Diabetic Neuropathies
Conditions
Keywords
diabetic foot, therapeutic exercises, foot, preventive care, rehabilitation, Diabetic Neuropathy
Brief summary
The main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.
Detailed description
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.
Interventions
OTHERIntervention 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.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diabetes mellitus type 1 or 2 * Moderate or severe polyneuropathy confirmed with the fuzzy software * Ability to walk independently in the laboratory * Accessibility to electronic devices * Loss of at least 4 degrees of ankle range of motion * Loss of at least 1 degree of force in the clinical scale of the plantar interosseous or lumbrical muscles
Exclusion criteria
* Ulceration not healed for at least 6 months * Hallux amputation or total amputation of the foot * Receiving any physiotherapy intervention or offloading devices * Neurological or orthopedic impairments * Major vascular complications * Severe retinopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self Selected Gait Speed | 12 weeks | self selected gait speed shod walking velocity in a walkway |
| Fast Gait Speed | 12 weeks | Fast gait speed shod walking velocity in a walkway |
| Daily Physical Activity | 12 weeks | Calculate the number of steps per week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathy Symptoms | 12 weeks | Score of the Michigan Neuropathy Screening Instrument questionnaire Michigan Neuropathy Screening Instrument (MNSI) |
| Foot Health and Functionality | 12 weeks | Score of the Foot Health Status questionnaire - BRAZIL |
| Foot Strength | 12 weeks | Hallux and lesser toes force measured by a pressure plate |
| Foot and Ankle Kinematics During Gait | baseline, 12 weeks | Foot joints and plantar arch motion, ankle range of motion, and maximum ankle extension and flexion during gait |
| Ankle and Knee Joint Moments and Power During Gait | baseline, 12 weeks | Peak joint moment and eccentric and concentric power by inverse dynamic calculations |
| Plantar Ulcers | 12 months | New cases of foot plantar ulcers |
| Tactile Sensitivity | 12 weeks | Evaluation of the tactile sensitivity of four plantar areas with 10g monofilament |
| EQ-5D Score | 12 weeks | EQ-5D score of the quality of life of the patient |
| Vibration Sensitivity | 12 weeks | Evaluation of the vibration sensitivity with tuning fork |
| Range of Motion | 12 weeks | Manual goniometry of the range of motion of flexion and extension of the metatarsophalangeal joint of the hallux and ankle. |
| Risk Classification of Plantar Ulceration | 12 weeks | Score of the classification of the plantar ulcer risk (IWG diabetic foot) |
Countries
Brazil
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 39 |
| Control Group Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment. | 39 |
| Total | 78 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 11.7 | 60.1 years STANDARD_DEVIATION 8.9 | 60.8 years STANDARD_DEVIATION 10.3 |
| Body mass | 77.3 kg STANDARD_DEVIATION 14 | 80.8 kg STANDARD_DEVIATION 16.4 | 79 kg STANDARD_DEVIATION 15.2 |
| Daily physical activity | 8.092 Total Steps per week STANDARD_DEVIATION 4.23 | 7.641 Total Steps per week STANDARD_DEVIATION 4.087 | 7.866 Total Steps per week STANDARD_DEVIATION 4158 |
| Fast gait speed | 1.5 m/s STANDARD_DEVIATION 0.2 | 1.5 m/s STANDARD_DEVIATION 0.3 | 1.5 m/s STANDARD_DEVIATION 0.25 |
| Height | 1.6 m STANDARD_DEVIATION 0.08 | 1.6 m STANDARD_DEVIATION 0.09 | 1.6 m STANDARD_DEVIATION 0.08 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Brazil | 39 participants | 39 participants | 78 participants |
| Self-selected gait speed | 1.1 m/s STANDARD_DEVIATION 0.2 | 1.0 m/s STANDARD_DEVIATION 0.1 | 1.0 m/s STANDARD_DEVIATION 0.15 |
| Sex: Female, Male Female | 22 Participants | 21 Participants | 43 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 39 |
| other Total, other adverse events | 0 / 39 | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 |
Outcome results
Primary
Daily Physical Activity
Calculate the number of steps per week
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Daily Physical Activity | 8744 number of steps per week | Standard Deviation 810 |
| Control Group | Daily Physical Activity | 7373 number of steps per week | Standard Deviation 1010 |
Primary
Fast Gait Speed
Fast gait speed shod walking velocity in a walkway
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Fast Gait Speed | 1.68 m/s | Standard Deviation 0.06 |
| Control Group | Fast Gait Speed | 1.49 m/s | Standard Deviation 0.06 |
Primary
Self Selected Gait Speed
self selected gait speed shod walking velocity in a walkway
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Self Selected Gait Speed | 1.06 m/s | Standard Deviation 0.04 |
| Control Group | Self Selected Gait Speed | 1.00 m/s | Standard Deviation 0.04 |
Secondary
Ankle and Knee Joint Moments and Power During Gait
Peak joint moment and eccentric and concentric power by inverse dynamic calculations
Time frame: baseline, 12 weeks
Secondary
EQ-5D Score
EQ-5D score of the quality of life of the patient
Time frame: 12 weeks
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
Time frame: baseline, 12 weeks
Secondary
Foot Health and Functionality
Score of the Foot Health Status questionnaire - BRAZIL
Time frame: 12 weeks
Secondary
Foot Strength
Hallux and lesser toes force measured by a pressure plate
Time frame: 12 weeks
Secondary
Neuropathy Symptoms
Score of the Michigan Neuropathy Screening Instrument questionnaire Michigan Neuropathy Screening Instrument (MNSI)
Time frame: 12 weeks
Secondary
Plantar Ulcers
New cases of foot plantar ulcers
Time frame: 12 months
Secondary
Range of Motion
Manual goniometry of the range of motion of flexion and extension of the metatarsophalangeal joint of the hallux and ankle.
Time frame: 12 weeks
Secondary
Risk Classification of Plantar Ulceration
Score of the classification of the plantar ulcer risk (IWG diabetic foot)
Time frame: 12 weeks
Secondary
Tactile Sensitivity
Evaluation of the tactile sensitivity of four plantar areas with 10g monofilament
Time frame: 12 weeks
Secondary
Vibration Sensitivity
Evaluation of the vibration sensitivity with tuning fork
Time frame: 12 weeks