The Effect of Perturbration on Balance Control in Adults | NCT04174027

Studies
The Effect of Perturbration on Balance Control in Adults

NCT04174027

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Nov 22, 2019Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Chronic Ankle Instability

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2019Estimated

Primary Completion Date

Oct 15, 2020Estimated

Completion Date

Dec 15, 2020Estimated

First Submitted Date

Oct 3, 2019

First Submission Date that Met QC Criteria

Nov 20, 2019

First Posted Date

Nov 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2019

Last Update Posted Date

Nov 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	30 minutes

Other Outcomes

Measure	Description	Time Frame
movement inside the foot during balance control.	The changes in center of pressure (COP) amplitude height	30 minutes

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Physical education students from Zinman College in Wingate

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alon Eliakim, MD	Contact	972-9-7471596		Eliakim.Alon@clalit.org.il
Michal Pantanowitz, PhD	Contact	972-9-7471596		michal.pantanowitz@clalit.org.il

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided