Trial Outcomes & Findings for Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment in People With Diabetic Neuropathy (NCT NCT04008745)
NCT ID: NCT04008745
Last Updated: 2024-09-19
Results Overview
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).
COMPLETED
NA
50 participants
8-weeks
2024-09-19
Participant Flow
Participant milestones
| Measure |
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).
Educational 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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 6.4 • n=25 Participants
|
56.5 years
STANDARD_DEVIATION 9.4 • n=25 Participants
|
57.8 years
STANDARD_DEVIATION 7.9 • n=50 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=25 Participants
|
20 Participants
n=25 Participants
|
39 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
11 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Brazil
|
25 participants
n=25 Participants
|
25 participants
n=25 Participants
|
50 participants
n=50 Participants
|
|
Type 2 Diabetes
|
22 Participants
n=25 Participants
|
19 Participants
n=25 Participants
|
41 Participants
n=50 Participants
|
|
Time of onset of diabetes
|
13.8 years
STANDARD_DEVIATION 10 • n=25 Participants
|
18.2 years
STANDARD_DEVIATION 9.8 • n=25 Participants
|
16 years
STANDARD_DEVIATION 9.9 • n=50 Participants
|
|
DPN symptoms - Michigan Neuropathy Screening Instrument
|
5.4 score on a scale
STANDARD_DEVIATION 1.9 • n=25 Participants
|
6.9 score on a scale
STANDARD_DEVIATION 2.1 • n=25 Participants
|
6.2 score on a scale
STANDARD_DEVIATION 1.6 • n=50 Participants
|
|
Fuzzy classification of the DPN severity
|
4.4 units on a scale
STANDARD_DEVIATION 2.6 • n=25 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 2.2 • n=25 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 2.4 • n=50 Participants
|
|
Body mass index (kg/m2)
|
23.5 kg/m^2
STANDARD_DEVIATION 4.8 • n=25 Participants
|
22.9 kg/m^2
STANDARD_DEVIATION 3.6 • n=25 Participants
|
23.2 kg/m^2
STANDARD_DEVIATION 4.2 • n=50 Participants
|
PRIMARY outcome
Timeframe: 8-weeksScore 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).
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline Diabetic Neuropathy Symptoms at 8-weeks
|
5.3 units on a scale
Standard Deviation 0.5
|
6.2 units on a scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: 8-weeksThe 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.
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
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
|
3.3 score of a scale (0 to 10)
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline Diabetic Neuropathy Symptoms at 16-weeks (Follow-up)
|
5.6 score of a scale (0 to 13)
Standard Deviation 0.5
|
6.0 score of a scale (0 to 13)
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
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
|
3.6 score of a scale (0 to 10)
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 8-weeksSagital plane of ankle range of motion - initial of dorsiflexion until the end of plantaflexion (degrees) during stance phase of gait.
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline of the Foot and Ankle Kinematics During Gait at 8-weeks
|
23.7 degrees
Standard Deviation 0.8
|
22.7 degrees
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 8-weeksPeak joint moment of ankle plantarflexor moment at push off during stance phase of gait by inverse dynamic calculations
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline of the Foot and Ankle Kinetics During Gait at 8-weeks
|
1.3 N*m/kg
Standard Deviation 0.1
|
1.2 N*m/kg
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 8-weeksA 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)
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 8-weeks
|
338.2 kPa
Standard Deviation 19.0
|
402.4 kPa
Standard Deviation 21.2
|
SECONDARY outcome
Timeframe: 8-weeksTactile 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.
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=24 Participants
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.
|
|---|---|---|
|
Change From Baseline Tactile Sensitivity at 8-weeks
|
0 Number of insentitive foot areas
Interval 0.0 to 1.0
|
0 Number of insentitive foot areas
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 8-weeksThe 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.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
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).
|
Control Group
n=20 Participants
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.
|
|---|---|---|
|
Change From Baseline Vibration Sensitivity at 8-weeks
absent - L R
|
12 Participants
|
11 Participants
|
|
Change From Baseline Vibration Sensitivity at 8-weeks
reduced - L R
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 8-weeksThe 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.
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline Foot Health and Functionality at 8-weeks
|
37.0 score on a scale (0 to 100)
Standard Deviation 6.1
|
36.3 score on a scale (0 to 100)
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 8-weeksThe 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).
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline Foot Isometric Strength at 8-weeks
|
13.8 % bodyweight
Standard Deviation 1.1
|
11.6 % bodyweight
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 8-weeksIt 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
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline Functional Balance at 8-weeks
|
25.7 cm
Standard Deviation 1.3
|
25.5 cm
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline of the Foot and Ankle Kinematics During Gait at 16-weeks (Follow-up)
|
24.6 degrees
Standard Deviation 0.9
|
24.6 degrees
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 16-weeks (Follow-up)Peak joint moment of ankle plantarflexor moment at push off during stance phase of gait by inverse dynamic calculations
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
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
|
1.25 N*m/kg
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 16-weeks (Follow-up)
|
339.9 kPa
Standard Deviation 15.7
|
378.4 kPa
Standard Deviation 22.7
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline Tactile Sensitivity at 16-weeks (Follow-up)
|
0 Number of insentitive foot areas
Interval 0.0 to 0.0
|
0 Number of insentitive foot areas
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention Group
n=21 Participants
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).
|
Control Group
n=17 Participants
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.
|
|---|---|---|
|
Change From Baseline Vibration Sensitivity at 16-weeks (Follow-up)
absent - L R
|
6 Participants
|
2 Participants
|
|
Change From Baseline Vibration Sensitivity at 16-weeks (Follow-up)
reduced - L R
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
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
|
42.6 score on a scale (0 to 100)
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline Foot Isometric Strength at 16-weeks (Follow-up)
|
13.1 % bodyweight
Standard Deviation 1.3
|
12.0 % bodyweight
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Intervention Group
n=25 Participants
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).
|
Control Group
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline Functional Balance at 16-weeks (Follow-up)
|
26.0 cm
Standard Deviation 1.1
|
22.9 cm
Standard Deviation 1.1
|
Adverse Events
Intervention Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place