Foot-ankle exercises plus mindful walking for people with diabetic polyneuropathy
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 trial will test whether adding a 12-week foot-ankle exercise program to mindful walking reduces foot/ankle pain and improves function and quality of life for adults (40–75) with diabetic polyneuropathy who can walk independently.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 40 Months to 75 Months |
| Sex | All |
| Sponsor | Riphah International University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Multan, Punjab Province) |
| Trial ID | NCT07248631 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 40–75 with clinician-confirmed diabetic polyneuropathy, foot/ankle pain rated ≥4 on the NPRS, independent walking ability of at least 10 m, and capacity to follow exercise instructions are ideal candidates.
Not a fit: People with active plantar ulcers or gangrene, those needing or having recent lower-limb arthroplasty or orthoses, other neurologic diseases, or neuropathy from non-diabetic causes are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, the combined program could reduce foot/ankle pain, improve mobility and foot function, and enhance quality of life for people with diabetic polyneuropathy.
How similar studies have performed: Prior 12-week foot-ankle exercise programs in diabetic neuropathy have shown improvements in gait speed, range of motion, vibration sensitivity, and quality of life, while evidence for mindful walking in chronic pain is mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Multan, Punjab Province
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.