Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment in People With Diabetic Neuropathy

NCT04008745 | Completed Results DMC

• 1 other identifier: FOCA-II
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathies

Keywords

exercise therapy; diabetic foot; preventive care; foot-related exercise; self-management; musculoskeletal function; Booklet; Primary Health Care

Outcome Measures

Primary Outcomes (4)

• Change From Baseline Diabetic Neuropathy Symptoms at 8-weeks

  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).

  8-weeks

• Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 8-weeks

  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 (LaBIMPH) 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.

  8-weeks

• Change From Baseline Diabetic Neuropathy Symptoms at 16-weeks (Follow-up)

  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).

  16-weeks (Follow-up)

• Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 16-weeks (Follow-up)

  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 (LaBIMPH) 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.

  16-weeks (Follow-up)

Secondary Outcomes (16)

• Change From Baseline of the Foot and Ankle Kinematics During Gait at 8-weeks

  8-weeks

• Change From Baseline of the Foot and Ankle Kinetics During Gait at 8-weeks

  8-weeks

• Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 8-weeks

  8-weeks

• Change From Baseline Tactile Sensitivity at 8-weeks

  8-weeks

• Change From Baseline Vibration Sensitivity at 8-weeks

  8-weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients in the intervention group will perform foot-related exercises described in an educational booklet three times/week at home. In the follow-up period, patients will follow the same schedule set by the project till the end of the study (16-weeks).

Other: Educational and home-based physical therapy by foot-related exercises

Control Group

NO INTERVENTION

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.

Interventions

Educational and home-based physical therapy by foot-related exercises OTHER

The booklet is divided in 2: educational and exercise protocol. The aim of the first part is to guide the individual for a change in his/her health behavior, and comprises info about diabetic neuropathy, foot care, shoes, and benefits of exercising. The second part is the foot protocol, composed by 6 exercises. The maximum duration of a session is 20min and should be performed 3 times/week. The subject should warm-up the foot-ankle and then start exercising in the order suggested by the booklet, filling a table with the effort perceived (effort likert scale). 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, which is also registered by the participant in the monthly table at the booklet.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus type 1 or 2;
• Moderate or severe neuropathy confirmed with the fuzzy software;
• Ability to walk independently in the laboratory

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Érica Queiroz da Silva

São Paulo, São Paulo, 05360160, Brazil

Location

Related Publications (2)

• 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.

  PMID: 34117342 DERIVED

• 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.

  PMID: 32054510 DERIVED

Related Links

• University of Sao Paulo website
• Laboratory of Biomechanics of Human Movement and Posture website

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetic Foot

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

It was a relatively short intervention period for major musculoskeletal and biomechanical changes, there was limited control over the exercise intensity, and only six exercises were included in the booklet. The participants were not blinded to the treatment. Control of glycated hemoglobin and glycemia. The education level of the participant.

Results Point of Contact

• Title: Isabel de Camargo Neves Sacco
• Organization: University of Sao Paulo

icnsacco@usp.br

+551130918426

Study Officials

• Isabel CN Sacco, PhD

  Associate Professor at São Paulo University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator (allocation, statistics, data processing) and assessor will be blid to the subjects allocation. To evaluate whether or not there was a failure in blinding of the outcome assessor, investigators and other assessors, they will be asked to guess which group the patients belonged to at the end of 8-weeks of treatment. Then the assessors will classify the certainty of their opinions according to a scale (1 = not sure, 5 = completely sure). To ensure that the assessor is not induced to correctly guess the participants' allocation, the patient will be instructed to not disclose any behavior details during the previous 8-weeks.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Assignment

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: November 26, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)