Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation

NCT06365931 | Active Not Recruiting

• 1 other identifier: 160224
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Neuromodulation; clubfoot; percutaneous; transcutaneous; tibialis anterior

Outcome Measures

Primary Outcomes (11)

• Muscle activity

  MDurance surface electromyography

  1 day

• Displacement of the center of pressures (CoP)

  Postural stability: baropodometric platform

  1 day

• Articular amplitude

  Dorsal flexion using goniometer

  1 day

• Balance

  Timed Up and Go (TUG)

  1 day

• Balance

  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.

  1 day

• Gait

  10 minutes walking test

  1 day

• Tissue oxygen in muscle

  Oximeter. Moxy-3 in the thigh

  1 day

• Muscular strength

  Tibialis anterior strength by dynamometry

  1 day

• Functionality

  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.

  1 day

• quality of life index

  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.

  1 day

• Spasticity

  Ashworth scale: scale from 0 to 4. 0 means mild muscle tone and 4 means high hypertonicity.

  1 day

Study Arms (4)

G1 (percutaneous neuromodulation)

EXPERIMENTAL

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.

Device: Percutaneous neuromodulation; Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)

G2 (transcutaneous neuromodulation)

EXPERIMENTAL

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: Transcutaneous neuromodulation; Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)

G3 (placebo-percutaneous group)

PLACEBO COMPARATOR

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

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

G4 (placebo-transcutaneous group)

PLACEBO COMPARATOR

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

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

Interventions

Percutaneous neuromodulation 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.

G1 (percutaneous neuromodulation)

Transcutaneous neuromodulation 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.

G2 (transcutaneous neuromodulation)

Placebo-percutaneous DEVICE

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

G3 (placebo-percutaneous group)

Placebo-transcutaneous DEVICE

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

G4 (placebo-transcutaneous group)

Percutaneous neuromodulation or Transcutaneous neuromodulation (optional) 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.

G1 (percutaneous neuromodulation); G2 (transcutaneous neuromodulation); G3 (placebo-percutaneous group); G4 (placebo-transcutaneous group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Extremadura: lead

Study Sites (1)

Mª Dolores Apolo Arenas

Badajoz, Spain

Location

MeSH Terms

Conditions

Stroke; Clubfoot

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Proffesor

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 15, 2024
• Study Start: February 16, 2024
• Primary Completion: February 16, 2024
• Study Completion: April 30, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)