Combined Effects of Foot-Ankle Therapeutic Exercises and Mindful Walking in Patients With Diabeti… (NCT07248631) | Clinical Trial Compass
RecruitingNot Applicable
Combined Effects of Foot-Ankle Therapeutic Exercises and Mindful Walking in Patients With Diabetic Polyneuropathy
Pakistan38 participantsStarted 2024-10-17
Plain-language summary
The aim of this study is to investigate the combined effects of foot ankle therapeutic exercises and mindful walking on pain, foot and ankle disability, and quality of life in patients with diabetic polyneuropathy. This study seeks to evaluate the efficacy of these interventions in improving clinical outcomes and enhancing the overall well-being of individuals with diabetic polyneuropathy.
Who can participate
Age range
40 Months – 75 Months
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:
* Diagnosed with diabetic polyneuropathy (DPN) confirmed by medical history and clinical examination.
* Experience pain and disability in foot/ankle, with a Numeric Pain Rating Scale (NPRS) score ≥ 4.
* Independent walking ability for at least 10 m.
* Age (40-75) years.
* Ability to understand and follow exercise instructions.
* A maximum of one amputated toe, not being the hallux.
* Willingness to participate in the study and provide informed consent.
Exclusion Criteria:
* Presence of an active plantar ulcer or gangrene.
* History of surgical procedure at the knee, ankle, or hip or indication of surgery throughout the intervention period.
* Arthroplasty and/or orthosis of lower limbs or indication of lower limb arthroplasty throughout the intervention period.
* Participating in other exercise programs or studies.
* Dementia or inability to give consistent information.
* Diagnosis of neurological diseases.
* Neuropathic pain due to other causes (e.g., HIV, chemotherapy).
* Major vascular complications and/or 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.