Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment in People With Diabetic Neuropathy (FOCA-I)

University of Sao Paulo General Hospital

Status: Completed

Conditions: Diabetic Neuropathies

Treatments: Other: Physical therapy by foot-ankle segmental and functional exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT04011267

FOCA-I

Details and patient eligibility

About

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 with diabetic neuropathy.

Full 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 international consensus with no foot exercises) or an intervention group that will perform exercises at home, three times a week, through the SOPeD (Diabetic Foot Guidance System) software for 12-weeks. The exercise program is customized during the performance by a perceived effort scale reported by the participant.

The subjects will be evaluated in 3 different times to access the effect of the intervention: baseline and 12 weeks, for all outcomes; and 24 weeks, for follow-up reasons for all outcomes. The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms and signs by Michigan Neuropathy Screening Instrument, (2) fuzzy score of the neuropathy severity, (3) foot-ankle kinematics during gait (infrared cameras) (4) foot-ankle joint moment during gait (infrared cameras and force plate), (5) plantar pressure distribution during gait, (6) tactile (monofilaments), (7) vibration sensitivity (tuning fork), (8) foot health and functionality by the Foot Health Status Questionnaire, (9) Foot isometric strength (pressure plate measurement), (10) functional balance reach test.

The hypothesis of this study is that the intervention will increase the perception of the tactile and vibratory sensitivity of the foot, reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, increase the functional balance score, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, promote a more physiological foot rollover with a redistribution of plantar pressure during gait, as well as increase foot-ankle mobility after 12-weeks of intervention. There will be also beneficial biomechanical changes during gait, such as: (1) increase in the ankle extensor moment and ankle concentric power in the propulsion phase and (3) increase in the ankle flexor moment and ankle eccentric power in the load phase.

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Patients in the intervention group will perform foot-related exercises described in the SOPeD software three times/week at home via web-software. In the follow-up period, patients will follow the same schedule set by the project till the end of the study.

Treatment:

Other: Physical therapy by foot-ankle segmental and functional exercises

Control Group

No Intervention group

Description:

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.