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Voluntary Activation During Isokinetic Contractions in Subjects With Neuromotor Disorders

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04607174
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Istituto Auxologico Italiano
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Luigi Tesio, MD, Full professor
Principal Investigator Affiliation	Istituto Auxologico Italiano
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis, Poststroke/CVA Hemiparesis, Parkinson Disease, Knee Impairment
Study Website:	View Trial Website

Arms & Interventions

Arms

Other: 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.

Interventions

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.

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International Sites

Istituto Auxologico Italiano, Milan, MI, Italy

Status

Recruiting

Address

Istituto Auxologico Italiano

Milan, MI, 20121

Site Contact

Stefano Scarano, MD, Research Fellow

[email protected]

+39 02 58218717

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