Healthy SubjectsNCT05635721
Influence of Different Ankle Positions on Nerve Conduction Parameters of Deep Peroneal Nerve
An observational study of Healthy Subjects, run by Cairo University at 1 site in Egypt.
Trial summary
BACKGROUND: The deep peroneal nerve arises as a branch of the common peroneal nerve which courses around the neck of the fibula. The motor component of deep peroneal nerve is responsible for innervating the anterior compartment of the lower leg which includes the tibialis anterior, extensor hallucis longus, extensor… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- How many people
- 31 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2022to 26 Jan 2023
- Phase
- Observational
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 31 healthy subjects of both genders will be recruited to participate in this study
Who may be able to join
- Healthy subjects.
- Age ranges from 20 to 40 years because longer latencies and slower nerve conduction velocity are seen significantly with increasing age.
- All participants will be selected with body mass index (BMI) between 18.5 and 24.9kg/cm2 .
Who cannot join
- Elderly subjects.
- Pregnant women.
- Subjects with history of or risk factors for peripheral nerve lesions.
- Obese subjects.
- Subjects with any foot deformity.
- History of lower limb fractures.
Show all 11Show fewer
- History of surgery to lower limbs
- Diabetic patients.
- Patients with cardiovascular disorders.
- Hypertensive patients.
- Women wearing high heeled shoes.
Trial locations and contacts
1 site in 1 country.
About this study
BACKGROUND:
The deep peroneal nerve arises as a branch of the common peroneal nerve which courses around the neck of the fibula. The motor component of deep peroneal nerve is responsible for innervating the anterior compartment of the lower leg which includes the tibialis anterior, extensor hallucis longus, extensor digitorum longus, and peroneus tertius muscles.
Read more
Nerve conduction velocity shortly known as "NCV" tests are used determine the speed of the electrical signals moving along a specific peripheral nerve .This will be helpful in localizing the site of entrapment of peripheral nerves and useful for assessing both recovery and prognosis of any injury to peripheral nervesthere are numerous aspects that could influence nerve conduction study.
Although changes in joint position have been reported in several studies to affect nerve conduction velocity of peripheral nerves. the effect of changing ankle joint position on deep peroneal NCV has not been repor Purpose
This study will investigate the effect of different ankle positions on:
- Deep peroneal nerve distal motor latency across ankle joint.
- Deep peroneal nerve sensory onset latency across ankle joint
Read the detailed description
31healthy subjects of both genders with age ranging from 20to 40years old were examined for motor distal latency and sensory onset latency at three different ankle positions :neutral,20degrees dorsiflexion and 40degrees plantar flexion
- Conditions
- Healthy Subjects
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep peroneal nerve motor distal latency
Motor distal latency: It is the time between the distal stimulus and the onset of compound muscle action potential(CMAP)at recording muscles
Measured: 30 minutes for each participant
Deep peroneal nerve sensory onset latency
: It is the time taken from the stimulus artifact to the initial negative deflection of the sensory nerve action potential (SNAP)
Measured: 30 minutes for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start5 Dec 2022
- Primary completion3 Jan 2023
- Study completion26 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Salah Abd-Elfattah, Cairo University
- Investigators
- Mahmoud Salah, Principal investigator, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635721
- Sponsor's protocol ID
- P.T.REC/012/004076
- Status last verified
- Jan 2023
- First submitted
- 23 Nov 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Ankle Positions on Nerve Conduction Parameters of Deep Peroneal Nerve
- ClinicalTrials.gov ID
- NCT05635721
- Acronym / sponsor ID
- P.T.REC/012/004076
- Conditions
- Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 2 Dec 2022 (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.
BACKGROUND:
The deep peroneal nerve arises as a branch of the common peroneal nerve which courses around the neck of the fibula. The motor component of deep peroneal nerve is responsible for innervating the anterior compartment of the lower leg which includes the tibialis anterior, extensor hallucis longus, extensor digitorum longus, and peroneus tertius muscles.
Nerve conduction velocity shortly known as "NCV" tests are used determine the speed of the electrical signals moving along a specific peripheral nerve .This will be helpful in localizing the site of entrapment of peripheral nerves and useful for assessing both recovery and prognosis of any injury to peripheral nervesthere are numerous aspects that could influence nerve conduction study.
Although changes in joint position have been reported in several studies to affect nerve conduction velocity of peripheral nerves. the effect of changing ankle joint position on deep peroneal NCV has not been repor Purpose
This study will investigate the effect of different ankle positions on:
- Deep peroneal nerve distal motor latency across ankle joint.
- Deep peroneal nerve sensory onset latency across ankle joint
Detailed description
31healthy subjects of both genders with age ranging from 20to 40years old were examined for motor distal latency and sensory onset latency at three different ankle positions :neutral,20degrees dorsiflexion and 40degrees plantar flexion
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 31 healthy subjects of both genders will be recruited to participate in this study
Key inclusion criteria (3 listed)
- Healthy subjects.
- Age ranges from 20 to 40 years because longer latencies and slower nerve conduction velocity are seen significantly with increasing age.
- All participants will be selected with body mass index (BMI) between 18.5 and 24.9kg/cm2 .
Key exclusion criteria (11 listed)
- Elderly subjects.
- Pregnant women.
- Subjects with history of or risk factors for peripheral nerve lesions.
- Obese subjects.
- Subjects with any foot deformity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Deep peroneal nerve motor distal latency
Time frame: 30 minutes for each participant
Motor distal latency: It is the time between the distal stimulus and the onset of compound muscle action potential(CMAP)at recording muscles
Deep peroneal nerve sensory onset latency
Time frame: 30 minutes for each participant
: It is the time taken from the stimulus artifact to the initial negative deflection of the sensory nerve action potential (SNAP)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
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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.
Mahmoud Salah principal investigator
faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subjects, run by Cairo University at 1 site in Egypt.
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 11 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: finished, as of the sponsor's last update on 30 Jan 2023. 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 Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Deep peroneal nerve motor distal latency (time frame: 30 minutes for each participant). The study lists 2 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 30 Jan 2023.