Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)
Patients will have the electrodes placed over the tibialis anterior muscle at intensity 0.
Device: Placebo-transcutaneous · Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)
Patients will receive a needle circuit approaching the deep peroneal nerve in an echoguided manner. They will receive a symmetrical biphasic current of 20-30Hz and 250 μs at tolerable intensity.
Patients will have a superficial electrode circuit placed over the belly of the tibialis anterior muscle. They will receive a symmetrical biphasic current of 20-30Hz and 250 μs at tolerable intensity.
Patients will have the neuromodulation circuit placed with needles at 0 intensity, approaching the deep peroneal nerve in an ultrasound-guided manner.
patients will have the electrodes placed over the tibialis anterior muscle at intensity 0.
Study participants who wish to continue may be randomized to receive a 10-session intervention program. The intervention to be received will consist of 10 sessions of percutaneous neuromodulation or 10 sessions of transcutaneous neuromodulation, two sessions per week.
Muscle activity
MDurance surface electromyography
Time frame: 1 day
Displacement of the center of pressures (CoP)
Postural stability: baropodometric platform
Time frame: 1 day
Articular amplitude
Dorsal flexion using goniometer
Time frame: 1 day
Balance
Timed Up and Go (TUG)
Time frame: 1 day
Balance
Tinetti scale: The test is divided into two parts, the assessment of balance on the one hand and gait on the other. To do this we will ask the patient different movements and activities that we will score from 0 to 2, depending on the section, being the maximum score in the balance 16 points and 12 points in the gait.
Time frame: 1 day
Gait
10 minutes walking test
Time frame: 1 day
Tissue oxygen in muscle
Oximeter. Moxy-3 in the thigh
Time frame: 1 day
Muscular strength
Tibialis anterior strength by dynamometry
Time frame: 1 day
Functionality
ECVI-38 scale (Quality of Life Scale for Stroke): 38 items hypothetically grouped into eight domains: physical state, communication, cognition, emotions, feelings, basic activities of daily living, common activities of daily living, and socio-familial functions.; plus two additional questions on sexual function and work activity.
Time frame: 1 day
quality of life index
ECVI-38 scale (Quality of Life Scale for Stroke): 38 items hypothetically grouped into eight domains: physical state, communication, cognition, emotions, feelings, basic activities of daily living, common activities of daily living, and socio-familial functions.; plus two additional questions on sexual function and work activity.
Time frame: 1 day
Spasticity
Ashworth scale: scale from 0 to 4. 0 means mild muscle tone and 4 means high hypertonicity.
Time frame: 1 day
Plan to share: No
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University of Extremadura