Effects of Foot Muscle Strengthening in Daily Activity in Diabetic Neuropathic Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Group Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months. |
Other: 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.
Other Names:
|
| No Intervention: Control Group Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment. |
Outcome Measures
Primary Outcome Measures
- daily physical activity [baseline, 12 weeks and 12 months]
Calculate the number of steps during 1 week
- Self selected gait speed [baseline,12 weeks and 12 months]
self selected gait speed shod walking velocity in a walkway
- Fast gait speed [baseline,12 weeks and 12 months]
Fast gait speed shod walking velocity in a walkway
Secondary Outcome Measures
- Risk classification of plantar ulceration [baseline,6, 12, 24 weeks and 12 months]
Score of the classification of the plantar ulcer risk (IWG diabetic foot)
- Foot health and functionality [baseline, 6, 12, 24 weeks and 12 months]
Score of the Foot Health Status questionnaire - BRAZIL
- Foot strength [baseline, 6, 12, 24 weeks and 12 months]
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
- Incidence of plantar ulcers [baseline, During 12 months]
New cases of plantar ulcers
- Tactile sensitivity [baseline, 6, 12, 24 weeks and 12 months]
Evaluation of the tactile sensitivity of four plantar areas with 10g monofilament
- Vibration sensitivity [baseline, 6, 12, 24 weeks and 12 months]
Evaluation of the vibration sensitivity with tuning fork
- Symptoms [baseline, 6, 12, 24 weeks and 12 months]
Score of the Michigan Neuropathy Screening Instrument questionnaire Michigan Neuropathy Screening Instrument (MNSI)
- Range of motion [baseline, 6, 12, 24 weeks and 12 months]
Manual goniometry of the range of motion of flexion and extension of the metatarsophalangeal joint of the hallux and ankle.
- EQ-5D score of the quality of life [baseline, 6, 12, 24 weeks and 12 months]
EQ-5D score of the quality of life
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diabetes mellitus type 1 or 2
-
Moderate or severe polyneuropathy confirmed with the fuzzy software
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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:
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Ulceration not healed for at least 6 months
-
Hallux amputation or total amputation of the foot
-
Receiving any physiotherapy intervention or offloading devices
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Neurological or orthopedic impairments
-
Major vascular complications
-
Severe retinopathy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universidade de São Paulo | São Paulo | Brazil | 05360-160 |
Sponsors and Collaborators
- University of Sao Paulo General Hospital
Investigators
- Principal Investigator: Isabel CN Sacco, PhD, Associate Professor at São Paulo University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- LaBiMPH