Chronic Ankle InstabilityNCT04174027
The Effect of Perturbration on Balance Control in Adults
An observational study of Chronic Ankle Instability, run by Meir Medical Center.
Trial summary
Balance control in respond to an unexpected platform perturbration during standing and walking: comparison between individuals with chronic ankle instability and healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Ankle Instability
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2019to 15 Dec 2020
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Physical education students from Zinman College in Wingate
Who may be able to join
- age 18-50
- good health
- active people
Who cannot join
- 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
Show all 9Show fewer
- Neurological deficits
- Mechanical ventilation problem
- Severe vascular disorders of the lower limbs
Trial locations and contacts
No sites are listed yet.
About this study
Balance control in respond to an unexpected platform perturbration during standing and walking: comparison between individuals with chronic ankle instability and healthy individuals.
Read the detailed description
An unexpected postural perturbration is a major risk factor of falls and injuries during gait. A postural perturbration is a sudden change in conditions that displaces the body posture away from equilibrium. Reactive postural control response is an immediate ( 70-120 ms ) automatic "like reflex" response which is initiated by unexpected postural perturbration in order to maintain balance. Even among young healthy adults there could be a problem in balance performance which does not become evident untill a slip or a trip or any other sudden perturbration happens. Thus a simple test of pertubration while standing or walking can identify a problem .
This study is comparing the reactive postural control of physical education students who suffer from chronic ankle instability (CAI) to healthy students on a Perturbation Treadmill. The device consists of a treadmill mounted on a moving force plate platform. The platform moves in the medial/ lateral plains to simulate a slip and a trip in both the standing and walking phase. Their reactive postural control is tested in a few conditions: standing on both legs - eyes open and eyes closed, in tandem standing, standing on one leg and in walking. In each condition the perturbration is given every 5-15 seconds in different speed and in unexpected direction (right /left). Lost of balance control is any change in the original location of the foot in standing conditions or stepping out of the treadmill.
- Conditions
- Chronic Ankle Instability
- Keywords
- Chronic ankle instability ( CAI ), Perturbration, reactive postural control, balance, center of pressure - COP
What is being measured
The primary outcome is the main question the study is designed to answer.
static balance control in reaction to perturbration
The angle velocity at the ankle at the moment of loosing postural control while standing
Measured: 20 minutes
dynamic balance control un reaction to perturbration
the speed of perturbration at the moment of loosing balance while walking
Measured: 10 minutes
Secondary outcomes (1)
Time to returning to original condition
How much time it takes to come back to the original step (Center of Pressure - COP) after the perturbration
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start15 Dec 2019 (estimated)
- Primary completion15 Oct 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle InstabilityStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174027
- Sponsor's protocol ID
- MeirMc102-19CTIL
- Status last verified
- Nov 2019
- First submitted
- 3 Oct 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perturbration on Balance Control in Adults
- ClinicalTrials.gov ID
- NCT04174027
- Acronym / sponsor ID
- MeirMc102-19CTIL
- Conditions
- Chronic Ankle Instability
- Keywords
- Chronic ankle instability ( CAI ), Perturbration, reactive postural control, balance, center of pressure - COP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 15 Dec 2019 (estimated)
- Primary completion
- 15 Oct 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 22 Nov 2019 (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.
Balance control in respond to an unexpected platform perturbration during standing and walking: comparison between individuals with chronic ankle instability and healthy individuals.
Detailed description
An unexpected postural perturbration is a major risk factor of falls and injuries during gait. A postural perturbration is a sudden change in conditions that displaces the body posture away from equilibrium. Reactive postural control response is an immediate ( 70-120 ms ) automatic "like reflex" response which is initiated by unexpected postural perturbration in order to maintain balance. Even among young healthy adults there could be a problem in balance performance which does not become evident untill a slip or a trip or any other sudden perturbration happens. Thus a simple test of pertubration while standing or walking can identify a problem .
This study is comparing the reactive postural control of physical education students who suffer from chronic ankle instability (CAI) to healthy students on a Perturbation Treadmill. The device consists of a treadmill mounted on a moving force plate platform. The platform moves in the medial/ lateral plains to simulate a slip and a trip in both the standing and walking phase. Their reactive postural control is tested in a few conditions: standing on both legs - eyes open and eyes closed, in tandem standing, standing on one leg and in walking. In each condition the perturbration is given every 5-15 seconds in different speed and in unexpected direction (right /left). Lost of balance control is any change in the original location of the foot in standing conditions or stepping out of the treadmill.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Physical education students from Zinman College in Wingate
Key inclusion criteria (3 listed)
- age 18-50
- good health
- active people
Key exclusion criteria (9 listed)
- 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
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
static balance control in reaction to perturbration
Time frame: 20 minutes
The angle velocity at the ankle at the moment of loosing postural control while standing
dynamic balance control un reaction to perturbration
Time frame: 10 minutes
the speed of perturbration at the moment of loosing balance while walking
1 secondary outcome
Time to returning to original condition
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Chronic Ankle Instability
Recruiting
Neurocognitive Enrichment During Functional Performance Testing in Chronic Ankle Instability
Chronic Ankle Instability, CAI
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Recruiting
Functional Biomechanical Analysis in Patients Who Underwent Lateral Ankle Ligament Repair With Augmentation
Chronic Lateral Ankle Instability
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Ankle Instability, run by Meir Medical Center.
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 9 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 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Alon Eliakim, MD (972-9-7471596, Eliakim.Alon@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
static balance control in reaction to perturbration (time frame: 20 minutes). 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 22 Nov 2019.