Health TrialsbyHealthPanel

FOot CAre and Exercises ImplementatioN for People With Diabetes in Primary Care

ConditionDiabetes; Neuropathy, Polyneuropathy (Manifestation)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital

About this trial

The main objective of this type 2 hybrid implementation effectiveness trial is to implement a contextually appropriate preventive intervention for 12 weeks face to face group foot and ankle exercises for people with diabetic foot in the primary care of the city of Limeira/SP, through the training of Primary Care workers. The study will monitor the implementation itself and the clinical outcomes: clinical and functional status and quality of life.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults of both sexes;

Diabetes mellitus type 1 or 2;

Residence within the catchment area of the Family Health Units.

Availability to participate in the intervention at the established group time.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Foot-related exercises

    Other intervention

    Face to face foot-related exercises, supervised by physiotherapist and based in the specific software (Sistema de Orientação do Pé diabético, SOPED) and or booklet, in addition to self-care recommendations and foot care by international consensus. The maximum duration of a session is 40 min and should be be performed 1-2 times/week. The subject should warm-up the foot-ankle and then start exercising in the order suggested by the physiotherapist. The foot exercises progresses from one set with 30 repetitions in a sitting position, to exercising standing, then performing the exercise on one foot only. Other progression criterion is to increase the number of sets performed. The effort scale regulates the individual effort for his/her progression.

Treatment groups

356 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change From Baseline Diabetic Neuropathy Symptoms at 12-week Instrument

Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the neuropathy)

Time frame
12 weeks
2

Change From Baseline of the Foot and Ankle range of motion at 12-week

Ankle and first metatarsophalangeal joint will be measured by manual goniometers.

Time frame
12 weeks

Secondary outcomes

1

Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 12-week

The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture available free of charge at: http:// www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.

Time frame
12 weeks
2

Change from baseline of the toes and hallux strength at 12-week

Toes and hallux (summed) strength will be measured by a pressure plate with the subjects pressing down the plataform with toes standing.

Time frame
12 weeks
3

Change from baseline of the hallux strength at 12-week

Hallux strength will be measured by the paper grip test using a card where the examiner places it under the participant's hallux, asking the participant to hold it firmly with the hallux. The examiner pulls the card with increasing force while the participant resists

Time frame
12 weeks
4

Change From Baseline Time up and go at 12-week

Time spent for the subjects to rise from a standard arm chair, walk to a marker 3 m away, turn, walk back, and sit down again.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo General Hospital

Lead sponsor

Source ClinicalTrials.gov
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