Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04008745
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Isabel de Camargo Neves Sacco, University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Other: Educational and home-based physical therapy by foot-related exercises Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.



Primary Outcome Measures :
  1. Change from Baseline Diabetic neuropathy symptoms at 8-weeks [ Time Frame: 8-weeks, 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).

  2. Change from Baseline of the Fuzzy classification of the diabetic neuropathy severity at 8-weeks [ Time Frame: 8-weeks, 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.


Secondary Outcome Measures :
  1. Change from Baseline of the foot and ankle kinematics during gait at 8-weeks [ Time Frame: 8-weeks, 16-weeks (Follow-up) ]
    Ankle & Foot joints and plantar arch motion: maximum, minimum and range of motion (degrees) during gait.

  2. Change from Baseline of the foot and ankle kinetics during gait at 8-weeks [ Time Frame: 8-weeks, 16-weeks (Follow-up) ]
    maximum foot and ankle joint moments and power, calculated by inverse dynamics using kinematics and ground reaction force during gait.

  3. Change from Baseline dynamic Plantar Pressure Distribution during gait at 8-weeks [ Time Frame: 8-weeks, 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: peak pressure (kPa), pressure - time integral (kPa/s) in each plantar area.

  4. Change from Baseline Tactile sensitivity at 8-weeks [ Time Frame: 8-weeks, 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.

  5. Change from Baseline Vibration sensitivity at 8-weeks [ Time Frame: 8-weeks, 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.

  6. Change from Baseline Foot health and functionality at 8-weeks [ Time Frame: 8-weeks, 16-weeks (Follow-up) ]
    The Brazilian version of the Foot-Health Status Questionnaire (FHSQ-BR) will be used. This instrument is divided into three domains and we are using domains I and II. The first domain evaluates the foot in four spheres: pain, function, footwear and general health. The second domain evaluates the general state of health, also in four spheres: general health, physical activity, social capacity and vitality. Domains I and II are composed of questions with answer choices that are presented in the affirmative sentences and corresponding numbers. Domain III, which is not being used, comprises the collection of general demographic data of individuals. Each domain receives a score from 0 to 100, where 100 expresses the best condition and 0 to worst.

  7. Change from Baseline Foot isometric strength at 8-weeks [ Time Frame: 8-weeks, 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 and toes in order to press them against the platform ("squeeze the platform with the toes"). Peak values of maximum force (N) will be extracted. The values will be normalized by bodyweight.

  8. Change from Baseline Functional balance at 8-weeks [ Time Frame: 8-weeks, 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008745


Contacts
Layout table for location contacts
Contact: Isabel CN Sacco, PhD +551130918426 icnsacco@usp.br
Contact: Érica Q Silva, MSc +5511985492016 ericaqueiroz10@usp.br

Locations
Layout table for location information
Brazil
Érica Queiroz da Silva Recruiting
São Paulo, SP, Brazil, 05360160
Contact: Erica Q Silva, MSc    +5511985492016    ericaqueiroz10@usp.br   
Contact: Jane P Ferreira, MSc    +5511941476839    janesuelen@yahoo.com.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Layout table for investigator information
Principal Investigator: Isabel CN Sacco, PhD Associate Professor at São Paulo University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Isabel de Camargo Neves Sacco, Associate Professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04008745    
Other Study ID Numbers: FOCA-II
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Isabel de Camargo Neves Sacco, University of Sao Paulo General Hospital:
exercise therapy
diabetic foot
preventive care
foot-related exercise
self-management
musculoskeletal function
Booklet
Primary Health Care
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases