Diabetic Peripheral NeuropathyNCT07100301
Effect of an Exercise Program on Motor Dysfunctions Caused by Diabetic Peripheral Neuropathy
A study testing Proximal/distal protocol and Distal protocol in people with Diabetic Peripheral Neuropathy, run by Federal University of Piaui.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Proximal/distal protocol and Distal protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of a Trunk, Hip, Knee, and Ankle Exercise Program on Motor Dysfunctions Caused by Diabetic Peripheral Neuropathy: a Randomized Clinical 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Proximal/distal protocol, Distal protocol
- Keywords
- Diabetic peripheral neuropathy, Biomechanic, Gait, Muscle strength, Kinematics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal/distal protocolOther
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.
Distal protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Proximal-distal group | Experimental | The experimental group will receive a proximal/distal exercise program (trunk, hip, knee and ankle). Receives: 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. Receives: Other: Distal protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Piaui
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinicius Saura Cardoso, Federal University of Piaui
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100301
- Sponsor's protocol ID
- 79226724.9.0000.0192
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Trunk, Hip, Knee, and Ankle Exercise Program on Motor Dysfunctions Caused by Diabetic Peripheral Neuropathy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07100301
- Acronym / sponsor ID
- 79226724.9.0000.0192
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Diabetic peripheral neuropathy, Biomechanic, Gait, Muscle strength, Kinematics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Federal University of PiauiUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal-distal group | Experimental | Other: Proximal/distal protocolThe experimental group will receive a proximal/distal exercise program (trunk, hip, knee and ankle). |
| Distal group | Active comparator | Other: Distal protocolThe control group will receive a distal exercise program (ankle and foot) available in the literature and previously tested. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proximal/distal protocolProximal/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 | Proximal-distal group |
| Distal protocolDistal 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. | Other | Distal group |
Primary outcome
Gait speed
Time frame: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).
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.
4 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetic Peripheral Neuropathy
Recruiting
Effects of Perturbation-Based Versus Conventional Balance Training on Reactive Stepping Ability in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Active, not recruiting
COMPARATIVE EFFECTS OF SENSORY REWEIGHTING AND PROPRIOCEPTIVE FACILITATION TRAINING ON BALANCE AND FALL RISK IN DIABETIC PERIPHERAL NEUROPATHY
Diabetic Peripheral Neuropathy (DPN)
Active, not recruiting
Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
Lower Extremity Amputee, Diabetic Peripheral Neuropathy
Not yet recruitingPhase 1
Placental Cells for Diabetic Foot Ulcers
Diabetic Foot Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal/distal protocol and Distal protocol in people with Diabetic Peripheral Neuropathy, run by Federal University of Piaui.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vinicius Saura Cardoso (+55 86 99984-2919, vscfisio@ufdpar.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (time frame: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.