Status:
COMPLETED
Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment in People With Diabetic Neuropathy
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Diabetic Neuropathies
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The main objective of this trial is to investigate the effect of a customized foot-related exercises software (SOPeD) in diabetic neuropathy status, functional outcomes and gait biomechanics in people...
Detailed Description
A randomized controlled trial will be performed with 62 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by internationa...
Eligibility Criteria
Inclusion
- Diabetes mellitus type 1 or 2;
- Moderate or severe neuropathy confirmed with the fuzzy software;
- Ability to walk independently in the laboratory ;
- Accessibility to electronic devices (computers, mobile devices, tablets, etc.) access to exercise software.
Exclusion
- 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).
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04011267
Start Date
August 1 2019
End Date
September 1 2022
Last Update
March 3 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Universidade de São Paulo
São Paulo, Brazil, 05360-160