- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04174027
The Effect of Perturbration on Balance Control in Adults
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Alon Eliakim, MD
- Phone Number: 972-9-7471596
- Email: Eliakim.Alon@clalit.org.il
Study Contact Backup
- Name: Michal Pantanowitz, PhD
- Phone Number: 972-9-7471596
- Email: michal.pantanowitz@clalit.org.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age 18-50
- good health
- active people
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
20 minutes
|
dynamic balance control un reaction to perturbration
Time Frame: 10 minutes
|
the speed of perturbration at the moment of loosing balance while walking
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to returning to original condition
Time Frame: 30 minutes
|
How much time it takes to come back to the original step (Center of Pressure - COP) after the perturbration
|
30 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
movement inside the foot during balance control.
Time Frame: 30 minutes
|
The changes in center of pressure (COP) amplitude height
|
30 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MeirMc102-19CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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