NCT05153993

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2018

Completed
3.4 years until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
Last Updated

December 10, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

July 4, 2018

Last Update Submit

November 29, 2021

Conditions

Fasciitis, PlantarStretchRehabilitationStiffness of Unspecified Foot, Not Elsewhere Classified

Outcome Measures

Primary Outcomes (1)

  • Visco-elastic behaviour using myotonometry

    By means of the MyotonPro device

    within 20 minutes before and after intervention

Secondary Outcomes (1)

  • Range of Motion of ankle joint and first metatarsalphalangeal joint

    within 20 minutes before and after intervention

Study Arms (2)

Stretch fascia plantaris

EXPERIMENTAL
Other: Fascia stretch

Control group

NO INTERVENTION

Interventions

Fascia stretchOTHER

Stretch of the fascia plantaris during 3x30", 5x/week, 6 weeks

Stretch fascia plantaris

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • Lower extremity injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roel De Ridder

Ghent, East Flanders, 9000, Belgium

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Study Officials

  • Roel De Ridder

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2018

First Posted

December 10, 2021

Study Start

October 1, 2017

Primary Completion

December 20, 2017

Study Completion

May 5, 2018

Last Updated

December 10, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)