Diabetic NeuropathiesFOCA-IINCT04008745
Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment in People With Diabetic Neuropathy
A study testing Educational and home-based physical therapy by foot-related exercises in people with Diabetic Neuropathies, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The main objective of this trial is to investigate the effect of an educational booklet foot-related exercise in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Educational and home-based physical therapy by foot-related exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2019to 26 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus type 1 or 2;
- Moderate or severe neuropathy confirmed with the fuzzy software;
- Ability to walk independently in the laboratory
Who cannot join
- Hallux amputation or total amputation of the foot;
- History of surgical procedure in the knee, ankle or hip;
- History of arthroplasty and / or lower limb orthosis or indication of lower limb arthroplasty throughout the intervention period;
- Neurological and / or rheumatologic diseases diagnosed;
- Inability to provide consistent information;
- Perform physiotherapy intervention throughout the intervention period;
Show all 11Show fewer
- Receiving any physiotherapy intervention or offloading devices;
- Major vascular complications;
- Severe retinopathy;
- Ulceration not healed for at least 6 months and / or active ulcer;
- Score between 12-21 (Probable Depression) from the Hospital Anxiety and Depression Scale (HADS).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-II) Randomized Controlled Trial
The main objective of this trial is to investigate the effect of an educational booklet foot-related exercise in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy.
Read the detailed description
A randomized controlled trial will be performed with 48 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group that will perform exercises at home, three times a week, through the booklet for 8-weeks.
The subjects will be evaluated in 3 different times to access the effect of the intervention: baseline and 8weeks, for all outcomes; and 16 weeks, for follow-up reasons for all outcomes.
The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms by Michigan Neuropathy Screening Instrument, (2) fuzzy score of the neuropathy severity, (3) tactile and vibration sensititivity (10-g monofilament and tuning fork), (4) foot-ankle kinematics and ankle kinetics during gait (infrared cameras and inverse dynamics, respectively), (5) foot isometric strength (by a pressure plate measurement), (6) functional balance reach test, (7) foot health and functionality by the Foot Health Status Questionnaire, (8) plantar pressure distribution during gait.
The hypothesis of this study is that the intervention will increase the perception of the tactile and vibratory sensitivity of the foot, reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, increase the functional balance score, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, promote a more physiological foot rollover with a redistribution of plantar pressure during gait, as well as increase foot-ankle mobility after 08-weeks of intervention. There will be also beneficial biomechanical changes during gait, such as: (1) increase in the ankle extensor moment and ankle concentric power in the propulsion phase and (3) increase in the ankle flexor moment and ankle eccentric power in the load phase.
- Conditions
- Diabetic Neuropathies
- Being tested
- Educational and home-based physical therapy by foot-related exercises
- Keywords
- exercise therapy, diabetic foot, preventive care, foot-related exercise, self-management, musculoskeletal function, Booklet, Primary Health Care
- Medical subject headings
- Diabetic Neuropathies, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational and home-based physical therapy by foot-related exercisesOther
The booklet is divided in 2: educational and exercise protocol. The aim of the first part is to guide the individual for a change in his/her health behavior, and comprises info about diabetic neuropathy, foot care, shoes, and benefits of exercising. The second part is the foot protocol, composed by 6 exercises. The maximum duration of a session is 20min and should be performed 3 times/week. The subject should warm-up the foot-ankle and then start exercising in the order suggested by the booklet, filling a table with the effort perceived (effort likert scale). The foot exercises progresses from one set with 30 repetitions in a sitting position, to exercising standing, then performing the exercise on one foot only. Other progression criterion is to increase the number of sets performed. The effort scale regulates the individual effort for his/her progression, which is also registered by the participant in the monthly table at the booklet.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients in the intervention group will perform foot-related exercises described in an educational booklet three times/week at home. In the follow-up period, patients will follow the same schedule set by the project till the end of the study (16-weeks). Receives: Other: Educational and home-based physical therapy by foot-related exercises |
| Control Group | No intervention | Participants in the control group will not receive any specific intervention in addition to the treatment recommended by the health professionals team (doctors, nurses, podiatrists), which includes pharmacological treatment, and self-care recommendations and foot care by international consensus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Diabetic Neuropathy Symptoms at 8-weeks
Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the neuropathy).
