Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365931
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-03
Brief Title:
Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation
Sponsor:
University of Extremadura
Organization:
University of Extremadura
Study Overview
Official Title:
Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation in the Clubfoot Approach in Post-stroke Patients Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
INTRODUCTION Clubfoot drop foot or clubfoot is a disorder that prevents reaching 100ยบ 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 andor 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None