Effects of multi-segmental therapeutic exercises on gait spatiotemporal parameters and lower-limb kinematics in individuals with diabetic peripheral neuropathy: A randomized clinical trial protocol

BACKGROUND: Diabetic peripheral neuropathy (DPN) impairs gait and increases fall risk. Current exercise programs mainly target distal segments, potentially neglecting proximal contributions to locomotor control. OBJECTIVE: To compare the effects of a multi-segmental therapeutic exercise program versus an ankle-foot focused program on gait biomechanics in individuals with DPN. DESIGN: Assessor-blinded randomized controlled trial. METHODS: Sixty-four adults with DPN will be randomized to either a multi-segmental group (trunk, hip, knee and ankle exercises) or an ankle-foot group. Both groups will train twice weekly for 12 weeks. The primary outcome will be self-selected gait speed. Secondary outcomes include kinematic gait parameters, step and stride length, lower-limb muscle strength, 30-s sit-to-stand test and the quality of life. Assessments will occur at baseline, post-intervention and 4-week follow-up. Data will be analyzed using linear mixed models according to the intention-to-treat principle. HYPOTHESIS: The multi-segmental program will produce greater improvements in gait speed and functional performance. ETHICS: Approved by ethics committee and registered at ClinicalTrials.gov. Expected impact: Findings may support a shift from segmental to kinetic-chain-based rehabilitation in DPN.