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

Federal University of Piaui

Status: Not yet enrolling

Conditions: Diabetic Peripheral Neuropathy

Treatments: Other: Proximal/distal protocol; Other: Distal protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT07100301

79226724.9.0000.0192

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Absence of diabetic foot ulcer (DFU) for at least one month
• No amputation or at most amputation of fingers, except for the hallux

Exclusion criteria

• 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
• Diagnosis of other neurological impairments in addition to DPN
• Presence of dementia or inability to provide consistent information
• Severe retinopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Proximal-distal group

Experimental group

Description:

The experimental group will receive a proximal/distal exercise program (trunk, hip, knee and ankle).

Treatment:

Other: Proximal/distal protocol

Distal group

Active Comparator group

Description:

The control group will receive a distal exercise program (ankle and foot) available in the literature and previously tested.

Treatment:

Other: Distal protocol