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

NCT07100301 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-08-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Federal University of Piaui

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2027-08-31
Completion
2028-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100301 on ClinicalTrials.gov