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Surface Electromyography Study of Fatigue in Diabetic Neuropathy

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: NCT04467255
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Istituti Clinici Scientifici Maugeri SpA

Brief Summary:
Fatigue in diabetic neuropathy compromises patients' physical activity and poses questions on how to plan correct rehabilitation training. Conclusive interpretation of muscular mechanisms of fatigue in diabetic neuropathy has not yet been achieved. Among the various instrumental evaluations for fatigue, multichannel surface electromyography (sEMG) is a recognized tool that permits the study of myoelectric manifestations of fatigue. Aim of the study is to assess if differences in myoelectric manifestations of fatigue between patients affected by diabetic neuropathy exist after an aerobic or endurance training.

Condition or disease Intervention/treatment Phase
Neuropathy Diabetes Mellitus Other: Rehabilitative training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to two groups in parallel for the duration of the study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Muscular Fatigue Evaluation in Patients With Diabetic Neuropathy by Means of Multichannel Surface Electromyography After a Rehabilitative Training: Aerobic Versus Endurance Training.
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: group a
aerobic training
Other: Rehabilitative training
4 weeks aerobic treadmill training compared to endurance training with elastic thera band

Active Comparator: group b
endurance training
Other: Rehabilitative training
4 weeks aerobic treadmill training compared to endurance training with elastic thera band




Primary Outcome Measures :
  1. Six-minute walk test [ Time Frame: 4 weeks ]
    The score of the test is the distance a patient walks in 6 minutes measured in meters.


Secondary Outcome Measures :
  1. Modified Borg Scale [ Time Frame: 4 weeks ]
    Is is commonly used to assess fatigue during a training expressed with Dyspnea. This is a0 to 10 rated scale. High score corresponds to worse outcome.

  2. Functional Independence Measure [ Time Frame: 4 weeks ]
    The functional Independence measure is an 18-item measurement tool that explores an individual's physical, psychological and social function. The tool is used to assess a patient's level of disability. Range total score 18-126. High score corresponds to better outcome.

  3. Surface multichannel electromyographic variables. [ Time Frame: 4 weeks ]
    In research setting muscle electric properties were analyzed during contractions employing multichannel surface electromyograpy. Among the variables describing muscle activity, we examine conduction velocity. The conduction velocity of the muscle was estimated from the difference in arrival time of the motor unit potential at electrodes separeted by 15 mm. The motor unit conduction velocity for anterior tibial, analyzed in this study, ranged from 2.6 to 5.3 m/s (mean 3.7 m/s) (Arendt-Nielsen SA and L. J Physiol (1987), 391, pp 561-571).



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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Michigan Neuropathy Screening instrument higher or equal to 7
  • Stable clinical conditions

Exclusion Criteria:

  • Other neurological conditions or diseases
  • Skin lesions
  • Recent lower limb fractures or lower limb surgical intervention

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): NCT04467255


Contacts
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Contact: Cira Fundarò, MD 0385247268 cira.fundaro@icsmaugeri.it

Locations
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Italy
Ics Maugeri Recruiting
Montescano, Pavia, Italy, 27040
Contact: Cira Fundarò, MD    0385247268 ext 0385247268    cira.fundaro@icsmaugeri.it   
Sponsors and Collaborators
Istituti Clinici Scientifici Maugeri SpA
Publications:
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Responsible Party: Istituti Clinici Scientifici Maugeri SpA
ClinicalTrials.gov Identifier: NCT04467255    
Other Study ID Numbers: 2185
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituti Clinici Scientifici Maugeri SpA:
sEMG, diabetic neuropathy, fatigue, training
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Fatigue
Signs and Symptoms
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases