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NeuropathyNCT04467255

Surface Electromyography Study of Fatigue in Diabetic Neuropathy

A study testing Rehabilitative training in people with Neuropathy and Diabetes Mellitus, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Neuropathy, Diabetes Mellitus
What is being tested?
Rehabilitative training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteItaly
Study dates
22 May 2018to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Ics Maugeri

    Montescano, Pavia, 27040

Other trials in Italy

About this study

Official title: Muscular Fatigue Evaluation in Patients With Diabetic Neuropathy by Means of Multichannel Surface Electromyography After a Rehabilitative Training: Aerobic Versus Endurance Training.

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.

Read the 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.

Being tested
Rehabilitative training
Keywords
sEMG, diabetic neuropathy, fatigue, training
Medical subject headings
Diabetes Mellitus, Diabetic Neuropathies, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rehabilitative trainingOther

    4 weeks aerobic treadmill training compared to endurance training with elastic thera band

Study groups in NCT04467255
Study groupRoleWhat they receive
group aActive comparatoraerobic training
Receives: Other: Rehabilitative training
group bActive comparatorendurance training
Receives: Other: Rehabilitative training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Six-minute walk test

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

    Measured: 4 weeks

Secondary outcomes (3)
  1. 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.

    Measured: 4 weeks

  2. 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.

    Measured: 4 weeks

  3. 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).

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2020
  2. Study start22 May 2018
  3. Primary completion16 Jul 2024
  4. Study completion31 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are assigned to two groups in parallel for the duration of the study
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04467255
Sponsor's protocol ID
CE 2185
Status last verified
Sep 2024
First submitted
23 Jun 2020
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22608666
  • 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.

    PubMed 11570119
  • 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.

    PubMed 20630261
  • 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.

    PubMed 23447092

Questions about this trial

What is this clinical trial studying?

A study testing Rehabilitative training in people with Neuropathy and Diabetes Mellitus, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six-minute walk test (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04467255, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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