Pilot Study to Develop Protocols for Recording Tibialis Posterior EMG (NCT06131359) | Clinical Trial Compass
UnknownNot Applicable
Pilot Study to Develop Protocols for Recording Tibialis Posterior EMG
30 participantsStarted 2023-12
Plain-language summary
This is an observational pilot study to allow us to create a normal database of muscle function of one of the muscles in the back of the leg (tibialis posterior). Individuals with no foot and ankle problems will be recruited to undergo 2 tests.
Firstly, under ultrasound guidance we will insert a very fine needle into the muscle which is deep inside the lower leg. The needle is similar to an acupuncture needle and is removed once it is in the muscle. This leave behind 2 very fine wires (the size of strand of hair) which we will use to assess the electrical activity of the muscle when walking.
Secondly, we will test muscle strength by asking individuals to push against the side of a special box, called a force frame). This will give us a link between the muscle activity and the strength of the muscle.
We plan to recruit 30 individuals, (15 in each age group), 20 of whom will undergo repeat testing on a separate day to ensure our protocol is repeatable.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults will be included for the younger group if 18-35 years of age and the older group over 55 years of age.
Exclusion Criteria:
* Any recent lower limb injury or foot or ankle pathology including hallux valgus and tibialis posterior tendon dysfunction.
* Any cardiovascular, musculoskeletal or neurological conditions or disease, immune deficiency or haemophilia.
* Taking anti- biotic medication, anti-coagulant medication, and anti -platelet therapy.
* Walk with an aid.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
EMG signal amplitude and time profile across the gait cycle when walking
Timeframe: Baseline (and repeat on different day within 1 month for subgroup)
2
Muscle strength
Timeframe: Baseline (and repeat on different day within 1 month for subgroup)
Trial details
NCT IDNCT06131359
SponsorRobert Jones and Agnes Hunt Orthopaedic and District NHS Trust