Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation

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.

Conditions

• Stroke/Brain Attack

Interventions

DEVICE

Percutaneous neuromodulation

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.

DEVICE

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.

DEVICE

Placebo-percutaneous

Patients will have the neuromodulation circuit placed with needles at 0 intensity, approaching the deep peroneal nerve in an ultrasound-guided manner.

DEVICE

Placebo-transcutaneous

patients will have the electrodes placed over the tibialis anterior muscle at intensity 0.

DEVICE

Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)

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.

Sponsors & Collaborators

• University of Extremadura

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-16

Primary Completion

2024-02-16

Completion

2024-04-30

Countries

• Spain

Study Locations