Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation

Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation in the Clubfoot Approach in Post-stroke Patients. Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke/Brain Attack
• Intervention / Treatment: Device: Percutaneous neuromodulation; Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional); Device: Transcutaneous neuromodulation; Device: Placebo-percutaneous; Device: Placebo-transcutaneous

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Badajoz, Spain
    • Mª Dolores Apolo Arenas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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: 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.
Experimental: 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.	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.; 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.
Placebo Comparator: 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	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.; 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.
Placebo Comparator: G4 (placebo-transcutaneous group); 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.; Device: Placebo-transcutaneous; patients will have the electrodes placed over the tibialis anterior muscle at intensity 0.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Extremadura

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2024
• Primary Completion (Actual): February 16, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Neuromodulation; percutaneous; clubfoot; transcutaneous; tibialis anterior
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 160224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No