About this trial
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.
Eligibility criteria
Qualifiers
Adult individuals aged between 45 and 75 years, male or female, diagnosed with DM2
DPN diagnosis based on vibration sensitivity tests assessed by a 128 Hz tuning fork and tactile sensitivity measured by a 10 g monofilament
Sedentary or irregularly active individuals (level A) according to the Physical Activity Level Classification - IPAQ
Score of at least 5 points on the Functional Independence Measure (FIM), i.e., requires supervision, but without physical contact
Disqualifiers
Individuals involved in physical training programs simultaneously with the intervention
History of surgical intervention in the lower limbs or spine
Use of walking assistance devices
Diagnosis of severe cardiovascular disorder
Trial design
Treatments tested in this trial
- Proximal/distal protocol
- Distal protocol