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.
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.
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.
- Conditions
- Neuropathy, Diabetes Mellitus
- 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 group | Role | What they receive |
|---|---|---|
| group a | Active comparator | aerobic training Receives: Other: Rehabilitative training |
| group b | Active comparator | endurance training Receives: Other: Rehabilitative training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted10 Jul 2020
- Study start22 May 2018
- Primary completion16 Jul 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NeuropathyStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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 22608666Chipkin 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 11570119Fritschi 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 20630261Watanabe 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscular Fatigue Evaluation in Patients With Diabetic Neuropathy by Means of Multichannel Surface Electromyography After a Rehabilitative Training: Aerobic Versus Endurance Training.
- ClinicalTrials.gov ID
- NCT04467255
- Acronym / sponsor ID
- CE 2185
- Conditions
- Neuropathy, Diabetes Mellitus
- Keywords
- sEMG, diabetic neuropathy, fatigue, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| group a | Active comparator | Other: Rehabilitative trainingaerobic training |
| group b | Active comparator | Other: Rehabilitative trainingendurance training |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Michigan Neuropathy Screening instrument higher or equal to 7
- Stable clinical conditions
Key exclusion criteria (3 listed)
- Other neurological conditions or diseases
- Skin lesions
- Recent lower limb fractures or lower limb surgical intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitative training4 weeks aerobic treadmill training compared to endurance training with elastic thera band | Other | group a, group b |
Primary outcome
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.
3 secondary outcomes
Modified Borg Scale
Time frame: 4 weeks
Functional Independence Measure
Time frame: 4 weeks
Surface multichannel electromyographic variables.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 22608666Callaghan 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.
- Background: PubMed 11570119Chipkin 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.
- Background: PubMed 20630261Fritschi 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.
- Background: PubMed 23447092Watanabe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.