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Muscle Tone AbnormalitiesNCT05070780

Neurophysiological Evaluation of Muscle Tone

An observational study of Muscle Tone Abnormalities and Rigidity, Muscle, run by Neuromed IRCCS at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective of this study is to apply a biomechanical system (the NeuroFlexor) associated with the EMG recording to study the physiological mechanisms that contribute to the regulation of muscle tone in healthy subjects and in patients with increased muscle tone. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Robot-assisted examination
Type of treatment
Medical device
How many people
60 participants
Where
1 siteItaly
Study dates
1 Oct 2021to 31 Dec 2023
Phase
Observational
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Healthy subjects, 20 Patients with rigidity, 20 Patients with spasticity, 20

Who may be able to join

  • Parkinson's disease
  • post-stroke spasticity

Who cannot join

  • degenerative arthrosis
  • rheumatoid arthritis
  • cognitive impairment (MMSE <24)
  • depression and other mood disorders (HAMD> 7)

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting
  • Irccs Neuromed

    Pozzilli, 86077

    Antonio Suppa, PhD, 00390865929600, Antonio.suppa@uniroma1.it

    Francesco Asci, 00390865929600, francesco.asci@uniroma1.it

    Recruiting

Other trials in Italy

About this study

Official title: Neurophysiological Evaluation of Muscle Tone in Healthy Subjects and in Patients With Increased Muscle Tone

The primary objective of this study is to apply a biomechanical system (the NeuroFlexor) associated with the EMG recording to study the physiological mechanisms that contribute to the regulation of muscle tone in healthy subjects and in patients with increased muscle tone. A second fundamental objective of this study is to monitor over time the changes in muscle tone that can be found physiologically in healthy subjects and pathologically in patients with spasticy and/or rigidity. A further objective of this study is the quantitative evaluation of the symptomatic effects of specific therapies in improving the impaired muscle tone.

Clinical evaluation In this research project the investigators will recruit 20 patients with upper limb spasticity (regardless of the underlying disease responsible for the spasticity), 20 patients with Parkinson's disease characterized by stiffness of the upper limbs and 20 healthy control subjects. Patients will be recruited from the IRCCS Neuromed Institute, Pozzilli (IS). Participants will give their written informed consent to the study, which will be approved by the institutional ethics committee of the IRCCS Neuromed Institute, in accordance with the Declaration of Helsinki. All participants will be right-handed according to the Edinburgh handedness inventory (EDI) (Oldfield, 1971). Parkinson's disease will be diagnosed in accordance with the updated diagnostic criteria of the MDS (Postuma, RB et al. Validation of the MDS clinical diagnostic criteria for Parkinson's disease. Mov. Disord. Off. J. Mov. Disord. Soc. 33, 1601 -1608 (2018)., Nd). Clinical signs and symptoms of parkinsonian patients will be evaluated using the Hoehn \& Yahr scale (H\&Y), UPDRS part III (Patrick et al., 2001). The diagnosis of spasticity will be made through the neurological clinical evaluation of the patients and on the basis of the specific clinical history of the various pathologies underlying the spasticity itself (e.g. multiple sclerosis, stroke, spinal injuries). Spasticity will be assessed with the Modified Ashworth Scale "(MAS) (Harb and Kishner, 2021), the Modified Tardieu scale (MTS) (Patrick and Ada, 2006). Cognitive functions and mood, in both pathological conditions, will be evaluated using the clinical Mini-Mental State Evaluation (MMSE) scale (Folstein et al., 1975) and the Hamilton Depression Rating Scale (HAM_D) ( Hamilton, 1967). No participant must report pain problems and / or functional limitations affecting the upper limbs.

Read more

Exclusion criteria: - insufficient degree of passive wrist movement (<30 ° in flexion and <40 ° in extension) - tension at rest during NeuroFlexor recordings - hand pathologies (neurological or rheumatological) - upper limb fractures in the previous six months - presence of peacemakers or other stimulators - pregnancy.

All patients, and the group of healthy control subjects will have comparable anthropometric and demographic characteristics.

Experimental paradigm Participants will be seated comfortably, with the shoulder at 45 ° of abduction, the elbow at 90 ° in flexion, the forearm in pronation and the dominant hand placed on the platform of the Neuroflexor device. Participants will be instructed to relax during the test session, which will consist of the passive extension of the wrist at 7 speeds, one slow (5 ° / s) and 6 rapid (50 ° / s, 100 ° / s, 150 ° / s, 200 ° / s, 236 ° / s, 280 ° / s). The total range of wrist movement will be 50 °, starting from an initial angle of 20 ° in palmar flexion up to 30 ° in extension. Before the start of the experiment, participants will do practical tests in order to become familiar with the device. Two slow and five rapid movements will be made for each speed. The different angular velocities of wrist mobilization will be randomized. Slow movements will be performed before fast movements with an interval of 10 seconds between each test. For each participant, a NC, EC and VC value in Newton will be calculated by a dedicated software. The resistance profiles will also be obtained when the device was running idle (without hand) to allow the biomechanical model to isolate the forces originating from the hand from the intrinsic forces of the device. For each movement, the corresponding surface EMG trace will have been recorded, by placing the electrodes on the skin overlying the belly of the FRC and ERC muscles. An accelerometer, fixed on the back of the hand of the limb to be examined, will be used to synchronize the electromyograph with the NeuroFlexor. The EMG activity recorded by means of surface electrodes with belly-tendon type mounting, will be amplified using the Digitimer, will then be digitized at 5 kHz using the CED, and finally it will be stored on a computer dedicated to offline analysis. EMG recordings will be made at 6 speeds, 50°/ s, 100°/ s, 150°/ s, 200 °/s, 236 °/s, 280 °/s. For each trace the following parameters will be analyzed: latency, peak-to-peak amplitude and area of the EMG response.

Being tested
Robot-assisted examination
Medical subject headings
Muscle Rigidity, Muscle Spasticity

What participants receive

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

  • Robot-assisted examinationDevice

    evaluation of muscle tone with Robot-assisted perturbation

Study groups in NCT05070780
Study groupRoleWhat they receive
Healthy SubjectsNot described
Receives: Device: Robot-assisted examination
Patients with rigidityNot described
Receives: Device: Robot-assisted examination
Patients with spasticityNot described
Receives: Device: Robot-assisted examination

What is being measured

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

  1. Analysis of biomechanical properties of muscles

    total force

    Measured: 100 milliseconds

Timeline

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

  1. First posted7 Oct 2021
  2. Study start1 Oct 2021
  3. Primary completion30 Dec 2022
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05070780
Sponsor's protocol ID
NEUR_02
Status last verified
Mar 2023
First submitted
27 Sep 2021
Last updated
22 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Muscle Tone Abnormalities and Rigidity, Muscle, run by Neuromed IRCCS 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 4 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: status not confirmed, as of the sponsor's last update on 22 Mar 2023. 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?

Results are not available in the source record.

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

Contact Antonio Suppa, MD, PhD (+00393494940365, antonio.suppa@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analysis of biomechanical properties of muscles (time frame: 100 milliseconds). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 22 Mar 2023.

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