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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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 |
|
| G4 (placebo-transcutaneous group) | Placebo Comparator | Patients will have the electrodes placed over the tibialis anterior muscle at intensity 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mª Dolores Apolo Arenas | Badajoz | Spain |
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| 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. |
|
| 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. |
|
| Placebo-transcutaneous | Device | patients will have the electrodes placed over the tibialis anterior muscle at intensity 0. |
|
| 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. |
|
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 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D003025 | Clubfoot |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000070558 | Talipes |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D005532 | Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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