Plantar intrinsic muscle exercises versus three-dimensional ankle–foot exercises for people with diabetic peripheral neuropathy

Comparative Effects of Plantar Intrinsic Muscles Exercises and 3-dimensional Ankle Foot Exercises on Balance, Gait and Fall Risk in Patients With Diabetic Peripheral Neuropathy

This trial will test whether exercises that target the small muscles in the foot or three-dimensional ankle–foot exercises better improve balance, walking, and lower the risk of falls in people aged 50–75 with diabetic peripheral neuropathy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 50 Years to 75 Years
• Sex: All
• Sponsor: Riphah International University (other)
• Locations: 1 site (Sargodha, Punjab Province)
• Trial ID: NCT07576179 on ClinicalTrials.gov

What this trial studies

This is a single-blinded, randomized clinical trial that will enroll 40 patients with diabetic peripheral neuropathy and randomly assign them to either plantar intrinsic foot muscle exercises or three-dimensional ankle–foot exercises. Each group will follow a targeted exercise program and undergo outcome measurements of balance, gait, and fall risk before and after the intervention. Participants must be able to walk 10 m barefoot, have an abnormal Michigan Neuropathy Screening Instrument score, and normal cognitive screening. The trial will be conducted at Dr. Faisal Masood Teaching Hospital in Sargodha using convenience sampling and computerized random allocation.

Who should consider this trial

Good fit: Ideal candidates are adults 50–75 years old with diabetic peripheral neuropathy (MNSI ≥ 7), able to ambulate 10 m barefoot, with a history of fear of falling or a fall in the past year and normal cognitive function (MMSE > 25).

Not a fit: Patients with other neurological disorders, active plantar ulcers, severe retinopathy, limited ankle/foot range of motion, recent lower-limb surgery or injury, significant musculoskeletal conditions affecting gait, or those already in concurrent rehabilitation are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the findings could guide simple, targeted exercise programs to improve balance and reduce falls in people with diabetic neuropathy.

How similar studies have performed: Previous smaller rehabilitation studies have shown that foot-strengthening and ankle-mobility exercises can improve balance and gait in people with diabetic neuropathy, though direct head-to-head comparisons of these two specific approaches are limited.

Eligibility criteria

Inclusion Criteria:

* The participants who scored ≥ 7 (abnormal) as per the Michigan Neuropathy Screening Instrument (MNSI)
* Able to ambulate 10 m barefoot without using a walking aid
* Patient reporting to have either fear of falling or experienced a fall in the previous 12 months
* Cognitive Function on Mini-Mental State Examination is normal (MMSE score: Above 25)
* Patients having difficulties with mobility, gait, or balance in daily life

Exclusion Criteria:

* Presence of other neurological conditions (GBS, Paraneoplastic Neuropathy, Infectious Neuropathy, others)
* Severe Retinopathy, a vascular complication of DM.
* Limited Ankle and foot ROM due to fracture or contracture.
* Presence of active plantar ulcers.
* Recent surgeries or injuries in the foot/lower limb.
* Musculoskeletal disorders affecting gait (Osteoarthritis, Rheumatoid arthritis, Muscular dystrophy, Hip dysplasia, others)
* Participation in another rehabilitation or training concurrently

Where this trial is running

Sargodha, Punjab Province

• Dr. Faisal Masood Teaching Hospital, Sargodha — Sargodha, Punjab Province, Pakistan (RECRUITING)

Study contacts

• Principal investigator: Hira Jabeen, MS-PT — Riphah International University
• Study coordinator: Imran Amjad, Phd

Conditions: Diabetic Peripheral Neuropathy, Diabetic peripheral neuropathy, balance, gait, Plantar intrinsic muscle exercises, Three-Dimensional ankle foot exercises