NCT04011267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 3, 2023

Status Verified

February 1, 2023

Enrollment Period

3.1 years

First QC Date

June 11, 2019

Last Update Submit

February 28, 2023

Conditions

Diabetic Neuropathies

Keywords

exercise therapydiabetic footpreventive carefoot-related exercisesself-managementsoftwaremusculoskeletal function

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline Diabetic neuropathy symptoms at 12-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 diabetic neuropathy).

    12-weeks, 24-weeks (follow-up)

  • Change from Baseline of the Fuzzy classification of the diabetic neuropathy severity at 12-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, 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.

    12-weeks, 24-weeks (follow-up)

Secondary Outcomes (10)

  • Change from Baseline of the foot and ankle kinematics during gait at 12-weeks

    12-weeks, 24-weeks (follow-up)

  • Change from Baseline of the foot-ankle joint moment during gait at 12-weeks

    12-weeks, 24-weeks (follow-up)

  • Change from Baseline Dynamic Plantar Pressure Distribution during gait at 12-weeks

    12-weeks, 24-weeks (follow-up)

  • Change from Baseline Tactile sensitivity at 12-weeks

    12-weeks, 24-weeks (follow-up)

  • Change from Baseline Vibration sensitivity at 12-weeks

    12-weeks, 24-weeks (follow-up)

  • +5 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients in the intervention group will perform foot-related exercises described in the SOPeD software three times/week at home via web-software. In the follow-up period, patients will follow the same schedule set by the project till the end of the study.

Other: Physical therapy by foot-ankle segmental and functional 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

Physical therapy by foot-ankle segmental and functional exercisesOTHER

The physiotherapeutic foot-ankle exercise protocol is based on previous clinical trials. It was designed following three criteria established in a supervised, face-to-face intervention: muscle stretching; strengthening of the intrinsic muscles; and strengthening of the extrinsic foot-ankle muscles and functional exercises, such as balance and gait training. To avoid monotony, game principles were inserted to reward the exercise execution and enhance motivation. The exercises change from session to session, and the maximum duration is no longer than 20 minutes. The exercises should only be done 3 times/week; no more than eight exercises each day; and the individual difficulty is regulated by the effort scale to manage the customized progression. In total, 39 different exercises were chosen, and when including their sublevels of progression, a total of 104 different exercises can be completed.

Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 ;
  • Accessibility to electronic devices (computers, mobile devices, tablets, etc.) access to exercise software.

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de São Paulo

São Paulo, 05360-160, Brazil

Location

Related Publications (4)

  • Ferreira JSSP, Cruvinel-Junior RH, da Silva EQ, Verissimo JL, Monteiro RL, Duarte M, Giacomozzi C, Sacco ICN. Effectiveness of a web-based foot-ankle exercise program for treating ulcer risk factors in diabetic neuropathy in a randomized controlled trial. Sci Rep. 2024 Nov 8;14(1):27291. doi: 10.1038/s41598-024-78188-7.

    PMID: 39516524DERIVED

  • Cruvinel-Junior RH, Ferreira JSSP, Verissimo JL, Monteiro RL, Silva EQ, Suda EY, Sacco ICN. Affordable web-based foot-ankle exercise program proves effective for diabetic foot care in a randomized controlled trial with economic evaluation. Sci Rep. 2024 Jul 12;14(1):16094. doi: 10.1038/s41598-024-67176-6.

    PMID: 38997439DERIVED

  • 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.

    PMID: 33766146DERIVED

  • 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.

    PMID: 31931855DERIVED

Related Links

MeSH Terms

Conditions

Diabetic NeuropathiesDiabetic Foot

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Isabel de Camargo Neves Sacco, PhD

    Associate Professor at São Paulo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Single
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 11, 2019

First Posted

July 8, 2019

Study Start

August 1, 2019

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

March 3, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)