| Primary | 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). | | Posted | | Mean | Standard Deviation | units on a scale | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0005.3± 0.5
- OG0016.2± 0.6
|
|
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| Primary | 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. | | Posted | | Mean | Standard Deviation | score of a scale (0 to 10) | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
|
| Primary | 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). | | Posted | | Mean | Standard Deviation | score of a scale (0 to 13) | | 16-weeks (Follow-up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
| |
| Primary | 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. | | Posted | | Mean | Standard Deviation | score of a scale (0 to 10) | | 16-weeks (Follow-up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | degrees | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
| |
| Secondary | 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 | | Posted | | Mean | Standard Deviation | N*m/kg | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
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| Secondary | 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) | | Posted | | Mean | Standard Deviation | kPa | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
| |
| Secondary | 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. | | Posted | | Median | Inter-Quartile Range | Number of insentitive foot areas | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
| |
| Secondary | 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. | | Posted | | Count of Participants | | Participants | No | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
|
| Secondary | 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. | | Posted | | Mean | Standard Deviation | score on a scale (0 to 100) | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
| |
| Secondary | 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). | | Posted | | Mean | Standard Deviation | % bodyweight | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
| |
| Secondary | 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 | | Posted | | Mean | Standard Deviation | cm | | 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
| |
| Secondary | 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. | | Posted | | Mean | Standard Deviation | degrees | | 16-weeks (Follow-up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
| |
| Secondary | 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 | | Posted | | Mean | Standard Deviation | N*m/kg | | 16-weeks (Follow-up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
| |
| Secondary | 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) | | Posted | | Mean | Standard Deviation | kPa | | 16-weeks (Follow-up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
| |
| Secondary | 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. | | Posted | | Median | Inter-Quartile Range | Number of insentitive foot areas | | 16-weeks (Follow-up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
| |
| Secondary | 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. | | Posted | | Count of Participants | | Participants | No | 16-weeks (follow-up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
|
| Secondary | 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. | | Posted | | Mean | Standard Deviation | score on a scale (0 to 100) | | 16-weeks (Follow-up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
| |
| Secondary | 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). | | Posted | | Mean | Standard Deviation | % bodyweight | | 16-weeks (Follow-up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
| |
| Secondary | 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 | | Posted | | Mean | Standard Deviation | cm | | 16-weeks (Follow-up) | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group | 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). | | OG001 | Control Group | 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. |
| |