Effect of Stretching on Visco-elastic Behaviour of the Fa... | NCT05153993

Studies
Effect of Stretching on Visco-elastic Behaviour of the Fascia Plantaris in a Healthy Population

NCT05153993

Sponsor

University Ghent

Status

Completed

Last Update Posted

Dec 10, 2021Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Fasciitis, Plantar
Stretch
Rehabilitation
Stiffness of Unspecified Foot, Not Elsewhere Classified

Interventions

Fascia stretch

Countries

Belgium

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 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Dec 20, 2017Actual

Completion Date

May 5, 2018Actual

First Submitted Date

Jul 4, 2018

First Submission Date that Met QC Criteria

Nov 29, 2021

First Posted Date

Dec 10, 2021Actual

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 29, 2021

Last Update Posted Date

Dec 10, 2021Actual

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

RCT with two arms: (1) stretch fascia plantaris (6 weeks, n=30) (2) control (n=30); Outcome parameters: ROM ankle and first toe; visco-elastic behaviour of the fascia plantaris determined by means of myotonometry Study protocol: Outcome parameters were evaluated before and after the intervention/control with a 6 weeks interval. All participants were screened bilaterally and for the participants assigned to the intervention group stretching was only performed on the dominant side

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stretch fascia plantaris	Experimental		Other: Fascia stretch
Control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fascia stretch	Other	Stretch of the fascia plantaris during 3x30", 5x/week, 6 weeks	Stretch fascia plantaris

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visco-elastic behaviour using myotonometry	By means of the MyotonPro device	within 20 minutes before and after intervention

Secondary Outcomes

Measure	Description	Time Frame
Range of Motion of ankle joint and first metatarsalphalangeal joint	By means of goniometry	within 20 minutes before and after intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers

Exclusion Criteria:

Lower extremity injury

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roel De Ridder	University Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Roel De Ridder		Ghent	East Flanders	9000	Belgium

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

Condition Browse Module

MeSH Terms

ID	Term
D036981	Fasciitis, Plantar

Ancestor Terms

ID	Term
D005208	Fasciitis
D009140	Musculoskeletal Diseases
D005534	Foot Diseases

Browse Leaves

Not provided

Browse Branches

Not provided