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The main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.
A randomized controlled trial will be performed with 77 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no exercises) or an intervention group which will receive 12-week physical therapy exercises, twice a week, under the supervision of a physiotherapist, and twice a week being remotely supervised by a software at home. Every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty.
The subjects will be evaluated in 5 different moments (Baseline, 6 weeks, 12 weeks, 24 weeks and 1 year follow-up)
The hypothesis of this study is that the intervention group will increase daily activity levels, increase self-selected and rapid walking speed, reduce the incidence of plantar ulcers, increase foot health and functionality, improve symptoms, increase tactile and vibration sensitivity, increased passive range of motion, improved quality of life, increased isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group after 12 weeks of intervention and follow-up year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months. |
|
| Control Group | No Intervention | Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Group | Other | Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months, for foot and ankle strengthening, stretching and functional training. They must continue to exercise at home twice a week with the software supervision for one year. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Physical Activity | Calculate the number of steps per week | 12 weeks |
| Self Selected Gait Speed | self selected gait speed shod walking velocity in a walkway | 12 weeks |
| Fast Gait Speed | Fast gait speed shod walking velocity in a walkway | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Risk Classification of Plantar Ulceration | Score of the classification of the plantar ulcer risk (IWG diabetic foot) | 12 weeks |
| Foot Health and Functionality | Score of the Foot Health Status questionnaire - BRAZIL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabel CN Sacco, PhD | Associate Professor at São Paulo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade de São Paulo | São Paulo | 05360-160 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35534614 | Derived | Monteiro RL, Ferreira JSSP, Silva EQ, Cruvinel-Junior RH, Verissimo JL, Bus SA, Sacco ICN. Foot-ankle therapeutic exercise program can improve gait speed in people with diabetic neuropathy: a randomized controlled trial. Sci Rep. 2022 May 9;12(1):7561. doi: 10.1038/s41598-022-11745-0. | |
| 30428863 | Derived | Monteiro RL, Sartor CD, Ferreira JSSP, Dantas MGB, Bus SA, Sacco ICN. Protocol for evaluating the effects of a foot-ankle therapeutic exercise program on daily activity, foot-ankle functionality, and biomechanics in people with diabetic polyneuropathy: a randomized controlled trial. BMC Musculoskelet Disord. 2018 Nov 14;19(1):400. doi: 10.1186/s12891-018-2323-0. |
| Label | URL |
|---|---|
| Laboratory of Biomechanics of Human Movement and Posture website | View source |
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It was enrolled 78 participants (1 more than the protocol) because the main research intended to keep the number of participants in each group equal.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months. Intervention Group: Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months, for foot and ankle strengthening, stretching and functional training. They must continue to exercise at home twice a week with the software supervision for one year. |
| FG001 | Control Group | Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months. Intervention Group: Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months, for foot and ankle strengthening, stretching and functional training. They must continue to exercise at home twice a week with the software supervision for one year. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Daily Physical Activity | Calculate the number of steps per week | Posted | Mean | Standard Deviation | number of steps per week | 12 weeks |
|
During the intervention period (aproximately 12 weeks)
There was no serious adverse and all-cause mortality in the control and in the intervention groups.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months. Intervention Group: Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months, for foot and ankle strengthening, stretching and functional training. They must continue to exercise at home twice a week with the software supervision for one year. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Isabel de Camargo Neves Sacco | University of Sao Paulo | +551130918426 | icnsacco@usp.br |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2018 | Sep 26, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 21, 2018 | Sep 26, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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|
|
| 12 weeks |
| Foot Strength | Hallux and lesser toes force measured by a pressure plate | 12 weeks |
| Foot and Ankle Kinematics During Gait | Foot joints and plantar arch motion, ankle range of motion, and maximum ankle extension and flexion during gait | baseline, 12 weeks |
| Ankle and Knee Joint Moments and Power During Gait | Peak joint moment and eccentric and concentric power by inverse dynamic calculations | baseline, 12 weeks |
| Plantar Ulcers | New cases of foot plantar ulcers | 12 months |
| Tactile Sensitivity | Evaluation of the tactile sensitivity of four plantar areas with 10g monofilament | 12 weeks |
| Vibration Sensitivity | Evaluation of the vibration sensitivity with tuning fork | 12 weeks |
| Neuropathy Symptoms | Score of the Michigan Neuropathy Screening Instrument questionnaire Michigan Neuropathy Screening Instrument (MNSI) | 12 weeks |
| Range of Motion | Manual goniometry of the range of motion of flexion and extension of the metatarsophalangeal joint of the hallux and ankle. | 12 weeks |
| EQ-5D Score | EQ-5D score of the quality of life of the patient | 12 weeks |
| University of Sao Paulo website | View source |
| BG001 | Control Group | Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Daily physical activity | Mean | Standard Deviation | Total Steps per week |
|
| Fast gait speed | Mean | Standard Deviation | m/s |
|
| Self-selected gait speed | Mean | Standard Deviation | m/s |
|
| Height | Mean | Standard Deviation | m |
|
| Body mass | Mean | Standard Deviation | kg |
|
|
|
| Primary | Self Selected Gait Speed | self selected gait speed shod walking velocity in a walkway | Posted | Mean | Standard Deviation | m/s | 12 weeks |
|
|
|
| Primary | Fast Gait Speed | Fast gait speed shod walking velocity in a walkway | Posted | Mean | Standard Deviation | m/s | 12 weeks |
|
|
|
| Secondary | Risk Classification of Plantar Ulceration | Score of the classification of the plantar ulcer risk (IWG diabetic foot) | Not Posted | 12 weeks | Participants |
| Secondary | Foot Health and Functionality | Score of the Foot Health Status questionnaire - BRAZIL | Not Posted | 12 weeks | Participants |
| Secondary | Foot Strength | Hallux and lesser toes force measured by a pressure plate | Not Posted | 12 weeks | Participants |
| Secondary | Foot and Ankle Kinematics During Gait | Foot joints and plantar arch motion, ankle range of motion, and maximum ankle extension and flexion during gait | Not Posted | baseline, 12 weeks | Participants |
| Secondary | Ankle and Knee Joint Moments and Power During Gait | Peak joint moment and eccentric and concentric power by inverse dynamic calculations | Not Posted | baseline, 12 weeks | Participants |
| Secondary | Plantar Ulcers | New cases of foot plantar ulcers | Not Posted | 12 months | Participants |
| Secondary | Tactile Sensitivity | Evaluation of the tactile sensitivity of four plantar areas with 10g monofilament | Not Posted | 12 weeks | Participants |
| Secondary | Vibration Sensitivity | Evaluation of the vibration sensitivity with tuning fork | Not Posted | 12 weeks | Participants |
| Secondary | Neuropathy Symptoms | Score of the Michigan Neuropathy Screening Instrument questionnaire Michigan Neuropathy Screening Instrument (MNSI) | Not Posted | 12 weeks | Participants |
| Secondary | Range of Motion | Manual goniometry of the range of motion of flexion and extension of the metatarsophalangeal joint of the hallux and ankle. | Not Posted | 12 weeks | Participants |
| Secondary | EQ-5D Score | EQ-5D score of the quality of life of the patient | Not Posted | 12 weeks | Participants |
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Control Group | Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment. | 0 | 39 | 0 | 39 | 0 | 39 |
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| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |