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Effects of Foot Muscle Strengthening in Daily Activity in Diabetic Neuropathic Patients

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ClinicalTrials.gov Identifier: NCT02790931
Recruitment Status : Recruiting
First Posted : June 6, 2016
Last Update Posted : June 13, 2019
Sponsor:
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 effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Other: Intervention Group Not Applicable

Detailed Description:

A randomized controlled trial will be performed with 77 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no exercises) or an intervention group which will receive 12-week physical therapy exercises, twice a week, under the supervision of a physiotherapist, and twice a week being remotely supervised by a software at home. Every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty.

The subjects will be evaluated in 5 different moments (Baseline, 6 weeks, 12 weeks, 24 weeks and 1 year follow-up)

The hypothesis of this study is that the intervention group will increase daily activity levels, increase self-selected and rapid walking speed, reduce the incidence of plantar ulcers, increase foot health and functionality, improve symptoms, increase tactile and vibration sensitivity, increased passive range of motion, improved quality of life, increased isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group after 12 weeks of intervention and follow-up year.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Foot Muscle Strengthening in Daily Activity, Biomechanics and Functionality of Foot and Ankle in Diabetic Polyneuropathy Patients: a Randomized Controlled Trial
Study Start Date : August 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months.
Other: Intervention Group
Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months, for foot and ankle strengthening, stretching and functional training. They must continue to exercise at home twice a week with the software supervision for one year.
Other Name: Foot and ankle kinesiotherapy

No Intervention: Control Group
Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment.



Primary Outcome Measures :
  1. daily physical activity [ Time Frame: baseline, 12 weeks and 12 months ]
    Calculate the number of steps during 1 week

  2. Self selected gait speed [ Time Frame: baseline,12 weeks and 12 months ]
    self selected gait speed shod walking velocity in a walkway

  3. Fast gait speed [ Time Frame: baseline,12 weeks and 12 months ]
    Fast gait speed shod walking velocity in a walkway


Secondary Outcome Measures :
  1. Risk classification of plantar ulceration [ Time Frame: baseline,6, 12, 24 weeks and 12 months ]
    Score of the classification of the plantar ulcer risk (IWG diabetic foot)

  2. Foot health and functionality [ Time Frame: baseline, 6, 12, 24 weeks and 12 months ]
    Score of the Foot Health Status questionnaire - BRAZIL

  3. Foot strength [ Time Frame: baseline, 6, 12, 24 weeks and 12 months ]
    Hallux and lesser toes force measured by a pressure plate

  4. Foot and ankle Kinematics during gait [ Time Frame: baseline, 12 weeks ]
    Foot joints and plantar arch motion, ankle range of motion, and maximum ankle extension and flexion during gait

  5. Ankle and Knee joint moments and power during gait [ Time Frame: baseline, 12 weeks ]
    Peak joint moment and eccentric and concentric power by inverse dynamic calculations

  6. Incidence of plantar ulcers [ Time Frame: baseline, During 12 months ]
    New cases of plantar ulcers

  7. Tactile sensitivity [ Time Frame: baseline, 6, 12, 24 weeks and 12 months ]
    Evaluation of the tactile sensitivity of four plantar areas with 10g monofilament

  8. Vibration sensitivity [ Time Frame: baseline, 6, 12, 24 weeks and 12 months ]
    Evaluation of the vibration sensitivity with tuning fork

  9. Symptoms [ Time Frame: baseline, 6, 12, 24 weeks and 12 months ]
    Score of the Michigan Neuropathy Screening Instrument questionnaire Michigan Neuropathy Screening Instrument (MNSI)

  10. Range of motion [ Time Frame: baseline, 6, 12, 24 weeks and 12 months ]
    Manual goniometry of the range of motion of flexion and extension of the metatarsophalangeal joint of the hallux and ankle.

  11. EQ-5D score of the quality of life [ Time Frame: baseline, 6, 12, 24 weeks and 12 months ]
    EQ-5D score of the quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 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 polyneuropathy confirmed with the fuzzy software
  • Ability to walk independently in the laboratory
  • Accessibility to electronic devices
  • Loss of at least 4 degrees of ankle range of motion
  • Loss of at least 1 degree of force in the clinical scale of the plantar interosseous or lumbrical muscles

Exclusion Criteria:

  • Ulceration not healed for at least 6 months
  • Hallux amputation or total amputation of the foot
  • Receiving any physiotherapy intervention or offloading devices
  • Neurological or orthopedic impairments
  • Major vascular complications
  • Severe retinopathy

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): NCT02790931


Contacts
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Contact: Isabel CN Sacco, PhD +551130918426 icnsacco@usp.br
Contact: Renan L Monteiro, Ms +5511996166092 renan_montte@hotmail.com

Locations
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Brazil
Universidade de São Paulo Recruiting
São Paulo, Brazil, 05360-160
Contact: Renan L Monteiro, MSc    +5511996166092    renan_montte@hotmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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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):
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Responsible Party: Isabel de Camargo Neves Sacco, Associate Professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02790931     History of Changes
Other Study ID Numbers: LaBiMPH
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Isabel de Camargo Neves Sacco, University of Sao Paulo General Hospital:
diabetic foot
therapeutic exercises
foot
preventive care
rehabilitation
Diabetic Neuropathy

Additional relevant MeSH terms:
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Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases