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Surface Electromyography Study of Fatigue in Diabetic Neuropathy

Primary Purpose

Neuropathy, Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Rehabilitative training
Sponsored by
Istituti Clinici Scientifici Maugeri SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neuropathy focused on measuring sEMG, diabetic neuropathy, fatigue, training

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ics MaugeriRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group a

group b

Arm Description

aerobic training

endurance training

Outcomes

Primary Outcome Measures

Six-minute walk test
The score of the test is the distance a patient walks in 6 minutes measured in meters.

Secondary Outcome Measures

Modified Borg Scale
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.
Functional Independence Measure
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.
Surface multichannel electromyographic variables.
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).

Full Information

First Posted
June 23, 2020
Last Updated
November 17, 2022
Sponsor
Istituti Clinici Scientifici Maugeri SpA
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1. Study Identification

Unique Protocol Identification Number
NCT04467255
Brief Title
Surface Electromyography Study of Fatigue in Diabetic Neuropathy
Official Title
Muscular Fatigue Evaluation in Patients With Diabetic Neuropathy by Means of Multichannel Surface Electromyography After a Rehabilitative Training: Aerobic Versus Endurance Training.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituti Clinici Scientifici Maugeri SpA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The instrumental session consisted of the registration of sEMG signals during electrically stimulated and voluntary contractions according to a consolidated standardized protocol. The investigated muscle is the Anterior Tibial. Each subjects sat comfortably on a chair with his/her ankle flexed at 90° degree and knee extended; the leg was fixed at 90 degrees, in the isometric brace fixed on a plane (MISO1, LISiN Bioengineering Centre, Turin Polytechnic, Italy Torque was measured with a modular brace incorporating two independent torque transducers (model TR11, CCT Transducers, Torino, Italy). The signal from the two torque meters were amplified, summed and displayed by means of a visual feedback system, which provided the subject with information regarding the torque level produced. Torque signal were stored to be analysed later. The sEMG signal of the right Anterior Tibial was investigated with a flexible adhesive linear array of 16 electrodes (silver bars 10 mm long, 1 mm diameter, 10 mm apart) in single differential (SD) configuration. The optimal position and orientation of the array was determined at moderate contraction levels by visual inspection of the signal. It provided clear motor unit action potentials with similar propagation in the two directions from the neuromuscular junction to the tendons. The reference electrode was positioned on the patient's leg. The skin was cleaned by slightly abrading it with abrasive gel before positioning the array. Since sEMG variables are affected by muscle temperature, the skin temperature was monitored with an electronic thermometer throughout the whole examination and was kept between 31.5 C° and 32.5 C° 30. The protocol consisted in three evaluations: one stimulated contraction and two voluntary contractions, according to a standardized protocol. The stimulated contraction was executed through a button stimulation electrode (size: 10 mm) positioned on the motor point using a monopolar configuration, a frequency of 25 Hz for a duration of 30 seconds and a supramaximal stimulation. The motor point was selected as the position of the stimulated electrode on the skin where the M-wave showed the maximum amplitude for a specified stimulation intensity; the supramaximal stimulation level was defined as the current intensity above which there was no significant increase of the amplitude of the M-wave or the maximum level tolerated by the subjects. A rest period of 10 minutes after stimulation was observed in order to avoid cumulative fatigue phenomenon. The subject then performed two test-contractions by dorsiflexion of the foot against the resistance given by the braces, in order to get acquainted with the procedure and to verify the correct posture and position of the array. The subject was subsequently asked to produce three maximal voluntary contractions (MVC) lasting 3 seconds each with a rest period of 2 minutes in-between. The reference MVC, expressed in Nm, was established as the maximum of the three measurements. The last MVC measurement was followed by a 10-minute rest period. The subject then produced two voluntary contractions each lasting 30 seconds: one contraction at 30% MVC and one at 60% MVC with a 5-minute rest in between. A visual biofeedback was used to help the subject maintaining the requested contraction level; furthermore, the subjects were verbally encouraged to obtain the best outcome during their performance. The EMG signals were filtered with a 10-500 Hz bandwidth filter, amplified (EMG 16-16 channel amplifiers LISiN Bioengineering Centre Turin Polytechnic). They were sampled at 2048 Hz during voluntary contractions and 1024 Hz during electrically elicited contractions. Signals were digitised by a 16 bit A/D converter (DAQCARD-6024E National Instruments, Austin, Texas, USA) and stored on the disk of a personal computer. Signal processing was performed using MATLAB. EMG variables of interest were: mean normalized frequency (MNF), average rectified value (ARV) and muscle fibre conduction velocity (CV). Spectral (i.e. MNF), amplitude (i.e. ARV) and CV variables were computed with numerical algorithms described in previous papers. CV was estimated from the consecutive double differential signals showing the best signal propagation; MNF and ARV were estimated from the single differential channel in the middle of the channels used for CV estimation. Epoch length for EMG variable estimation was 0.5 seconds without overlapping. A linear regression was used to fit all the scatter graphs of the EMG variables with time. The rate of change was defined as the slope of the regression line. The normalized rate of change for all variables was defined as the ratio between the slope and the intercept (initial value of sEMG variables) expressed as percentage. Physiological myoelectric manifestations of muscle fatigue consist in reduction of MNF and CV and increase of ARV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy, Diabetes Mellitus
Keywords
sEMG, diabetic neuropathy, fatigue, training

