Foot-ankle exercises plus mindful walking for people with diabetic polyneuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with diabetic polyneuropathy and significant foot/ankle pain are enrolled and receive a 12-week intervention combining targeted foot-ankle therapeutic exercises with mindful walking, compared with usual-care conditions. Participants are assessed at baseline and after the intervention for pain (NPRS), foot-ankle disability, gait speed, range of motion, vibration sensitivity, and quality of life. The protocol requires independent walking ability for at least 10 m and excludes those with active plantar ulcers, major lower-limb surgery or orthopedic implants, other neurological diseases, or non-diabetic causes of neuropathy. Outcome changes over the 12 weeks will determine whether the combined program yields clinically meaningful improvements versus standard care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nishtar 2
  Multan, Punjab Province, Pakistan Recruiting

Study contacts

• Principal investigator: Fatima Tariq, MS — Riphah International University
• Study coordinator: Fatima Tariq, MS
• Email: fatima.tariq@rihah.edu.pk
• Phone: 923344255033

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.