- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05006547
Peroneal Muscles Response to Expected and Unexpected Falls Among Young and Middle-aged Adults Before and After Neuromuscular Training
August 8, 2021 updated by: Ariel University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shmuel Springer, Prof.
- Phone Number: +972584572869
- Email: shmuels@ariel.ac.il
Study Locations
-
-
-
Ariel, Israel
- Recruiting
- Ariel University -The Neuromuscular & Human performance laboratory
-
Contact:
- Email: shmuels@ariel.ac.il
-
Principal Investigator:
- shmuel springer
-
Contact:
- Roee Hayek
- Email: rh29493@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy participants- Twenty-five middle-aged (50-65years) and 25 young adults (20-35 years) will be recruited.
Description
Inclusion Criteria:
- Healthy participants
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Young adults
18<age<35
|
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.
|
|
Middle aged adults
50<age<65
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Within 24 hours
|
|
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.
|
Within 24 hours
|
|
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.
|
Within 24 hours
|
|
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.
|
Within 24 hours
|
|
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.
|
Within 24 hours
|
|
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.
|
Within 24 hours
|
|
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.
|
Within 24 hours
|
|
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
|
Within 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Anticipated)
July 1, 2022
Study Completion (Anticipated)
July 1, 2022
Study Registration Dates
First Submitted
July 21, 2021
First Submitted That Met QC Criteria
August 8, 2021
First Posted (Actual)
August 16, 2021
Study Record Updates
Last Update Posted (Actual)
August 16, 2021
Last Update Submitted That Met QC Criteria
August 8, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- AU-HEA-SS-20210304:
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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