Child DevelopmentNCT05862246
Gastrocnemius Tightness and Foot Pain in Children
An observational study of Child Development and Gastrocnemius Equinus, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Foot and leg pain among otherwise healthy children is a common reason for referral to our pediatric orthopaedics outpatient clinic. The pain is often intermittent and transient, but for some the pain is more dominating and has an impact on the child and families. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Child Development, Gastrocnemius Equinus
- What is being tested?
- Clinical examination
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 9 May 2023to Jun 2028
- Phase
- Observational
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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children referred to pediatric orthopaedic outpatients clinic from a family doctor
Who may be able to join
- Otherwise healthy children referred to pediatric orthopaedic outpatient clinic with foot and/or leg pain with a normal leg function
Who cannot join
- Patients with foot conditions, general medical conditions affecting the foot or clinical findings indicating a need for further investigation for a diagnosis. Such as:
- Foot deformities (cavo-varus foot, clubfoot) Tarsal coalitions Neuro-orthopedic conditions (CP, MMC) Fracture sequelae Infections and tumour
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
St Olavs hospital
Trondheim
Suki Liyanarachi, +4772821126, suki.liyanarachi@stolav.no
About this study
Official title: Is There an Association Between Gastrocnemius Tightness and Foot- and Legpain in Children?
Foot and leg pain among otherwise healthy children is a common reason for referral to our pediatric orthopaedics outpatient clinic. The pain is often intermittent and transient, but for some the pain is more dominating and has an impact on the child and families. Children grown and have normal anatomical variations such as in-toeing, out-toeing, hypermobility, flatfeet, knock knees etc. Assessing such normal variants is a major part of pediatric orthopaedic practice, and a common finding is a positive Silvferskiöld test, indicating gastrocnemius tightness. This is when dorsiflexion of the ankle is limited with extended knee, compared to flexed knee. We do not know if this is a more frequent finding among children with foot and leg pain. There is however evidence that adults with painful foot conditions often have gastrocnemius tightness.
This project will investigate for gastrocnemius tightness in otherwise healthy children referred to our pediatric orthopaedic outpatient clinic with foot and leg pain, and compare results with a similar control group of children without pain. The aim is to investigate if there is an association, and how pain and tightness develops over time. The knowledge from this project will enable us to develop new treatment strategies to this patient group, where current evidence based recommendations are few.
- Conditions
- Child Development, Gastrocnemius Equinus
- Being tested
- Clinical examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examinationOther
No intervention, only clinical examination
| Study group | Role | What they receive |
|---|---|---|
| Children with pain | These are children referred with fot and leg pain. Following outcomes will be measured on all included children:
Silvferskiölds test Height Weight Gender Age PROM child: Oxford Ankle and Foot Questionnaire for children PROM parent: Oxford Ankle and Foot Questionnaire for parents FPS pain scoring over 1 week Receives: Other: Clinical examination | |
| Control group children without pain | Following outcomes will be measured on all included children in control group:
Silvferskiölds test Height Weight Gender Age Receives: Other: Clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Silvferskiölds test
Clinical measurement of gastrocnemius tightness
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start9 May 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan Normal University
- Responsible party
- Sponsor
- Investigators
- Håkon Langvatn, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862246
- Sponsor's protocol ID
- 526706
- Status last verified
- Jul 2026
- First submitted
- 8 May 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No