Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation
- Conditions
- Stroke/Brain Attack
- Interventions
- Device: Transcutaneous neuromodulationDevice: Placebo-transcutaneousDevice: Percutaneous neuromodulationDevice: Placebo-percutaneousDevice: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)
- Registration Number
- NCT06365931
- Lead Sponsor
- University of Extremadura
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Age between 18 and 65 years old.
- Have had a stroke or brain damage acquired at least 1 year ago.
- Have a muscle balance in the dorsiflexor musculature of the foot less than or equal to 3/5 on the Daniels scale.
- Contraindication to electrotherapy.
- Needle phobia or panic (in the case of having been assigned to the percutaneous group).
- Severe cognitive impairment that prevents collaboration in the performance of the activity.
- Failure to meet the inclusion criteria.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description G1 (percutaneous neuromodulation) Percutaneous neuromodulation or Transcutaneous neuromodulation (optional) 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. G2 (transcutaneous neuromodulation) 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 and 250 μs at tolerable intensity. G3 (placebo-percutaneous group) 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 G4 (placebo-transcutaneous group) Placebo-transcutaneous Patients will have the electrodes placed over the tibialis anterior muscle at intensity 0. G1 (percutaneous neuromodulation) Percutaneous neuromodulation 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. G4 (placebo-transcutaneous group) Percutaneous neuromodulation or Transcutaneous neuromodulation (optional) Patients will have the electrodes placed over the tibialis anterior muscle at intensity 0. G2 (transcutaneous neuromodulation) 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. G3 (placebo-percutaneous group) Placebo-percutaneous Patients will receive the neuromodulation circuit with needles at 0 intensity, approaching the deep peroneal nerve in an ultrasound-guided manner
- Primary Outcome Measures
Name Time Method Gait 1 day 10 minutes walking test
Muscle activity 1 day MDurance surface electromyography
Displacement of the center of pressures (CoP) 1 day Postural stability: baropodometric platform
Tissue oxygen in muscle 1 day Oximeter. Moxy-3 in the thigh
Muscular strength 1 day Tibialis anterior strength by dynamometry
Articular amplitude 1 day Dorsal flexion using goniometer
Balance 1 day 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.
Functionality 1 day 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.
quality of life index 1 day 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.
Spasticity 1 day Ashworth scale: scale from 0 to 4. 0 means mild muscle tone and 4 means high hypertonicity.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mª Dolores Apolo Arenas
🇪🇸Badajoz, Spain