Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation

NCT ID: NCT06365931

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-16
• Study Completion Date: 2024-04-30

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.

Conditions

Stroke/Brain Attack

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

G1 (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.

Group Type: EXPERIMENTAL

Percutaneous neuromodulation

Intervention Type: DEVICE

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.

Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)

Intervention Type: DEVICE

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.

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 and 250 μs at tolerable intensity.

Group Type: EXPERIMENTAL

Transcutaneous neuromodulation

Intervention Type: DEVICE

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.

Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)

Intervention Type: DEVICE

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.

G3 (placebo-percutaneous group)

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

Group Type: PLACEBO_COMPARATOR

Placebo-percutaneous

Intervention Type: DEVICE

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

Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)

Intervention Type: DEVICE

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.

G4 (placebo-transcutaneous group)

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

Group Type: PLACEBO_COMPARATOR

Placebo-transcutaneous

Intervention Type: DEVICE

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

Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Placebo-transcutaneous

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

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Extremadura

OTHER

Sponsor Role: lead

Responsible Party

Alejandro Caña Pino

Clinical Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mª Dolores Apolo Arenas

Badajoz, , Spain

Countries

Spain

Other Identifiers

160224

Identifier Type: -

Identifier Source: org_study_id