Healthy ParticipantsNCT05006547
Peroneal Muscles Response to Expected and Unexpected Falls Among Young and Middle-aged Adults Before and After Neuromuscular Training
An observational study of Healthy Participants, run by Ariel University at 1 site in Israel.
Trial summary
Proper functioning of the ankle musculature, specifically peroneal muscles, is crucial for maintaining balance and reducing the risk for falls. Evidence suggests that a decrease in aspects of neuromuscular control already starts at midlife (45-65 years). Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Electromyograph Biofeedback training of the peroneal muscle
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2021to 1 Jul 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy participants- Twenty-five middle-aged (50-65years) and 25 young adults (20-35 years) will be recruited.
Who may be able to join
- Healthy participants
Who cannot join
- Neurological disease accompanied by motor, sensory or cognitive impairment.
- Illness or condition that does not allow strenuous activity.
- Significant orthopedic injury to the back or lower limbs in the last six months, which limits strenuous activity or weight-bearing.
- History of orthopedic injury that includes injury to the knee or ankle ligaments.
- Taking medications that may affect stability or balance. Significant visual impairment that is not corrected using glasses/contact lenses
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ariel University -The Neuromuscular & Human performance laboratory
Ariel
Roee Hayek, rh29493@gmail.com
shmuels@ariel.ac.il
About this study
Official title: Peroneal Muscles Response to Expected and Unexpected Falls Among Young and Middle-aged Adults Before and After Neuromuscular Training: a Cross Sectional-controlled Trial
Proper functioning of the ankle musculature, specifically peroneal muscles, is crucial for maintaining balance and reducing the risk for falls. Evidence suggests that a decrease in aspects of neuromuscular control already starts at midlife (45-65 years). However, there is almost no information regarding the function of the ankle muscles at the middle-age as most experiments have compared young (<35 years) and older subjects (>65 years). Moreover, neuromuscular training can improve the function of ankle muscle in response to perturbation; yet, no previous study has compared the level of effectiveness between middle-aged and young adults.
- Conditions
- Healthy Participants
- Being tested
- Electromyograph Biofeedback training of the peroneal muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyograph Biofeedback training of the peroneal muscleOther
The exercise will be performed with the subject sitting in front of a computer monitor, on an elevated chair, and his feet will be in the air. The examiner will ask the subject to perform a maximum contraction of the paronal muscles, in an open kinematic chain. After reference, the subject will begin a five-minute practice. The practice will be divided into rounds of: eight seconds of muscle work and 15 seconds rest.
| Study group | Role | What they receive |
|---|---|---|
| Young adults | 18<age<35 Receives: Other: Electromyograph Biofeedback training of the peroneal muscle | |
| Middle aged adults | 50<age<65 Receives: Other: Electromyograph Biofeedback training of the peroneal muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to stabilization
Subjects will be asked to jump from a 20 cm high box onto a force plate (i.e., expected fall).
Measured: Within 24 hours
Electromyography of peroneus longus- "The height of the amplitude"- expected fall
Subjects will be asked to jump from a 20 cm high box onto a force plate (i.e., expected fall). electromyography of peroneus longus will be measured the height of the amplitude - expresses the peak of the electrical activity of the muscles.
Measured: Within 24 hours
Electromyography of peroneus longus- "Time to Peak"- expected fall
Subjects will be asked to jump from a 20 cm high box onto a force plate (i.e., expected fall). electromyography of peroneus longus will be measured the "Time to Peak"- describes the time it takes for the Peroneus longus muscle to reach the peak of its electrical activity.
Measured: Within 24 hours
Electromyography of peroneus longus- "Time to Onset"- expected fall
Subjects will be asked to jump from a 20 cm high box onto a force plate (i.e., expected fall). electromyography of peroneus longus will be measured the "Time to Onset" - expresses the period that passes from the beginning of the fall to the initial recruitment of the Peroneus longus.
Measured: Within 24 hours
Electromyography of peroneus longus- "The height of the amplitude"-unexpected fall
Subjects will stand on a platform during a unilateral sudden 30° inversion platform perturbation that resembles an unexpected fall. electromyography of peroneus longus will be measured the "height of the amplitude" - expresses the peak of the electrical activity of the Peroneus longus muscle.
Measured: Within 24 hours
Electromyography of peroneus longus- "Time to Peak"-unexpected fall
Subjects will stand on a platform during a unilateral sudden 30° inversion platform perturbation that resembles an unexpected fall. electromyography of peroneus longus will be measured the "Time to Peak"- describes the time it takes for the Peroneus longus muscle to reach the peak of its electrical activity.
Measured: Within 24 hours
Electromyography of peroneus longus- "Time to Onset"-unexpected fall
Subjects will stand on a platform during a unilateral sudden 30° inversion platform perturbation that resembles an unexpected fall. electromyography of peroneus longus will be measured the "Time to Onset"- expresses the period that passes from the beginning of the fall to the initial recruitment of the Peroneus longos muscle.
Measured: Within 24 hours
Maximal voluntary isometric peroneal contraction force
Subject will perform Maximal voluntary isometric peroneal contraction. The force will measured with dynamometer
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Jul 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ariel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006547
- Sponsor's protocol ID
- AU-HEA-SS-20210304:
- Status last verified
- Mar 2021
- First submitted
- 21 Jul 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hayek R, Gottlieb U, Gutman I, Springer S. Peroneal muscle response to single-leg drop-jump and unexpected leg-drop in young and middle-aged adults before and after one session of neuromuscular training. Eur Rev Aging Phys Act. 2023 Jun 17;20(1):11. doi: 10.1186/s11556-023-00321-8.
