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NCT Number: NCT04607174

Voluntary Activation During Isokinetic Contractions in Subjects with Neuromotor Disorders

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Auxologico Italiano

Milan, MI, 20121, Italy

Location status: Recruiting

Location contact

Chiara Malloggi, PhD

CONTACT

Stefano Scarano, MD, Research Fellow

CONTACT

[email protected]

+39 02 58218717

Stefano Scarano, MD, Research Fellow

CONTACT

Viviana Rota, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pathologic group

Other

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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Luigi Tesio, MD, Full Professor

CONTACT

[email protected]

02 58218717

Stefano Scarano, MD, Research Fellow

CONTACT

[email protected]

+39 02 58218717

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

Measuring Voluntary Activation of the Quadriceps Femoris During Isokinetic Concentric Contractions with the Interpolated Twitch Technique (ITT) in Subjects with Neuromotor Disorders

Acronym: ATTILA

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 29, 2020
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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