Clinical trial NCT06365931: Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation
Official title: Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation in the Clubfoot Approach in Post-stroke Patients. Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke/Brain Attack
Keywords: Neuromodulation
clubfoot
percutaneous
transcutaneous
tibialis anterior
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Muscle activity
timeFrame: 1 day
measure: Displacement of the center of pressures (CoP)
timeFrame: 1 day
measure: Articular amplitude
timeFrame: 1 day
measure: Balance
timeFrame: 1 day
measure: Balance
timeFrame: 1 day
measure: Gait
timeFrame: 1 day
measure: Tissue oxygen in muscle
timeFrame: 1 day
measure: Muscular strength
timeFrame: 1 day
measure: Functionality
timeFrame: 1 day
measure: quality of life index
timeFrame: 1 day
measure: Spasticity
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Mª Dolores Apolo Arenas
Study officials:
References: