Diabetic Neuropathies
Conditions
Keywords
exercise therapy, diabetic foot, preventive care, foot-related exercise, self-management, musculoskeletal function, Booklet, Primary Health Care
Brief 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.
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.
Interventions
OTHEREducational and home-based physical therapy by foot-related exercises
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.
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigator (allocation, statistics, data processing) and assessor will be blid to the subjects allocation. To evaluate whether or not there was a failure in blinding of the outcome assessor, investigators and other assessors, they will be asked to guess which group the patients belonged to at the end of 8-weeks of treatment. Then the assessors will classify the certainty of their opinions according to a scale (1 = not sure, 5 = completely sure). To ensure that the assessor is not induced to correctly guess the participants' allocation, the patient will be instructed to not disclose any behavior details during the previous 8-weeks.
Intervention model description
Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diabetes mellitus type 1 or 2; * Moderate or severe neuropathy confirmed with the fuzzy software; * Ability to walk independently in the laboratory
Exclusion criteria
* 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; * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Diabetic Neuropathy Symptoms at 8-weeks | 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 | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Vibration Sensitivity at 8-weeks | 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. |
| Change From Baseline Foot Health and Functionality at 8-weeks | 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. |
| Change From Baseline Foot Isometric Strength at 8-weeks | 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). |
| Change From Baseline Functional Balance at 8-weeks | 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 |
| Change From Baseline of the Foot and Ankle Kinematics During Gait at 16-weeks (Follow-up) | 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. |
| Change From Baseline of the Foot and Ankle Kinetics During Gait at 16-weeks (Follow-up) | 16-weeks (Follow-up) | Peak joint moment of ankle plantarflexor moment at push off during stance phase of gait by inverse dynamic calculations |
| Change From Baseline of the Foot and Ankle Kinematics During Gait at 8-weeks | 8-weeks | Sagital plane of ankle range of motion - initial of dorsiflexion until the end of plantaflexion (degrees) during stance phase of gait. |
| Change From Baseline Tactile Sensitivity at 16-weeks (Follow-up) | 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. |
| Change From Baseline Vibration Sensitivity at 16-weeks (Follow-up) | 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. |
| Change From Baseline Foot Health and Functionality at 16-weeks (Follow-up) | 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. |
| Change From Baseline Foot Isometric Strength at 16-weeks (Follow-up) | 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). |
| Change From Baseline Functional Balance at 16-weeks (Follow-up) | 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 |
| Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 16-weeks (Follow-up) | 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) |
| Change From Baseline of the Foot and Ankle Kinetics During Gait at 8-weeks | 8-weeks | Peak joint moment of ankle plantarflexor moment at push off during stance phase of gait by inverse dynamic calculations |
| Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 8-weeks | 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) |
| Change From Baseline Tactile Sensitivity at 8-weeks | 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. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 25 |
| 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. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 59.1 years STANDARD_DEVIATION 6.4 | 56.5 years STANDARD_DEVIATION 9.4 | 57.8 years STANDARD_DEVIATION 7.9 |
| Body mass index (kg/m2) | 23.5 kg/m^2 STANDARD_DEVIATION 4.8 | 22.9 kg/m^2 STANDARD_DEVIATION 3.6 | 23.2 kg/m^2 STANDARD_DEVIATION 4.2 |
| DPN symptoms - Michigan Neuropathy Screening Instrument | 5.4 score on a scale STANDARD_DEVIATION 1.9 | 6.9 score on a scale STANDARD_DEVIATION 2.1 | 6.2 score on a scale STANDARD_DEVIATION 1.6 |
| Fuzzy classification of the DPN severity | 4.4 units on a scale STANDARD_DEVIATION 2.6 | 4.9 units on a scale STANDARD_DEVIATION 2.2 | 4.6 units on a scale STANDARD_DEVIATION 2.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Brazil | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 19 Participants | 20 Participants | 39 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
| Time of onset of diabetes | 13.8 years STANDARD_DEVIATION 10 | 18.2 years STANDARD_DEVIATION 9.8 | 16 years STANDARD_DEVIATION 9.9 |
| Type 2 Diabetes | 22 Participants | 19 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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).
Time frame: 16-weeks (Follow-up)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline Diabetic Neuropathy Symptoms at 16-weeks (Follow-up) | 5.6 score of a scale (0 to 13) | Standard Deviation 0.5 |
| Control Group | Change From Baseline Diabetic Neuropathy Symptoms at 16-weeks (Follow-up) | 6.0 score of a scale (0 to 13) | Standard Deviation 0.6 |
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).
Time frame: 8-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline Diabetic Neuropathy Symptoms at 8-weeks | 5.3 units on a scale | Standard Deviation 0.5 |
| Control Group | Change From Baseline Diabetic Neuropathy Symptoms at 8-weeks | 6.2 units on a scale | Standard Deviation 0.6 |
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.
Time frame: 16-weeks (Follow-up)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 16-weeks (Follow-up) | 3.9 score of a scale (0 to 10) | Standard Deviation 0.6 |
| Control Group | Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 16-weeks (Follow-up) | 3.6 score of a scale (0 to 10) | Standard Deviation 0.4 |
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.
Time frame: 8-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 8-weeks | 3.7 score of a scale (0 to 10) | Standard Deviation 0.5 |
| Control Group | Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 8-weeks | 3.3 score of a scale (0 to 10) | Standard Deviation 0.5 |
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)
Time frame: 16-weeks (Follow-up)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 16-weeks (Follow-up) | 339.9 kPa | Standard Deviation 15.7 |
| Control Group | Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 16-weeks (Follow-up) | 378.4 kPa | Standard Deviation 22.7 |
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)
Time frame: 8-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 8-weeks | 338.2 kPa | Standard Deviation 19 |
| Control Group | Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 8-weeks | 402.4 kPa | Standard Deviation 21.2 |
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.
Time frame: 16-weeks (Follow-up)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline Foot Health and Functionality at 16-weeks (Follow-up) | 40.3 score on a scale (0 to 100) | Standard Deviation 4.9 |
| Control Group | Change From Baseline Foot Health and Functionality at 16-weeks (Follow-up) | 42.6 score on a scale (0 to 100) | Standard Deviation 6.2 |
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.
Time frame: 8-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline Foot Health and Functionality at 8-weeks | 37.0 score on a scale (0 to 100) | Standard Deviation 6.1 |
| Control Group | Change From Baseline Foot Health and Functionality at 8-weeks | 36.3 score on a scale (0 to 100) | Standard Deviation 5.1 |
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).
Time frame: 16-weeks (Follow-up)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline Foot Isometric Strength at 16-weeks (Follow-up) | 13.1 % bodyweight | Standard Deviation 1.3 |
| Control Group | Change From Baseline Foot Isometric Strength at 16-weeks (Follow-up) | 12.0 % bodyweight | Standard Deviation 1.2 |
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).
Time frame: 8-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline Foot Isometric Strength at 8-weeks | 13.8 % bodyweight | Standard Deviation 1.1 |
| Control Group | Change From Baseline Foot Isometric Strength at 8-weeks | 11.6 % bodyweight | Standard Deviation 1.3 |
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
Time frame: 16-weeks (Follow-up)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline Functional Balance at 16-weeks (Follow-up) | 26.0 cm | Standard Deviation 1.1 |
| Control Group | Change From Baseline Functional Balance at 16-weeks (Follow-up) | 22.9 cm | Standard Deviation 1.1 |
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
Time frame: 8-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline Functional Balance at 8-weeks | 25.7 cm | Standard Deviation 1.3 |
| Control Group | Change From Baseline Functional Balance at 8-weeks | 25.5 cm | Standard Deviation 1.3 |
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.
Time frame: 16-weeks (Follow-up)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline of the Foot and Ankle Kinematics During Gait at 16-weeks (Follow-up) | 24.6 degrees | Standard Deviation 0.9 |
| Control Group | Change From Baseline of the Foot and Ankle Kinematics During Gait at 16-weeks (Follow-up) | 24.6 degrees | Standard Deviation 0.8 |
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.
Time frame: 8-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline of the Foot and Ankle Kinematics During Gait at 8-weeks | 23.7 degrees | Standard Deviation 0.8 |
| Control Group | Change From Baseline of the Foot and Ankle Kinematics During Gait at 8-weeks | 22.7 degrees | Standard Deviation 0.8 |
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
Time frame: 16-weeks (Follow-up)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline of the Foot and Ankle Kinetics During Gait at 16-weeks (Follow-up) | 1.20 N*m/kg | Standard Deviation 0.05 |
| Control Group | Change From Baseline of the Foot and Ankle Kinetics During Gait at 16-weeks (Follow-up) | 1.25 N*m/kg | Standard Deviation 0.03 |
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
Time frame: 8-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change From Baseline of the Foot and Ankle Kinetics During Gait at 8-weeks | 1.3 N*m/kg | Standard Deviation 0.1 |
| Control Group | Change From Baseline of the Foot and Ankle Kinetics During Gait at 8-weeks | 1.2 N*m/kg | Standard Deviation 0.1 |
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.
Time frame: 16-weeks (Follow-up)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Change From Baseline Tactile Sensitivity at 16-weeks (Follow-up) | 0 Number of insentitive foot areas |
| Control Group | Change From Baseline Tactile Sensitivity at 16-weeks (Follow-up) | 0 Number of insentitive foot areas |
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.
Time frame: 8-weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Change From Baseline Tactile Sensitivity at 8-weeks | 0 Number of insentitive foot areas |
| Control Group | Change From Baseline Tactile Sensitivity at 8-weeks | 0 Number of insentitive foot areas |
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.
Time frame: 16-weeks (follow-up)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group | Change From Baseline Vibration Sensitivity at 16-weeks (Follow-up) | absent - L R | 6 Participants |
| Intervention Group | Change From Baseline Vibration Sensitivity at 16-weeks (Follow-up) | reduced - L R | 15 Participants |
| Control Group | Change From Baseline Vibration Sensitivity at 16-weeks (Follow-up) | absent - L R | 2 Participants |
| Control Group | Change From Baseline Vibration Sensitivity at 16-weeks (Follow-up) | reduced - L R | 15 Participants |
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.
Time frame: 8-weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group | Change From Baseline Vibration Sensitivity at 8-weeks | absent - L R | 12 Participants |
| Intervention Group | Change From Baseline Vibration Sensitivity at 8-weeks | reduced - L R | 11 Participants |
| Control Group | Change From Baseline Vibration Sensitivity at 8-weeks | absent - L R | 11 Participants |
| Control Group | Change From Baseline Vibration Sensitivity at 8-weeks | reduced - L R | 9 Participants |