PubMed 37330500
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peroneal Muscles Response to Expected and Unexpected Falls Among Young and Middle-aged Adults Before and After Neuromuscular Training: a Cross Sectional-controlled Trial
- ClinicalTrials.gov ID
- NCT05006547
- Acronym / sponsor ID
- AU-HEA-SS-20210304:
- Conditions
- Healthy Participants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ariel UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 16 Aug 2021 (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.
Proper functioning of the ankle musculature, specifically peroneal muscles, is crucial for maintaining balance and reducing the risk for falls. Evidence suggests that a decrease in aspects of neuromuscular control already starts at midlife (45-65 years). However, there is almost no information regarding the function of the ankle muscles at the middle-age as most experiments have compared young (<35 years) and older subjects (>65 years). Moreover, neuromuscular training can improve the function of ankle muscle in response to perturbation; yet, no previous study has compared the level of effectiveness between middle-aged and young adults.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young adults | – | Other: Electromyograph Biofeedback training of the peroneal muscle18<age<35 |
| Middle aged adults | – | Other: Electromyograph Biofeedback training of the peroneal muscle50<age<65 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participants- Twenty-five middle-aged (50-65years) and 25 young adults (20-35 years) will be recruited.
Key inclusion criteria (1 listed)
- Healthy participants
Key exclusion criteria (6 listed)
- Neurological disease accompanied by motor, sensory or cognitive impairment.
- Illness or condition that does not allow strenuous activity.
- Significant orthopedic injury to the back or lower limbs in the last six months, which limits strenuous activity or weight-bearing.
- History of orthopedic injury that includes injury to the knee or ankle ligaments.
- Taking medications that may affect stability or balance. Significant visual impairment that is not corrected using glasses/contact lenses
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 |
|---|---|---|
| Electromyograph Biofeedback training of the peroneal muscleThe exercise will be performed with the subject sitting in front of a computer monitor, on an elevated chair, and his feet will be in the air. The examiner will ask the subject to perform a maximum contraction of the paronal muscles, in an open kinematic chain. After reference, the subject will begin a five-minute practice. The practice will be divided into rounds of: eight seconds of muscle work and 15 seconds rest. | Other | Middle aged adults, Young adults |
Primary outcome
Time to stabilization
Time frame: Within 24 hours
Subjects will be asked to jump from a 20 cm high box onto a force plate (i.e., expected fall).
Electromyography of peroneus longus- "The height of the amplitude"- expected fall
Time frame: Within 24 hours
Subjects will be asked to jump from a 20 cm high box onto a force plate (i.e., expected fall). electromyography of peroneus longus will be measured the height of the amplitude - expresses the peak of the electrical activity of the muscles.
Electromyography of peroneus longus- "Time to Peak"- expected fall
Time frame: Within 24 hours
Subjects will be asked to jump from a 20 cm high box onto a force plate (i.e., expected fall). electromyography of peroneus longus will be measured the "Time to Peak"- describes the time it takes for the Peroneus longus muscle to reach the peak of its electrical activity.
Electromyography of peroneus longus- "Time to Onset"- expected fall
Time frame: Within 24 hours
Subjects will be asked to jump from a 20 cm high box onto a force plate (i.e., expected fall). electromyography of peroneus longus will be measured the "Time to Onset" - expresses the period that passes from the beginning of the fall to the initial recruitment of the Peroneus longus.
Electromyography of peroneus longus- "The height of the amplitude"-unexpected fall
Time frame: Within 24 hours
Subjects will stand on a platform during a unilateral sudden 30° inversion platform perturbation that resembles an unexpected fall. electromyography of peroneus longus will be measured the "height of the amplitude" - expresses the peak of the electrical activity of the Peroneus longus muscle.
Electromyography of peroneus longus- "Time to Peak"-unexpected fall
Time frame: Within 24 hours
Subjects will stand on a platform during a unilateral sudden 30° inversion platform perturbation that resembles an unexpected fall. electromyography of peroneus longus will be measured the "Time to Peak"- describes the time it takes for the Peroneus longus muscle to reach the peak of its electrical activity.
Electromyography of peroneus longus- "Time to Onset"-unexpected fall
Time frame: Within 24 hours
Subjects will stand on a platform during a unilateral sudden 30° inversion platform perturbation that resembles an unexpected fall. electromyography of peroneus longus will be measured the "Time to Onset"- expresses the period that passes from the beginning of the fall to the initial recruitment of the Peroneus longos muscle.
Maximal voluntary isometric peroneal contraction force
Time frame: Within 24 hours
Subject will perform Maximal voluntary isometric peroneal contraction. The force will measured with dynamometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Derived from this study: PubMed 37330500Hayek R, Gottlieb U, Gutman I, Springer S. Peroneal muscle response to single-leg drop-jump and unexpected leg-drop in young and middle-aged adults before and after one session of neuromuscular training. Eur Rev Aging Phys Act. 2023 Jun 17;20(1):11. doi: 10.1186/s11556-023-00321-8.
- 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.
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 Participants, run by Ariel University at 1 site in Israel.
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 1 inclusion and 6 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 16 Aug 2021. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shmuel Springer, Prof. (+972584572869, shmuels@ariel.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to stabilization (time frame: Within 24 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05006547, which also lists 1 linked publication.
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 16 Aug 2021.