Tibialis Posterior DysfunctionNCT06131359
Pilot Study to Develop Protocols for Recording Tibialis Posterior EMG
An observational study of Tibialis Posterior Dysfunction and Emg, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tibialis Posterior Dysfunction, Emg
- What is being tested?
- Fine wire EMG and Force Frame muscle strength testing
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Apr 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Typically developing adult subjects
Who may be able to join
- Adults will be included for the younger group if 18-35 years of age and the older group over 55 years of age.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilot Study to Develop Protocols for Recording Electromyography Signals From Tibialis Posterior and Demonstrate Age-related Changes in Muscle Activity Which May be Linked to Tibialis Posterior Tendon Dysfunction (TPTD)
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.
Read more
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.
Read the detailed description
Tibialis posterior (TP), plays a substantial role in supporting the arch of the foot. Tibialis posterior tendon dysfunction (TPTD) involves pain and swelling on the inner side of the foot and often leads to an acquired flat foot deformity. However, there is also a tendency for foot width to increase and arch height to decrease with age. Greater concurrent activation of muscles that perform opposing movements has been shown with age. However it is unknown whether greater co-activation of TP and its opposing peroneal muscles increase with age. There is uncertainty regarding the management of TPTD, recently highlighted by the James Lind Alliance as a research priority.
To improve understanding of TP function we can study the electrical signal when TP activates using electromyography (EMG). Foot arch height has been shown to influence the pattern of TP activation in young-middle aged adults during walking. However, to enable comparisons between groups of participants (e.g. young vs. old, or patients vs. healthy controls) it is necessary to perform a normalization process to account for individual differences e.g. in orientation of muscle fibres. Recent expert consensus advocated normalising to a maximum voluntary contraction (MVC) when comparing groups. Previous studies have reported poor between-day reliability of TP EMG when normalising to an MVC. In the latter studies, the MVC contraction was performed against manual resistance, potentially reducing the reliability of the measurement due to variability in the resistance from the tester. Reliability of the MVC may be improved by using a controlled means of providing resistance to muscle contraction such as an isokinetic dynamometer, or a ForceFrame (VALD Health). Establishing a reliable method to record EMG from TP will enable future work investigating the mechanisms leading to TPTD and explore the potential for EMG to tailor treatment plans.
Due to the depth of TP, it is necessary to use fine-wire electrodes, inserted under the skin to record EMG. Fine-wire insertions will be performed by trained co-worker Dr Jo Reeves using ultrasound guidance and verified with electrical stimulation. Surface sensors will be placed on additional muscles (peroneals, tibialis anterior and gastrocnemii). With the electrodes in place the participants will lie on their backs and perform three maximum contractions of ankle inversion against resistance. The EMG signal from the contraction with the highest force value will be used to normalise subsequent EMG during walking. Participants will perform six walks on a standard walkway.
A target of 30 participants will be recruited (15 younger adults and 15 older adults). A subset of 20 participants will repeat the above procedure in a second session, separated by at least a day. Previous work on the between-day reliability of EMG recording from soleus during walking demonstrated comparable reliability using fine-wire electrodes to surface electrodes with 18 participants (Bogey et al., 2003). Reliability will be established with the standard error of measurement, the coefficient of variation, the intra-class correlation coefficient and the coefficient of multiple correlation.
- Conditions
- Tibialis Posterior Dysfunction, Emg
- Being tested
- Fine wire EMG and Force Frame muscle strength testing
- Keywords
- tibialis posterior, EMG, gait lab
- Medical subject headings
- Posterior Tibial Tendon Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine wire EMG and Force Frame muscle strength testingDiagnostic test
Insertion of fine wires for EMG study of tibialis posterior and assessment of muscle strength using a force frame
| Study group | Role | What they receive |
|---|---|---|
| Younger adults | age 18-35 years Receives: Diagnostic Test: Fine wire EMG and Force Frame muscle strength testing | |
| Older adults | age over 55 years Receives: Diagnostic Test: Fine wire EMG and Force Frame muscle strength testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG signal amplitude and time profile across the gait cycle when walking
Using fine wire
Measured: Baseline (and repeat on different day within 1 month for subgroup)
Muscle strength
Using force frame
Measured: Baseline (and repeat on different day within 1 month for subgroup)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibialis Posterior DysfunctionStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Exeter
- Responsible party
- Sponsor
- Investigators
- Catriona Heaver, Study chair, RJAHCaroline Stewart, Principal investigator, RJAHJo Reeves, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131359
- Sponsor's protocol ID
- RL1880
- Status last verified
- Nov 2023
- First submitted
- 9 Aug 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Develop Protocols for Recording Electromyography Signals From Tibialis Posterior and Demonstrate Age-related Changes in Muscle Activity Which May be Linked to Tibialis Posterior Tendon Dysfunction (TPTD)
- ClinicalTrials.gov ID
- NCT06131359
- Acronym / sponsor ID
- RL1880
- Conditions
- Tibialis Posterior Dysfunction, Emg
- Keywords
- tibialis posterior, EMG, gait lab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Collaborators
- University of Exeter
- Study start
- Dec 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 14 Nov 2023 (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.
