Multiple SclerosisATTILANCT04607174
Voluntary Activation During Isokinetic Contractions in Subjects With Neuromotor Disorders
A study testing Pathologic group in people with Multiple Sclerosis and Poststroke/CVA Hemiparesis, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Poststroke/CVA Hemiparesis, Parkinson Disease
- What is being tested?
- Pathologic group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 7 Oct 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Pathologic group
- Keywords
- voluntary activation, lower limb, interpolated twitch technique, rehabilitation
- Medical subject headings
- Multiple Sclerosis, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathologic groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pathologic group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start7 Oct 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Tesio, Prof, Istituto Auxologico Italiano
- Investigators
- Luigi Tesio, MD, Full professor, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607174
- Sponsor's protocol ID
- 24C903
- Acronym
- ATTILA
- Status last verified
- May 2025
- First submitted
- 22 Oct 2020
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 11717228Behrens 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.
PubMed 27935064Behrens 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.
PubMed 25766509Beltman 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.
PubMed 15075302Fitzgerald 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.
PubMed 14872454Zarkou 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.
PubMed 28649011Wilder 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.
PubMed 19229967Newham 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.
PubMed 11394588
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Voluntary Activation of the Quadriceps Femoris During Isokinetic Concentric Contractions With the Interpolated Twitch Technique (ITT) in Subjects With Neuromotor Disorders
- ClinicalTrials.gov ID
- NCT04607174
- Acronym / sponsor ID
- ATTILA / 24C903
- Keywords
- voluntary activation, lower limb, interpolated twitch technique, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pathologic group | Other | Other: Pathologic groupAt least 20 participants with various neurologic or orthopaedic conditions (for example, hemiparesis post-stroke, multiple sclerosis, traumatic knee injuries, knee osteoarthritis) will be enrolled. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pathologic groupVoluntary 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. | