NCT07100301

Effect of an Exercise Program on Motor Dysfunctions Caused by Diabetic Peripheral Neuropathy

Effect of a Trunk, Hip, Knee, and Ankle Exercise Program on Motor Dysfunctions Caused by Diabetic Peripheral Neuropathy: a Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Federal University of Piaui · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Diabetic Peripheral Neuropathy (DPN) affects approximately half of people with Diabetes Mellitus (DM). Its repercussions on the musculoskeletal system and biomechanics mainly impact balance and locomotor function. Therefore, this study is justified by the need to design effective treatment alternatives for the motor alterations observed in people with DPN. The objective of this study will be to evaluate the effectiveness of an exercise program for the trunk, hip, knee and ankle, consisting of muscle strengthening and sensorimotor training, in the treatment of motor deficits caused by DPN. This will be a single-blind randomized clinical trial in which 64 individuals with type 2 DM and DPN will be randomly distributed between the experimental and control groups. The primary outcome will be the kinematic analysis of gait. The secondary outcomes will be: muscle strength assessed by dynamometry and the 30-second sit-to-stand test (30STS), and functional mobility through the Timed Up and Go (TUG) test. Assessments will be performed before the start of the intervention, at the end of the intervention, and at the one-month follow-up. The experimental group will perform a 12-week proximal/distal exercise program (trunk, hip, knee, and ankle). The control group will perform a distal exercise program (ankle and foot). The proposed exercise program is expected to show consistently positive results compared to the control group.

Conditions

• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
OTHER	Proximal/distal protocol	Proximal/distal exercise program (trunk, hip, knee and ankle) consisting of four stages: warm-up, strengthening, sensorimotor training and relaxation. The intervention will last 12 weeks and will take place twice a week, with an average duration of 50-60 minutes.
OTHER	Distal protocol	Distal exercise program available in the literature and previously tested. This will contain warm-up exercises, intrinsic foot muscle strengthening, extrinsic foot-ankle muscle strengthening, and functional exercises. The intervention will last 12 weeks and will take place twice a week, with an average duration of 50-60 minutes.

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-08-01
• Completion: 2028-08-01
• First posted: 2025-08-03
• Last updated: 2025-08-03