Measured: 8-weeks
Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 8-weeks
The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture (LaBIMPH) available free of charge at: http://www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.
Measured: 8-weeks
Change From Baseline Diabetic Neuropathy Symptoms at 16-weeks (Follow-up)
Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the neuropathy).
Measured: 16-weeks (Follow-up)
Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 16-weeks (Follow-up)
The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture (LaBIMPH) available free of charge at: http://www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.
Measured: 16-weeks (Follow-up)
Secondary outcomes (16)
Change From Baseline of the Foot and Ankle Kinematics During Gait at 8-weeks
Sagital plane of ankle range of motion - initial of dorsiflexion until the end of plantaflexion (degrees) during stance phase of gait.
Measured: 8-weeks
Change From Baseline of the Foot and Ankle Kinetics During Gait at 8-weeks
Peak joint moment of ankle plantarflexor moment at push off during stance phase of gait by inverse dynamic calculations
Measured: 8-weeks
Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 8-weeks
A pressure platform (emed®-q100, GmbH, Novel Munich, Germany) will be used to evaluate the pressure pattern during walking. The analysis of plantar pressure will be through the parameters: Heel peak pressure (kPa)
Measured: 8-weeks
Change From Baseline Tactile Sensitivity at 8-weeks
Tactile sensorial deficits will be evaluated by monofilament with a tactile stimulus of a 10-g monofilament in 4 plantar areas (plantar face of the hallux, heads of 1st, 3rd and 5th metatarsals). The areas will be evaluated in random order and not allowing the participant to view the monofilament. The number of areas where the participant does not feel the pressure will be indicated. The greater the number of areas marked without sensing, the greater the impairment of tactile sensitivity.
Measured: 8-weeks
Change From Baseline Vibration Sensitivity at 8-weeks
The vibration sensitivity will be assessed by vibrating a tuning fork (128Hz) in the dorsal region of the distal hallux phalanx. The participant should report the moment he/she does no longer feel the vibration of the tuning fork, and the evaluator must time the interval between which the participant reports that he/she ceases to feel the vibration and the moment the evaluator ceases to feel the vibration in the his/her hand. Values smaller than 10 seconds will be classified with present vibratory sensitivity; values greater than 10 seconds will be classified as decreased vibratory sensitivity. If the participant does not perceive the vibration imposed by the tuning fork, it will be classified as absent vibratory sensitivity.
Measured: 8-weeks
Change From Baseline Foot Health and Functionality at 8-weeks
The Brazilian version of the Foot-Health Status Questionnaire (FHSQ-BR) will be used. The domain assessed was function that receives a score from 0 to 100, where 100 expresses the best function and 0 to worst.
Measured: 8-weeks
Change From Baseline Foot Isometric Strength at 8-weeks
The muscle strength of the flexor muscles of the hallux and flexors of the toes will be evaluated using the emed®-q100 pressure platform (Novel, Germany) according to a test protocol already described elsewhere. The individual should stand, with the evaluated foot centered on the pressure platform, instructed to make as much force as possible with the hallux peak values of maximum force (% of bodyweight).
Measured: 8-weeks
Change From Baseline Functional Balance at 8-weeks
It is a clinical test where the patient will be standing barefoot, perpendicular to the wall, with the shoulder flexed 90° and the elbow extended. A tape measure will be attached to the wall, parallel to the floor, positioned at the height of the patient's acromion. The volunteer will be instructed to lean forward as much as possible without losing balance or taking a step. The displacement of the wrist will be measured by the tape. The greater the distance in centimeter, the better the functional balance
Measured: 8-weeks
Change From Baseline of the Foot and Ankle Kinematics During Gait at 16-weeks (Follow-up)
Sagital plane of ankle range of motion - initial of dorsiflexion until the end of plantaflexion (degrees) during stance phase of gait.
Measured: 16-weeks (Follow-up)
Change From Baseline of the Foot and Ankle Kinetics During Gait at 16-weeks (Follow-up)
Peak joint moment of ankle plantarflexor moment at push off during stance phase of gait by inverse dynamic calculations
Measured: 16-weeks (Follow-up)
Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 16-weeks (Follow-up)
A pressure platform (emed®-q100, GmbH, Novel Munich, Germany) will be used to evaluate the pressure pattern during walking. The analysis of plantar pressure will be through the parameters: Heel peak pressure (kPa)
Measured: 16-weeks (Follow-up)
Change From Baseline Tactile Sensitivity at 16-weeks (Follow-up)
Tactile sensorial deficits will be evaluated by monofilament with a tactile stimulus of a 10-g monofilament in 4 plantar areas (plantar face of the hallux, heads of 1st, 3rd and 5th metatarsals). The areas will be evaluated in random order and not allowing the participant to view the monofilament. The number of areas where the participant does not feel the pressure will be indicated. The greater the number of areas marked without sensing, the greater the impairment of tactile sensitivity.
Measured: 16-weeks (Follow-up)
Change From Baseline Vibration Sensitivity at 16-weeks (Follow-up)
The vibration sensitivity will be assessed by vibrating a tuning fork (128Hz) in the dorsal region of the distal hallux phalanx. The participant should report the moment he/she does no longer feel the vibration of the tuning fork, and the evaluator must time the interval between which the participant reports that he/she ceases to feel the vibration and the moment the evaluator ceases to feel the vibration in the his/her hand. Values smaller than 10 seconds will be classified with present vibratory sensitivity; values greater than 10 seconds will be classified as decreased vibratory sensitivity. If the participant does not perceive the vibration imposed by the tuning fork, it will be classified as absent vibratory sensitivity.
Measured: 16-weeks (follow-up)
Change From Baseline Foot Health and Functionality at 16-weeks (Follow-up)
The Brazilian version of the Foot-Health Status Questionnaire (FHSQ-BR) will be used. The domain assessed was function and it receives a score from 0 to 100, where 100 expresses the best function and 0 to worst.
Measured: 16-weeks (Follow-up)
Change From Baseline Foot Isometric Strength at 16-weeks (Follow-up)
The muscle strength of the flexor muscles of the hallux and flexors of the toes will be evaluated using the emed®-q100 pressure platform (Novel, Germany) according to a test protocol already described elsewhere. The individual should stand, with the evaluated foot centered on the pressure platform, instructed to make as much force as possible with the hallux peak values of maximum force (% of bodyweight).
Measured: 16-weeks (Follow-up)
Change From Baseline Functional Balance at 16-weeks (Follow-up)
It is a clinical test where the patient will be standing barefoot, perpendicular to the wall, with the shoulder flexed 90° and the elbow extended. A tape measure will be attached to the wall, parallel to the floor, positioned at the height of the patient's acromion. The volunteer will be instructed to lean forward as much as possible without losing balance or taking a step. The displacement of the wrist will be measured by the tape. The greater the distance in centimeter, the better the functional balance
Measured: 16-weeks (Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 May 2019
- Primary completion1 May 2021
- Study completion26 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Model description
- Assignment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Isabel de Camargo Neves Sacco, University of Sao Paulo General Hospital
- Investigators
- Isabel CN Sacco, PhD, Principal investigator, Associate Professor at São Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008745
- Sponsor's protocol ID
- FOCA-II
- Acronym
- FOCA-II
- Status last verified
- May 2024
- First submitted
- 2 Jul 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silva EQ, Santos DP, Beteli RI, Monteiro RL, Ferreira JSSP, Cruvinel-Junior RH, Donini A, Verissimo JL, Suda EY, Sacco ICN. Feasibility of a home-based foot-ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II. Sci Rep. 2021 Jun 11;11(1):12404. doi: 10.1038/s41598-021-91901-0.
