Clinical trial NCT04011267: Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment in People With Diabetic Neuropathy
Official title: Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-I) Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Keywords: exercise therapy
diabetic foot
preventive care
foot-related exercises
self-management
software
musculoskeletal function
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2019-07-08
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment
Primary purpose: TREATMENT

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 with diabetic neuropathy.

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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from Baseline Diabetic neuropathy symptoms at 12-weeks
timeFrame: 12-weeks, 24-weeks (follow-up)
measure: Change from Baseline of the Fuzzy classification of the diabetic neuropathy severity at 12-weeks
timeFrame: 12-weeks, 24-weeks (follow-up)
Secondary outcomes:
measure: Change from Baseline of the foot and ankle kinematics during gait at 12-weeks
timeFrame: 12-weeks, 24-weeks (follow-up)
measure: Change from Baseline of the foot-ankle joint moment during gait at 12-weeks
timeFrame: 12-weeks, 24-weeks (follow-up)
measure: Change from Baseline Dynamic Plantar Pressure Distribution during gait at 12-weeks
timeFrame: 12-weeks, 24-weeks (follow-up)
measure: Change from Baseline Tactile sensitivity at 12-weeks
timeFrame: 12-weeks, 24-weeks (follow-up)
measure: Change from Baseline Vibration sensitivity at 12-weeks
timeFrame: 12-weeks, 24-weeks (follow-up)
measure: Change from Baseline Foot health and functionality at 12-weeks
timeFrame: 12-weeks, 24-weeks (follow-up)
measure: Change from Baseline Foot isometric strength at 12-weeks
timeFrame: 12-weeks, 24-weeks (follow-up)
measure: Change from Baseline Functional balance at 12-weeks
timeFrame: 12-weeks, 24-weeks (follow-up)
measure: Cost Effectiveness and cost utility
timeFrame: 12-weeks, 24-weeks (follow-up)
measure: Quality Adjusted Life Years
timeFrame: 12-weeks, 24-weeks (follow-up)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade de São Paulo
Study officials:
affiliation: Associate Professor at São Paulo University
name: Isabel de Camargo Neves Sacco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cruvinel Junior RH, Ferreira JSSP, Beteli RI, Silva EQ, Verissimo JL, Monteiro RL, Suda EY, Sacco ICN. Foot-ankle functional outcomes of using the Diabetic Foot Guidance System (SOPeD) for people with diabetic neuropathy: a feasibility study for the single-blind randomized controlled FOotCAre (FOCA) trial I. Pilot Feasibility Stud. 2021 Mar 26;7(1):87. doi: 10.1186/s40814-021-00826-y.
citation: Ferreira JSSP, Cruvinel Junior RH, Silva EQ, Verissimo JL, Monteiro RL, Pereira DS, Suda EY, Sartor CD, Sacco ICN. Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I. Trials. 2020 Jan 13;21(1):73. doi: 10.1186/s13063-019-4017-9.