Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation

U

University of Extremadura

Status

Active, not recruiting

Conditions

Stroke/Brain Attack

Treatments

Device: Placebo-percutaneous
Device: Placebo-transcutaneous
Device: Transcutaneous neuromodulation
Device: Percutaneous neuromodulation
Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)

Study type

Interventional

Funder types

Other

Identifiers

NCT06365931
160224

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 4 patient groups, including a placebo group

G1 (percutaneous neuromodulation)
Experimental group
Description:
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.
Treatment:
Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)
Device: Percutaneous neuromodulation
G2 (transcutaneous neuromodulation)
Experimental group
Description:
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.
Treatment:
Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)
Device: Transcutaneous neuromodulation
G3 (placebo-percutaneous group)
Placebo Comparator group
Description:
Patients will receive the neuromodulation circuit with needles at 0 intensity, approaching the deep peroneal nerve in an ultrasound-guided manner
Treatment:
Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)
Device: Placebo-percutaneous
G4 (placebo-transcutaneous group)
Placebo Comparator group
Description:
Patients will have the electrodes placed over the tibialis anterior muscle at intensity 0.
Treatment:
Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)
Device: Placebo-transcutaneous

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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