Clinical trial NCT04008745: Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment in People With Diabetic Neuropathy
Official title: Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-II) Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Keywords: exercise therapy
diabetic foot
preventive care
foot-related exercise
self-management
musculoskeletal function
Booklet
Primary Health Care
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2019-07-05
Enrollment: 50
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 an educational booklet foot-related exercise in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy.

Detailed description: A randomized controlled trial will be performed with 48 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 booklet for 8-weeks.

The subjects will be evaluated in 3 different times to access the effect of the intervention: baseline and 8weeks, for all outcomes; and 16 weeks, for follow-up reasons for all outcomes.

The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms by Michigan Neuropathy Screening Instrument, (2) fuzzy score of the neuropathy severity, (3) tactile and vibration sensititivity (10-g monofilament and tuning fork), (4) foot-ankle kinematics and ankle kinetics during gait (infrared cameras and inverse dynamics, respectively), (5) foot isometric strength (by a pressure plate measurement), (6) functional balance reach test, (7) foot health and functionality by the Foot Health Status Questionnaire, (8) plantar pressure distribution during gait.

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 08-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

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 8-weeks
timeFrame: 8-weeks
measure: Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 8-weeks
timeFrame: 8-weeks
measure: Change From Baseline Diabetic Neuropathy Symptoms at 16-weeks (Follow-up)
timeFrame: 16-weeks (Follow-up)
measure: Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 16-weeks (Follow-up)
timeFrame: 16-weeks (Follow-up)
Secondary outcomes:
measure: Change From Baseline of the Foot and Ankle Kinematics During Gait at 8-weeks
timeFrame: 8-weeks
measure: Change From Baseline of the Foot and Ankle Kinetics During Gait at 8-weeks
timeFrame: 8-weeks
measure: Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 8-weeks
timeFrame: 8-weeks
measure: Change From Baseline Tactile Sensitivity at 8-weeks
timeFrame: 8-weeks
measure: Change From Baseline Vibration Sensitivity at 8-weeks
timeFrame: 8-weeks
measure: Change From Baseline Foot Health and Functionality at 8-weeks
timeFrame: 8-weeks
measure: Change From Baseline Foot Isometric Strength at 8-weeks
timeFrame: 8-weeks
measure: Change From Baseline Functional Balance at 8-weeks
timeFrame: 8-weeks
measure: Change From Baseline of the Foot and Ankle Kinematics During Gait at 16-weeks (Follow-up)
timeFrame: 16-weeks (Follow-up)
measure: Change From Baseline of the Foot and Ankle Kinetics During Gait at 16-weeks (Follow-up)
timeFrame: 16-weeks (Follow-up)
measure: Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 16-weeks (Follow-up)
timeFrame: 16-weeks (Follow-up)
measure: Change From Baseline Tactile Sensitivity at 16-weeks (Follow-up)
timeFrame: 16-weeks (Follow-up)
measure: Change From Baseline Vibration Sensitivity at 16-weeks (Follow-up)
timeFrame: 16-weeks (follow-up)
measure: Change From Baseline Foot Health and Functionality at 16-weeks (Follow-up)
timeFrame: 16-weeks (Follow-up)
measure: Change From Baseline Foot Isometric Strength at 16-weeks (Follow-up)
timeFrame: 16-weeks (Follow-up)
measure: Change From Baseline Functional Balance at 16-weeks (Follow-up)
timeFrame: 16-weeks (Follow-up)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Érica Queiroz da Silva
state: SP
Study officials:
affiliation: Associate Professor at São Paulo University
name: Isabel CN Sacco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silva EQ, Santos DP, Beteli RI, Monteiro RL, Ferreira JSSP, Cruvinel-Junior RH, Donini A, Verissimo JL, Suda EY, Sacco ICN. Feasibility of a home-based foot-ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II. Sci Rep. 2021 Jun 11;11(1):12404. doi: 10.1038/s41598-021-91901-0.
citation: Silva EQ, Suda EY, Santos DP, Verissimo JL, Ferreira JSSP, Cruvinel Junior RH, Monteiro RL, Sartor CD, Sacco ICN. Effect of an educational booklet for prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial II, a study protocol of a randomized controlled trial. Trials. 2020 Feb 13;21(1):180. doi: 10.1186/s13063-020-4115-8.