Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proximal-distal group | Experimental | The experimental group will receive a proximal/distal exercise program (trunk, hip, knee and ankle). |
|
| Distal group | Active Comparator | The control group will receive a distal exercise program (ankle and foot) available in the literature and previously tested. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Joint angles during gait | Using adhesive markers placed on points of the right lower limb (greater trochanter, lateral epicondyle of the femur, lateral malleolus, and head of the fifth metatarsal), the angles of maximum hip flexion and extension, maximum knee flexion and extension, and maximum ankle dorsiflexion and plantar flexion will be measured from the lateral view of the right lower limb using the CvMob program. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vinicius Saura Cardoso | Contact | +55 86 99984-2919 | vscfisio@ufdpar.edu.br |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Blinding will be single-blind, so the outcome evaluator will not be aware of the allocation of participants to the groups.
|
| 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. |
|
| Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3). |
| Step length and stride | Using the CvMob program, stride length (cm) will be measured, which corresponds to the distance between the markers positioned on the calcaneus of the right and left feet after consecutive foot contact. Stride length will be determined by the distance in centimeters from the calcaneus marker between the first and second initial contact of the right lower limb. | Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3). |
| Muscle strength | The assessment of lower limb (dominant limb) and trunk muscle strength will be performed using dynamometry. Three attempts will be performed with a minimum one-minute interval between them to avoid any fatigue effects. The highest value among the three attempts will be used as the dependent variable. The muscle groups tested will be: ankle dorsiflexors and plantar flexors, knee extensors, hip abductors, and trunk extensors. | Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3). |
| 30 second sit to stand test | The 30-second sit-to-stand test (30STS) is a validated test for assessing lower limb muscle strength in older adults. The patient will be asked to sit and stand in a standard-height chair (46-48 centimeters) positioned against a wall. The knees and hips should be flexed at 90 degrees, the feet flat on the floor and hip-width apart, the hands resting on the hips, and no support will be used. For 30 seconds, the participant must repeatedly sit and stand up from the chair as quickly as possible. The count will begin in the sitting position and end when the participant reaches the final standing position. The number of repetitions will be counted and recorded. | Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3). |