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

March 14, 2024 updated by: Luigi Tesio, Prof, Istituto Auxologico Italiano

Measuring Voluntary Activation of the Quadriceps Femoris During Isokinetic Concentric Contractions With the Interpolated Twitch Technique (ITT) 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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • MI
      • Milan, MI, Italy, 20121
        • Recruiting
        • Istituto Auxologico Italiano
        • Contact:
        • Sub-Investigator:
          • Chiara Malloggi, PhD
        • Sub-Investigator:
          • Viviana Rota, PhD
        • Sub-Investigator:
          • Stefano Scarano, MD, Research Fellow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Luigi Tesio, MD, Full professor, Istituto Auxologico Italiano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2020

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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