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.
Detailed description
Tibialis posterior (TP), plays a substantial role in supporting the arch of the foot. Tibialis posterior tendon dysfunction (TPTD) involves pain and swelling on the inner side of the foot and often leads to an acquired flat foot deformity. However, there is also a tendency for foot width to increase and arch height to decrease with age. Greater concurrent activation of muscles that perform opposing movements has been shown with age. However it is unknown whether greater co-activation of TP and its opposing peroneal muscles increase with age. There is uncertainty regarding the management of TPTD, recently highlighted by the James Lind Alliance as a research priority.
To improve understanding of TP function we can study the electrical signal when TP activates using electromyography (EMG). Foot arch height has been shown to influence the pattern of TP activation in young-middle aged adults during walking. However, to enable comparisons between groups of participants (e.g. young vs. old, or patients vs. healthy controls) it is necessary to perform a normalization process to account for individual differences e.g. in orientation of muscle fibres. Recent expert consensus advocated normalising to a maximum voluntary contraction (MVC) when comparing groups. Previous studies have reported poor between-day reliability of TP EMG when normalising to an MVC. In the latter studies, the MVC contraction was performed against manual resistance, potentially reducing the reliability of the measurement due to variability in the resistance from the tester. Reliability of the MVC may be improved by using a controlled means of providing resistance to muscle contraction such as an isokinetic dynamometer, or a ForceFrame (VALD Health). Establishing a reliable method to record EMG from TP will enable future work investigating the mechanisms leading to TPTD and explore the potential for EMG to tailor treatment plans.
Due to the depth of TP, it is necessary to use fine-wire electrodes, inserted under the skin to record EMG. Fine-wire insertions will be performed by trained co-worker Dr Jo Reeves using ultrasound guidance and verified with electrical stimulation. Surface sensors will be placed on additional muscles (peroneals, tibialis anterior and gastrocnemii). With the electrodes in place the participants will lie on their backs and perform three maximum contractions of ankle inversion against resistance. The EMG signal from the contraction with the highest force value will be used to normalise subsequent EMG during walking. Participants will perform six walks on a standard walkway.
A target of 30 participants will be recruited (15 younger adults and 15 older adults). A subset of 20 participants will repeat the above procedure in a second session, separated by at least a day. Previous work on the between-day reliability of EMG recording from soleus during walking demonstrated comparable reliability using fine-wire electrodes to surface electrodes with 18 participants (Bogey et al., 2003). Reliability will be established with the standard error of measurement, the coefficient of variation, the intra-class correlation coefficient and the coefficient of multiple correlation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Younger adults | – | Diagnostic Test: Fine wire EMG and Force Frame muscle strength testingage 18-35 years |
| Older adults | – | Diagnostic Test: Fine wire EMG and Force Frame muscle strength testingage over 55 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Typically developing adult subjects
Key inclusion criteria (1 listed)
- Adults will be included for the younger group if 18-35 years of age and the older group over 55 years of age.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Fine wire EMG and Force Frame muscle strength testingInsertion of fine wires for EMG study of tibialis posterior and assessment of muscle strength using a force frame | Diagnostic test | Older adults, Younger adults |
Primary outcome
EMG signal amplitude and time profile across the gait cycle when walking
Time frame: Baseline (and repeat on different day within 1 month for subgroup)
Using fine wire
Muscle strength
Time frame: Baseline (and repeat on different day within 1 month for subgroup)
Using force frame
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
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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.
Catriona Heaver study chair
RJAH
Caroline Stewart principal investigator
RJAH
Jo Reeves principal investigator
University of Exeter
Questions about this trial
What is this clinical trial studying?
An observational study of Tibialis Posterior Dysfunction and Emg, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catriona Heaver (01691 404573, catriona.heaver@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG signal amplitude and time profile across the gait cycle when walking (time frame: Baseline (and repeat on different day within 1 month for subgroup)). The study lists 2 primary outcomes in all. 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 14 Nov 2023.