Pilot Study to Develop Protocols for Recording Tibialis Posterior EMG

NCT06131359 | Unknown

• 1 other identifier: RL1880
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tibialis Posterior Dysfunction; Emg

Keywords

tibialis posterior; EMG; gait lab

Outcome Measures

Primary Outcomes (2)

• EMG signal amplitude and time profile across the gait cycle when walking

  Using fine wire

  Baseline (and repeat on different day within 1 month for subgroup)

• Muscle strength

  Using force frame

  Baseline (and repeat on different day within 1 month for subgroup)

Study Arms (2)

Younger adults

age 18-35 years

Diagnostic Test: Fine wire EMG and Force Frame muscle strength testing

Older adults

age over 55 years

Diagnostic Test: Fine wire EMG and Force Frame muscle strength testing

Interventions

Fine wire EMG and Force Frame muscle strength testing DIAGNOSTIC_TEST

Insertion of fine wires for EMG study of tibialis posterior and assessment of muscle strength using a force frame

Older adults; Younger adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Typically developing adult subjects

You may qualify if:

• Adults will be included for the younger group if 18-35 years of age and the older group over 55 years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust: lead
• University of Exeter: collaborator

MeSH Terms

Conditions

Posterior Tibial Tendon Dysfunction

Condition Hierarchy (Ancestors)

Foot Diseases; Musculoskeletal Diseases

Study Officials

• Catriona Heaver

  RJAH

  STUDY CHAIR

• Caroline Stewart

  RJAH

  PRINCIPAL INVESTIGATOR

• Jo Reeves

  University of Exeter

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catriona Heaver

CONTACT

01691 404573; catriona.heaver@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: November 14, 2023
• Study Start: December 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11