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临床试验/NCT06365931
NCT06365931Unknown不适用

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

University of Extremadura1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年2月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Muscle activity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Muscle activity

时间窗: 1 day

MDurance surface electromyography

Displacement of the center of pressures (CoP)

时间窗: 1 day

Postural stability: baropodometric platform

Gait

时间窗: 1 day

10 minutes walking test

Articular amplitude

时间窗: 1 day

Dorsal flexion using goniometer

Functionality

时间窗: 1 day

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.

Tissue oxygen in muscle

时间窗: 1 day

Oximeter. Moxy-3 in the thigh

Muscular strength

时间窗: 1 day

Tibialis anterior strength by dynamometry

quality of life index

时间窗: 1 day

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.

Spasticity

时间窗: 1 day

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

Balance

时间窗: 1 day

Timed Up and Go (TUG)

次要结局

未报告次要终点

研究者

发起方
University of Extremadura
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alejandro Caña Pino

Clinical Proffesor

University of Extremadura

研究点 (1)

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