Effects of Foot Muscle Strengthening in Daily Activity in Diabetic Neuropathic Patients

Effects of Foot Muscle Strengthening in Daily Activity, Biomechanics and Functionality of Foot and Ankle in Diabetic Polyneuropathy Patients: a Randomized Controlled Trial

The main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.

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.

Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months.

Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment.

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.

Foot joints and plantar arch motion, ankle range of motion, and maximum ankle extension and flexion during gait

Score of the Michigan Neuropathy Screening Instrument questionnaire Michigan Neuropathy Screening Instrument (MNSI)

Manual goniometry of the range of motion of flexion and extension of the metatarsophalangeal joint of the hallux and ankle.

Inclusion Criteria: Diabetes mellitus type 1 or 2 Moderate or severe polyneuropathy confirmed with the fuzzy software 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: Ulceration not healed for at least 6 months Hallux amputation or total amputation of the foot Receiving any physiotherapy intervention or offloading devices Neurological or orthopedic impairments Major vascular complications Severe retinopathy

Monteiro RL, Ferreira JSSP, Silva EQ, Cruvinel-Junior RH, Verissimo JL, Bus SA, Sacco ICN. Foot-ankle therapeutic exercise program can improve gait speed in people with diabetic neuropathy: a randomized controlled trial. Sci Rep. 2022 May 9;12(1):7561. doi: 10.1038/s41598-022-11745-0. Erratum In: Sci Rep. 2022 Jul 11;12(1):11768.

Monteiro RL, Sartor CD, Ferreira JSSP, Dantas MGB, Bus SA, Sacco ICN. Protocol for evaluating the effects of a foot-ankle therapeutic exercise program on daily activity, foot-ankle functionality, and biomechanics in people with diabetic polyneuropathy: a randomized controlled trial. BMC Musculoskelet Disord. 2018 Nov 14;19(1):400. doi: 10.1186/s12891-018-2323-0.