CompletedNot Applicable

Effects of Foot Muscle Strengthening in Daily Activity in Diabetic Neuropathic Patients

Brazil78 participantsStarted 2016-08

Plain-language summary

The main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.

Who can participate

Age range

18 Years – 75 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: * Diabetes mellitus type 1 or 2 * Moderate or severe polyneuropathy confirmed with the fuzzy software * Ability to walk independently in the laboratory * Accessibility to electronic devices * Loss of at least 4 degrees of ankle range of motion * Loss of at least 1 degree of force in the clinical scale of the plantar interosseous or lumbrical muscles Exclusion Criteria: * Ulceration not healed for at least 6 months * Hallux amputation or total amputation of the foot * Receiving any physiotherapy intervention or offloading devices * Neurological or orthopedic impairments * Major vascular complications * Severe retinopathy

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

Daily Physical Activity

Timeframe: 12 weeks

Self Selected Gait Speed

Timeframe: 12 weeks

Fast Gait Speed

Timeframe: 12 weeks

Trial details

NCT IDNCT02790931

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

Results submitted2022-11-09

View on ClinicalTrials.gov More Diabetic Neuropathies trials

Who can participate

Age range

18 Years – 75 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.