NCT04607174

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 24, 2024

Status Verified

October 1, 2024

Enrollment Period

4.2 years

First QC Date

October 22, 2020

Last Update Submit

October 22, 2024

Conditions

Keywords

voluntary activationlower limbinterpolated twitch techniquerehabilitation

Outcome Measures

Primary Outcomes (1)

  • Voluntary Activation

    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

Study Arms (1)

Pathologic group

OTHER

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

Interventions

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.

Pathologic group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano

Milan, MI, 20121, Italy

RECRUITING

Related Publications (8)

  • Babault N, Pousson M, Ballay Y, Van Hoecke J. Activation of human quadriceps femoris during isometric, concentric, and eccentric contractions. J Appl Physiol (1985). 2001 Dec;91(6):2628-34. doi: 10.1152/jappl.2001.91.6.2628.

    PMID: 11717228BACKGROUND
  • Behrens M, Husmann F, Gube M, Felser S, Weippert M, Bruhn S, Zschorlich V, Mau-Moeller A. Intersession reliability of the interpolated twitch technique applied during isometric, concentric, and eccentric actions of the human knee extensor muscles. Muscle Nerve. 2017 Aug;56(2):324-327. doi: 10.1002/mus.25498. Epub 2017 Apr 12.

    PMID: 27935064BACKGROUND
  • Behrens M, Mau-Moeller A, Mueller K, Heise S, Gube M, Beuster N, Herlyn PK, Fischer DC, Bruhn S. Plyometric training improves voluntary activation and strength during isometric, concentric and eccentric contractions. J Sci Med Sport. 2016 Feb;19(2):170-6. doi: 10.1016/j.jsams.2015.01.011. Epub 2015 Feb 4.

    PMID: 25766509BACKGROUND
  • Beltman JG, Sargeant AJ, van Mechelen W, de Haan A. Voluntary activation level and muscle fiber recruitment of human quadriceps during lengthening contractions. J Appl Physiol (1985). 2004 Aug;97(2):619-26. doi: 10.1152/japplphysiol.01202.2003. Epub 2004 Apr 9.

    PMID: 15075302BACKGROUND
  • Fitzgerald GK, Piva SR, Irrgang JJ, Bouzubar F, Starz TW. Quadriceps activation failure as a moderator of the relationship between quadriceps strength and physical function in individuals with knee osteoarthritis. Arthritis Rheum. 2004 Feb 15;51(1):40-8. doi: 10.1002/art.20084.

    PMID: 14872454BACKGROUND
  • Zarkou A, Stackhouse S, Binder-Macleod SA, Lee SCK. Comparison of techniques to determine human skeletal muscle voluntary activation. J Electromyogr Kinesiol. 2017 Oct;36:8-15. doi: 10.1016/j.jelekin.2017.05.011. Epub 2017 Jun 8.

    PMID: 28649011BACKGROUND
  • Wilder MR, Cannon J. Effect of age on muscle activation and twitch properties during static and dynamic actions. Muscle Nerve. 2009 May;39(5):683-91. doi: 10.1002/mus.21233.

    PMID: 19229967BACKGROUND
  • Newham DJ, Hsiao SF. Knee muscle isometric strength, voluntary activation and antagonist co-contraction in the first six months after stroke. Disabil Rehabil. 2001 Jun 15;23(9):379-86. doi: 10.1080/0963828001006656.

    PMID: 11394588BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisParkinson Disease

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Luigi Tesio, MD, Full professor

    Istituto Auxologico Italiano

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Tesio, MD, Full Professor

CONTACT

Stefano Scarano, MD, Research Fellow

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 29, 2020

Study Start

October 7, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 24, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Locations