NCT05006547

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 16, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

July 21, 2021

Last Update Submit

August 8, 2021

Conditions

Outcome Measures

Primary Outcomes (8)

  • Time to stabilization

    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

    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

    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

    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

    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

    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

    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

    Subject will perform Maximal voluntary isometric peroneal contraction. The force will measured with dynamometer

    Within 24 hours

Study Arms (2)

Young adults

18\<age\<35

Other: Electromyograph Biofeedback training of the peroneal muscle

Middle aged adults

50\<age\<65

Other: Electromyograph Biofeedback training of the peroneal muscle

Interventions

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 adultsYoung adults

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy participants- Twenty-five middle-aged (50-65years) and 25 young adults (20-35 years) will be recruited.

You may qualify if:

  • \- Healthy participants

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ariel University -The Neuromuscular & Human performance laboratory

Ariel, Israel

RECRUITING

Related Publications (1)

  • 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.

Central Study Contacts

Shmuel Springer, Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2021

First Posted

August 16, 2021

Study Start

July 1, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

August 16, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations