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Voluntary Activation During Isokinetic Contractions in Subjects With Neuromotor Disorders (ATTILA)

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ClinicalTrials.gov Identifier: NCT04607174
Recruitment Status : Recruiting
First Posted : October 29, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Luigi Tesio, Prof, Istituto Auxologico Italiano

Brief Summary:

Activation is the amount of voluntary recruitment of a muscle during voluntary contraction. Full activation implies the recruitment of all muscle fibres at their tetanic frequency. In healthy subjects, and even in sports performances, full activation may be rarely achieved despite a subjectively maximal effort.

Highly decreased activation has been observed in patients affected by various orthopaedic and neurological disorders. In these subjects, paresis may be caused or aggravated by primitive impairments of the central nervous system and/or, by stimuli arising from peripheral damaged tissues that inhibit the corticospinal or the intraspinal recruitment of motoneurones ("arthrogenous muscle weakness"). There are numerous investigations in the literature on activation measured during isometric contractions, while they are substantially missing as far as isokinetic concentric contractions are concerned. There are reasons to suppose that, contrary to what has been demonstrated for healthy subjects, in patients with various motor impairments the activation is diminished the more, the higher is the joint rotation speed.

The present study aims to investigate the amount of activation of the quadriceps femoris during subjectively maximal isometric contractions at 40° knee flexion (0°=complete extension) and isokinetic concentric contractions at an angular velocity of 100°/s in patients with various orthopaedic and neurologic conditions.

Activation will be measured on an isokinetic dynamometer, through the "interpolated twitch technique". This consists of stimulating a representative sample of the muscle belly through an electric shock. If the shock does not generate an extra force during contraction, all muscle fibres belonging to the sample reached by the electric shock can be claimed to be recruited at their tetanic frequency. Otherwise, following the stimulus, a twitch can be observed revealing submaximal voluntary recruitment of the muscle.


Condition or disease Intervention/treatment
Multiple Sclerosis Poststroke/CVA Hemiparesis Parkinson Disease Knee Impairment Other: Pathologic group

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring Voluntary Activation of the Quadriceps Femoris During Isokinetic Concentric Contractions With the Interpolated Twitch Technique (ITT) in Subjects With Neuromotor Disorders
Actual Study Start Date : October 7, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pathologic group
At least 20 participants with various neurologic or orthopaedic conditions (for example, hemiparesis post-stroke, multiple sclerosis, traumatic knee injuries, knee osteoarthritis) will be enrolled.
Other: Pathologic group

Voluntary Activation level will be determined according to the interpolate twitch technique (ITT).

During isometric contractions (knee at 40° flexion), three electric shocks (doublets) will be delivered. The first shock will be delivered at rest before contraction. The second one will be delivered 3-4 s after the beginning of the effort. The third one will be delivered at rest 2-3 s after the contraction has ended. Two isometric contractions will be performed, with a 3-minute break.

Then, 3 consecutive continuous passive motion (CPM) extension-flexions of the knee joint (range 105-0°), and 3 isokinetic concentric contractions (ISOK) will be performed. During both CPM and ISOK an electric shock will be delivered during each repetition. The instant of stimulation will be determined in a way allowing the twitch moments to peak at exactly 40° of knee flexion during extension. The same procedure will be administered first to the affected limb, and then to the non-affected limb.





Primary Outcome Measures :
  1. Voluntary Activation [ Time Frame: Day 1 ]
    Voluntary Activation = [1 - (Interpolated Twitch/Resting Twitch)]%, where Interpolated Twitch and Resting Twitch are the peak torques caused by the electric shock during the voluntary contraction and a rest, respectively



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subjects will be recruited in the proposing Operational Unit on an outpatient basis, from a physiatric referral or from an inpatient rehabilitation unit.
Criteria

Inclusion Criteria:

  • age between 18 and 70 years old;
  • ability to sign the informed consent form;
  • ability to understand the instructions and to complete the motor task;
  • voluntary knee flexion-extension range of at least 70°;
  • maximal extension of angle < 30° (0°=full extension, 180° sagittal tibio-femural angle).

Exclusion Criteria:

  • pregnancy;
  • a history of epilepsy (to avoid the risk for seizures triggered by the stimuli);
  • Mini Mental State Examination ≤27/30;
  • implanted electro-sensitive devices;
  • any orthopedic condition limiting the articular mobility or muscular strength of the lower limbs;
  • current treatment with oral anticoagulant or antiplatelet therapy (to avoid the risk for muscle hemorrhage;
  • medium/serius osteoporosis (femoral Bone Mineral Density on the affected side, t-score < (-3.5));
  • familiarity with the testing method.

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): NCT04607174


Contacts
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Contact: Luigi Tesio, MD, Full Professor 02 58218717 l.tesio@auxologico.it
Contact: Stefano Scarano, MD, Research Fellow +39 02 58218717 s.scarano@auxologico.it

Locations
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Italy
Istituto Auxologico Italiano Recruiting
Milan, MI, Italy, 20121
Contact: Stefano Scarano, MD, Research Fellow    +39 02 58218717    s.scarano@auxologico.it   
Sub-Investigator: Chiara Malloggi, PhD         
Sub-Investigator: Viviana Rota, PhD         
Sub-Investigator: Stefano Scarano, MD, Research Fellow         
Sponsors and Collaborators
Istituto Auxologico Italiano
Investigators
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Principal Investigator: Luigi Tesio, MD, Full professor Istituto Auxologico Italiano
Additional Information:
Publications:

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Responsible Party: Luigi Tesio, Prof, MD, Director of the Department of Neuromotor Rehabilitation, Ospedale San Luca, Istituto Auxologico Italiano, IRCCS; Full Professor, Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy, Istituto Auxologico Italiano
ClinicalTrials.gov Identifier: NCT04607174    
Other Study ID Numbers: 24C903
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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 Luigi Tesio, Prof, Istituto Auxologico Italiano:
voluntary activation
lower limb
interpolated twitch technique
rehabilitation
Additional relevant MeSH terms:
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Parkinson Disease
Multiple Sclerosis
Paresis
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurologic Manifestations