Effect of an Exercise Program on Motor Dysfunctions Caused by Diabetic Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proximal/distal protocol, Distal protocol.
- Who it may be relevant to
- Registry conditions: Diabetic Peripheral Neuropathy. Basic parameters: 45 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of a Trunk, Hip, Knee, and Ankle Exercise Program on Motor Dysfunctions Caused by Diabetic Peripheral Neuropathy: a Randomized Clinical Trial
Overview
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.
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.
Primary outcome measures
- Gait speed [Time frame: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
Secondary outcome measures (4)
- Joint angles during gait [Time frame: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
- Step length and stride [Time frame: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
- Muscle strength [Time frame: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
- 30 second sit to stand test [Time frame: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07100301 · 79226724.9.0000.0192