PubMed 34117342Silva EQ, Suda EY, Santos DP, Verissimo JL, Ferreira JSSP, Cruvinel Junior RH, Monteiro RL, Sartor CD, Sacco ICN. Effect of an educational booklet for prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial II, a study protocol of a randomized controlled trial. Trials. 2020 Feb 13;21(1):180. doi: 10.1186/s13063-020-4115-8.
PubMed 32054510
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-II) Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04008745
- Acronym / sponsor ID
- FOCA-II / FOCA-II
- Conditions
- Diabetic Neuropathies
- Keywords
- exercise therapy, diabetic foot, preventive care, foot-related exercise, self-management, musculoskeletal function, Booklet, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 26 Nov 2021 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this trial is to investigate the effect of an educational booklet foot-related exercise in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy.
Detailed description
A randomized controlled trial will be performed with 48 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group that will perform exercises at home, three times a week, through the booklet for 8-weeks.
The subjects will be evaluated in 3 different times to access the effect of the intervention: baseline and 8weeks, for all outcomes; and 16 weeks, for follow-up reasons for all outcomes.
The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms by Michigan Neuropathy Screening Instrument, (2) fuzzy score of the neuropathy severity, (3) tactile and vibration sensititivity (10-g monofilament and tuning fork), (4) foot-ankle kinematics and ankle kinetics during gait (infrared cameras and inverse dynamics, respectively), (5) foot isometric strength (by a pressure plate measurement), (6) functional balance reach test, (7) foot health and functionality by the Foot Health Status Questionnaire, (8) plantar pressure distribution during gait.
The hypothesis of this study is that the intervention will increase the perception of the tactile and vibratory sensitivity of the foot, reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, increase the functional balance score, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, promote a more physiological foot rollover with a redistribution of plantar pressure during gait, as well as increase foot-ankle mobility after 08-weeks of intervention. There will be also beneficial biomechanical changes during gait, such as: (1) increase in the ankle extensor moment and ankle concentric power in the propulsion phase and (3) increase in the ankle flexor moment and ankle eccentric power in the load phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Educational and home-based physical therapy by foot-related exercisesPatients in the intervention group will perform foot-related exercises described in an educational booklet three times/week at home. In the follow-up period, patients will follow the same schedule set by the project till the end of the study (16-weeks). |
| Control Group | No intervention | –Participants in the control group will not receive any specific intervention in addition to the treatment recommended by the health professionals team (doctors, nurses, podiatrists), which includes pharmacological treatment, and self-care recommendations and foot care by international consensus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetes mellitus type 1 or 2;
- Moderate or severe neuropathy confirmed with the fuzzy software;
- Ability to walk independently in the laboratory
Key exclusion criteria (11 listed)
- Hallux amputation or total amputation of the foot;
- History of surgical procedure in the knee, ankle or hip;
- History of arthroplasty and / or lower limb orthosis or indication of lower limb arthroplasty throughout the intervention period;
- Neurological and / or rheumatologic diseases diagnosed;
- Inability to provide consistent information;
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 |
|---|---|---|
| Educational and home-based physical therapy by foot-related exercisesThe booklet is divided in 2: educational and exercise protocol. The aim of the first part is to guide the individual for a change in his/her health behavior, and comprises info about diabetic neuropathy, foot care, shoes, and benefits of exercising. The second part is the foot protocol, composed by 6 exercises. The maximum duration of a session is 20min and should be performed 3 times/week. The subject should warm-up the foot-ankle and then start exercising in the order suggested by the booklet, filling a table with the effort perceived (effort likert scale). The foot exercises progresses from one set with 30 repetitions in a sitting position, to exercising standing, then performing the exercise on one foot only. Other progression criterion is to increase the number of sets performed. The effort scale regulates the individual effort for his/her progression, which is also registered by the participant in the monthly table at the booklet. | Other | Intervention Group |
Primary outcome
Change From Baseline Diabetic Neuropathy Symptoms at 8-weeks
Time frame: 8-weeks
Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the neuropathy).
Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 8-weeks
Time frame: 8-weeks
The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture (LaBIMPH) available free of charge at: http://www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.
Change From Baseline Diabetic Neuropathy Symptoms at 16-weeks (Follow-up)
Time frame: 16-weeks (Follow-up)
Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the neuropathy).
Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 16-weeks (Follow-up)
Time frame: 16-weeks (Follow-up)
The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture (LaBIMPH) available free of charge at: http://www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.
16 secondary outcomes
Change From Baseline of the Foot and Ankle Kinematics During Gait at 8-weeks
Time frame: 8-weeks
Change From Baseline of the Foot and Ankle Kinetics During Gait at 8-weeks
Time frame: 8-weeks
Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 8-weeks
Time frame: 8-weeks
Change From Baseline Tactile Sensitivity at 8-weeks
Time frame: 8-weeks
Change From Baseline Vibration Sensitivity at 8-weeks
Time frame: 8-weeks
Change From Baseline Foot Health and Functionality at 8-weeks
Time frame: 8-weeks
Change From Baseline Foot Isometric Strength at 8-weeks
Time frame: 8-weeks
Change From Baseline Functional Balance at 8-weeks
Time frame: 8-weeks
Change From Baseline of the Foot and Ankle Kinematics During Gait at 16-weeks (Follow-up)
Time frame: 16-weeks (Follow-up)
Change From Baseline of the Foot and Ankle Kinetics During Gait at 16-weeks (Follow-up)
Time frame: 16-weeks (Follow-up)
Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 16-weeks (Follow-up)
Time frame: 16-weeks (Follow-up)
Change From Baseline Tactile Sensitivity at 16-weeks (Follow-up)
Time frame: 16-weeks (Follow-up)
Change From Baseline Vibration Sensitivity at 16-weeks (Follow-up)
Time frame: 16-weeks (follow-up)
Change From Baseline Foot Health and Functionality at 16-weeks (Follow-up)
Time frame: 16-weeks (Follow-up)
Change From Baseline Foot Isometric Strength at 16-weeks (Follow-up)
Time frame: 16-weeks (Follow-up)
Change From Baseline Functional Balance at 16-weeks (Follow-up)
Time frame: 16-weeks (Follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34117342Silva EQ, Santos DP, Beteli RI, Monteiro RL, Ferreira JSSP, Cruvinel-Junior RH, Donini A, Verissimo JL, Suda EY, Sacco ICN. Feasibility of a home-based foot-ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II. Sci Rep. 2021 Jun 11;11(1):12404. doi: 10.1038/s41598-021-91901-0.
- Derived from this study: PubMed 32054510Silva EQ, Suda EY, Santos DP, Verissimo JL, Ferreira JSSP, Cruvinel Junior RH, Monteiro RL, Sartor CD, Sacco ICN. Effect of an educational booklet for prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial II, a study protocol of a randomized controlled trial. Trials. 2020 Feb 13;21(1):180. doi: 10.1186/s13063-020-4115-8.
- University of Sao Paulo websiteLink provided by the sponsor.
- Laboratory of Biomechanics of Human Movement and Posture websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Isabel CN Sacco, PhD principal investigator
Associate Professor at São Paulo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational and home-based physical therapy by foot-related exercises in people with Diabetic Neuropathies, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Diabetic Neuropathy Symptoms at 8-weeks (time frame: 8-weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04008745, which also lists 2 linked publications.
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 19 Sep 2024.