NCT04174027

Brief Summary

Balance control in respond to an unexpected platform perturbration during standing and walking: comparison between individuals with chronic ankle instability and healthy individuals.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

December 15, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

10 months

First QC Date

October 3, 2019

Last Update Submit

November 20, 2019

Conditions

Chronic Ankle Instability

Keywords

Chronic ankle instability ( CAI )Perturbrationreactive postural controlbalancecenter of pressure - COP

Outcome Measures

Primary Outcomes (2)

  • static balance control in reaction to perturbration

    The angle velocity at the ankle at the moment of loosing postural control while standing

    20 minutes

  • dynamic balance control un reaction to perturbration

    the speed of perturbration at the moment of loosing balance while walking

    10 minutes

Secondary Outcomes (1)

  • Time to returning to original condition

    30 minutes

Other Outcomes (1)

  • movement inside the foot during balance control.

    30 minutes

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Physical education students from Zinman College in Wingate

You may qualify if:

  • age 18-50
  • good health
  • active people

You may not qualify if:

  • Body weight greater than 135 kg
  • Bone instability (non-consolidated fractures, unstable spinal column, severe osteoporosis)
  • Head damage in the year prior to the study
  • Diabetics or Unstable circulation
  • Cardiac (blood) contraindications
  • Vestibular problem
  • Neurological deficits
  • Mechanical ventilation problem
  • Severe vascular disorders of the lower limbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Alon Eliakim, MD

CONTACT

972-9-7471596Eliakim.Alon@clalit.org.il

Michal Pantanowitz, PhD

CONTACT

972-9-7471596michal.pantanowitz@clalit.org.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2019

First Posted

November 22, 2019

Study Start

December 15, 2019

Primary Completion

October 15, 2020

Study Completion

December 15, 2020

Last Updated

November 22, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share