Fasciitis, PlantarNCT05153993
Effect of Stretching on Visco-elastic Behaviour of the Fascia Plantaris in a Healthy Population
A study testing Fascia stretch in people with Fasciitis, Plantar and Stretch, run by University Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fasciitis, Plantar, Stretch, Rehabilitation
- What is being tested?
- Fascia stretch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2017to 5 May 2018
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy volunteers
Who cannot join
- Lower extremity injury
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Fasciitis, Plantar, Stretch, Rehabilitation, Stiffness of Unspecified Foot, Not Elsewhere Classified
- Being tested
- Fascia stretch
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia stretchOther
Stretch of the fascia plantaris during 3x30", 5x/week, 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Stretch fascia plantaris | Experimental | Not described Receives: Other: Fascia stretch |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visco-elastic behaviour using myotonometry
By means of the MyotonPro device
Measured: within 20 minutes before and after intervention
Secondary outcomes (1)
Range of Motion of ankle joint and first metatarsalphalangeal joint
By means of goniometry
Measured: within 20 minutes before and after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start1 Oct 2017
- Primary completion20 Dec 2017
- Study completion5 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasciitis, PlantarStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roel De Ridder, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153993
- Sponsor's protocol ID
- 2017/1215
- Status last verified
- Nov 2021
- First submitted
- 4 Jul 2018
- Last updated
- 10 Dec 2021
- 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 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stretching on Visco-elastic Behaviour of the Fascia Plantaris in a Healthy Population
- ClinicalTrials.gov ID
- NCT05153993
- Acronym / sponsor ID
- 2017/1215
- Conditions
- Fasciitis, Plantar, Stretch, Rehabilitation, Stiffness of Unspecified Foot, Not Elsewhere Classified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 5 May 2018 (actual)
- First posted
- 10 Dec 2021 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretch fascia plantaris | Experimental | Other: Fascia stretch |
| Control group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (1 listed)
- Lower extremity injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fascia stretchStretch of the fascia plantaris during 3x30", 5x/week, 6 weeks | Other | Stretch fascia plantaris |
Primary outcome
Visco-elastic behaviour using myotonometry
Time frame: within 20 minutes before and after intervention
By means of the MyotonPro device
1 secondary outcome
Range of Motion of ankle joint and first metatarsalphalangeal joint
Time frame: within 20 minutes before and after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Roel De Ridder principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascia stretch in people with Fasciitis, Plantar and Stretch, run by University Ghent at 1 site in Belgium.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visco-elastic behaviour using myotonometry (time frame: within 20 minutes before and after intervention). 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 10 Dec 2021.