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to two groups in parallel for the duration of the study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group a
Arm Type
Active Comparator
Arm Description
aerobic training
Arm Title
group b
Arm Type
Active Comparator
Arm Description
endurance training
Intervention Type
Other
Intervention Name(s)
Rehabilitative training
Intervention Description
4 weeks aerobic treadmill training compared to endurance training with elastic thera band
Primary Outcome Measure Information:
Title
Six-minute walk test
Description
The score of the test is the distance a patient walks in 6 minutes measured in meters.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Modified Borg Scale
Description
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.
Time Frame
4 weeks
Title
Functional Independence Measure
Description
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.
Time Frame
4 weeks
Title
Surface multichannel electromyographic variables.
Description
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).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cira Fundarò, MD
Phone
0385247268
Email
cira.fundaro@icsmaugeri.it
Facility Information:
Facility Name
Ics Maugeri
City
Montescano
State/Province
Pavia
ZIP/Postal Code
27040
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cira Fundarò, MD
Phone
0385247268
Ext
0385247268
Email
cira.fundaro@icsmaugeri.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22608666
Citation
Callaghan BC, Cheng HT, Stables CL, Smith AL, Feldman EL. Diabetic neuropathy: clinical manifestations and current treatments. Lancet Neurol. 2012 Jun;11(6):521-34. doi: 10.1016/S1474-4422(12)70065-0. Epub 2012 May 16.
Results Reference
background
PubMed Identifier
11570119
Citation
Chipkin SR, Klugh SA, Chasan-Taber L. Exercise and diabetes. Cardiol Clin. 2001 Aug;19(3):489-505. doi: 10.1016/s0733-8651(05)70231-9.
Results Reference
background
PubMed Identifier
20630261
Citation
Fritschi C, Quinn L. Fatigue in patients with diabetes: a review. J Psychosom Res. 2010 Jul;69(1):33-41. doi: 10.1016/j.jpsychores.2010.01.021. Epub 2010 Mar 23.
Results Reference
background
PubMed Identifier
23447092
Citation
Watanabe K, Gazzoni M, Holobar A, Miyamoto T, Fukuda K, Merletti R, Moritani T. Motor unit firing pattern of vastus lateralis muscle in type 2 diabetes mellitus patients. Muscle Nerve. 2013 Nov;48(5):806-13. doi: 10.1002/mus.23828. Epub 2013 Aug 30.
Results Reference
background

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Surface Electromyography Study of Fatigue in Diabetic Neuropathy

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