Stroke/Brain AttackNCT06365931
Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation
A study testing Percutaneous neuromodulation, Transcutaneous neuromodulation and Percutaneous neuromodulation or Transcutaneous neuromodulation (optional) in people with Stroke/Brain Attack, run by University of Extremadura at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke/Brain Attack
- What is being tested?
- Percutaneous neuromodulation, Transcutaneous neuromodulation and Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 16 Feb 2024to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Percutaneous neuromodulation, Transcutaneous neuromodulation, Placebo-percutaneous, Placebo-transcutaneous, Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)
- Keywords
- Neuromodulation, clubfoot, percutaneous, transcutaneous, tibialis anterior
- Medical subject headings
- Stroke, Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous neuromodulationDevice
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.
Transcutaneous neuromodulationDevice
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-percutaneousDevice
Patients will have the neuromodulation circuit placed with needles at 0 intensity, approaching the deep peroneal nerve in an ultrasound-guided manner.
Placebo-transcutaneousDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: 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. Receives: Device: Placebo-transcutaneous; Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activity
MDurance surface electromyography
Measured: 1 day
Displacement of the center of pressures (CoP)
Postural stability: baropodometric platform
Measured: 1 day
Articular amplitude
Dorsal flexion using goniometer
Measured: 1 day
Balance
Timed Up and Go (TUG)
Measured: 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.
Measured: 1 day
Gait
10 minutes walking test
Measured: 1 day
Tissue oxygen in muscle
Oximeter. Moxy-3 in the thigh
Measured: 1 day
Muscular strength
Tibialis anterior strength by dynamometry
Measured: 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.
Measured: 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.
Measured: 1 day
Spasticity
Ashworth scale: scale from 0 to 4. 0 means mild muscle tone and 4 means high hypertonicity.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start16 Feb 2024
- Primary completion16 Feb 2024
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke/Brain AttackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Caña Pino, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365931
- Sponsor's protocol ID
- 160224
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation in the Clubfoot Approach in Post-stroke Patients. Clinical Trial
- ClinicalTrials.gov ID
- NCT06365931
- Acronym / sponsor ID
- 160224
- Conditions
- Stroke/Brain Attack
- Keywords
- Neuromodulation, clubfoot, percutaneous, transcutaneous, tibialis anterior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| G1 (percutaneous neuromodulation) | Experimental | Device: Percutaneous neuromodulation, Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)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 | Device: Transcutaneous neuromodulation, Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)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 | Device: Placebo-percutaneous, Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)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 | Device: Placebo-transcutaneous, Device: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)Patients will have the electrodes placed over the tibialis anterior muscle at intensity 0. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous neuromodulationPatients 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 | G1 (percutaneous neuromodulation) |
| Transcutaneous neuromodulationPatients 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 | G2 (transcutaneous neuromodulation) |
| Placebo-percutaneousPatients will have the neuromodulation circuit placed with needles at 0 intensity, approaching the deep peroneal nerve in an ultrasound-guided manner. | Device | G3 (placebo-percutaneous group) |
| Placebo-transcutaneouspatients will have the electrodes placed over the tibialis anterior muscle at intensity 0. | Device | G4 (placebo-transcutaneous group) |
| 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 | G1 (percutaneous neuromodulation), G2 (transcutaneous neuromodulation), G3 (placebo-percutaneous group), G4 (placebo-transcutaneous group) |
Primary outcome
Muscle activity
Time frame: 1 day
MDurance surface electromyography
Displacement of the center of pressures (CoP)
Time frame: 1 day
Postural stability: baropodometric platform
Articular amplitude
Time frame: 1 day
Dorsal flexion using goniometer
Balance
Time frame: 1 day
Timed Up and Go (TUG)
Balance
Time frame: 1 day
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.
Gait
Time frame: 1 day
10 minutes walking test
Tissue oxygen in muscle
Time frame: 1 day
Oximeter. Moxy-3 in the thigh
Muscular strength
Time frame: 1 day
Tibialis anterior strength by dynamometry
Functionality
Time frame: 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.
quality of life index
Time frame: 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
Time frame: 1 day
Ashworth scale: scale from 0 to 4. 0 means mild muscle tone and 4 means high hypertonicity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous neuromodulation, Transcutaneous neuromodulation and Percutaneous neuromodulation or Transcutaneous neuromodulation (optional) in people with Stroke/Brain Attack, run by University of Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle activity (time frame: 1 day). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.