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

NCT07100301 | Not Yet Recruiting DMC

• 1 other identifier: 79226724.9.0000.0192
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Diabetic peripheral neuropathy; Biomechanic; Gait; Muscle strength; Kinematics

Outcome Measures

Primary Outcomes (1)

• Gait speed

  Adhesive markers will be placed at the following points on the right lower limb: greater trochanter, lateral epicondyle of the femur, lateral malleolus, and head of the fifth metatarsal. Markers will also be placed on the calcaneus of both feet. The participant will walk on a nine-meter track for filming with a digital camera. The CvMob program will be used to analyze self-selected gait speed and fast gait. Speed in m/s will be calculated based on the time it takes the participant to traverse a three-meter distance marked on the track.

  Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).

Secondary Outcomes (4)

• Joint angles during gait

  Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).

• Step length and stride

  Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).

• Muscle strength

  Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).

• 30 second sit to stand test

  Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).

Study Arms (2)

Proximal-distal group

EXPERIMENTAL

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

Other: Proximal/distal protocol

Distal group

ACTIVE COMPARATOR

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

Other: Distal protocol

Interventions

Proximal/distal protocol OTHER

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.

Proximal-distal group

Distal protocol OTHER

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.

Distal group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Piaui: lead

Central Study Contacts

Vinicius Saura Cardoso

CONTACT

+55 86 99984-2919; vscfisio@ufdpar.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding will be single-blind, so the outcome evaluator will not be aware of the allocation of participants to the groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 3, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share