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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Neuropathies
• Intervention / Treatment: Other: Educational and home-based physical therapy by foot-related exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05360160
      • Érica Queiroz da Silva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; 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.
Experimental: Intervention Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline of the Foot and Ankle Kinematics During Gait at 8-weeks	Sagital plane of ankle range of motion - initial of dorsiflexion until the end of plantaflexion (degrees) during stance phase of gait.	8-weeks
Change From Baseline of the Foot and Ankle Kinetics During Gait at 8-weeks	Peak joint moment of ankle plantarflexor moment at push off during stance phase of gait by inverse dynamic calculations	8-weeks
Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 8-weeks	A pressure platform (emed®-q100, GmbH, Novel Munich, Germany) will be used to evaluate the pressure pattern during walking. The analysis of plantar pressure will be through the parameters: Heel peak pressure (kPa)	8-weeks
Change From Baseline Tactile Sensitivity at 8-weeks	Tactile sensorial deficits will be evaluated by monofilament with a tactile stimulus of a 10-g monofilament in 4 plantar areas (plantar face of the hallux, heads of 1st, 3rd and 5th metatarsals). The areas will be evaluated in random order and not allowing the participant to view the monofilament. The number of areas where the participant does not feel the pressure will be indicated. The greater the number of areas marked without sensing, the greater the impairment of tactile sensitivity.	8-weeks
Change From Baseline Vibration Sensitivity at 8-weeks	The vibration sensitivity will be assessed by vibrating a tuning fork (128Hz) in the dorsal region of the distal hallux phalanx. The participant should report the moment he/she does no longer feel the vibration of the tuning fork, and the evaluator must time the interval between which the participant reports that he/she ceases to feel the vibration and the moment the evaluator ceases to feel the vibration in the his/her hand. Values smaller than 10 seconds will be classified with present vibratory sensitivity; values greater than 10 seconds will be classified as decreased vibratory sensitivity. If the participant does not perceive the vibration imposed by the tuning fork, it will be classified as absent vibratory sensitivity.	8-weeks
Change From Baseline Foot Health and Functionality at 8-weeks	The Brazilian version of the Foot-Health Status Questionnaire (FHSQ-BR) will be used. The domain assessed was function that receives a score from 0 to 100, where 100 expresses the best function and 0 to worst.	8-weeks
Change From Baseline Foot Isometric Strength at 8-weeks	The muscle strength of the flexor muscles of the hallux and flexors of the toes will be evaluated using the emed®-q100 pressure platform (Novel, Germany) according to a test protocol already described elsewhere. The individual should stand, with the evaluated foot centered on the pressure platform, instructed to make as much force as possible with the hallux peak values of maximum force (% of bodyweight).	8-weeks
Change From Baseline Functional Balance at 8-weeks	It is a clinical test where the patient will be standing barefoot, perpendicular to the wall, with the shoulder flexed 90° and the elbow extended. A tape measure will be attached to the wall, parallel to the floor, positioned at the height of the patient's acromion. The volunteer will be instructed to lean forward as much as possible without losing balance or taking a step. The displacement of the wrist will be measured by the tape. The greater the distance in centimeter, the better the functional balance	8-weeks
Change From Baseline of the Foot and Ankle Kinematics During Gait at 16-weeks (Follow-up)	Sagital plane of ankle range of motion - initial of dorsiflexion until the end of plantaflexion (degrees) during stance phase of gait.	16-weeks (Follow-up)
Change From Baseline of the Foot and Ankle Kinetics During Gait at 16-weeks (Follow-up)	Peak joint moment of ankle plantarflexor moment at push off during stance phase of gait by inverse dynamic calculations	16-weeks (Follow-up)
Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 16-weeks (Follow-up)	A pressure platform (emed®-q100, GmbH, Novel Munich, Germany) will be used to evaluate the pressure pattern during walking. The analysis of plantar pressure will be through the parameters: Heel peak pressure (kPa)	16-weeks (Follow-up)
Change From Baseline Tactile Sensitivity at 16-weeks (Follow-up)	Tactile sensorial deficits will be evaluated by monofilament with a tactile stimulus of a 10-g monofilament in 4 plantar areas (plantar face of the hallux, heads of 1st, 3rd and 5th metatarsals). The areas will be evaluated in random order and not allowing the participant to view the monofilament. The number of areas where the participant does not feel the pressure will be indicated. The greater the number of areas marked without sensing, the greater the impairment of tactile sensitivity.	16-weeks (Follow-up)
Change From Baseline Vibration Sensitivity at 16-weeks (Follow-up)	The vibration sensitivity will be assessed by vibrating a tuning fork (128Hz) in the dorsal region of the distal hallux phalanx. The participant should report the moment he/she does no longer feel the vibration of the tuning fork, and the evaluator must time the interval between which the participant reports that he/she ceases to feel the vibration and the moment the evaluator ceases to feel the vibration in the his/her hand. Values smaller than 10 seconds will be classified with present vibratory sensitivity; values greater than 10 seconds will be classified as decreased vibratory sensitivity. If the participant does not perceive the vibration imposed by the tuning fork, it will be classified as absent vibratory sensitivity.	16-weeks (follow-up)
Change From Baseline Foot Health and Functionality at 16-weeks (Follow-up)	The Brazilian version of the Foot-Health Status Questionnaire (FHSQ-BR) will be used. The domain assessed was function and it receives a score from 0 to 100, where 100 expresses the best function and 0 to worst.	16-weeks (Follow-up)
Change From Baseline Foot Isometric Strength at 16-weeks (Follow-up)	The muscle strength of the flexor muscles of the hallux and flexors of the toes will be evaluated using the emed®-q100 pressure platform (Novel, Germany) according to a test protocol already described elsewhere. The individual should stand, with the evaluated foot centered on the pressure platform, instructed to make as much force as possible with the hallux peak values of maximum force (% of bodyweight).	16-weeks (Follow-up)
Change From Baseline Functional Balance at 16-weeks (Follow-up)	It is a clinical test where the patient will be standing barefoot, perpendicular to the wall, with the shoulder flexed 90° and the elbow extended. A tape measure will be attached to the wall, parallel to the floor, positioned at the height of the patient's acromion. The volunteer will be instructed to lean forward as much as possible without losing balance or taking a step. The displacement of the wrist will be measured by the tape. The greater the distance in centimeter, the better the functional balance	16-weeks (Follow-up)

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Isabel CN Sacco, PhD, Associate Professor at São Paulo University

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): November 26, 2021

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: self-management; Primary Health Care; exercise therapy; diabetic foot; preventive care; foot-related exercise; musculoskeletal function; Booklet
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: FOCA-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No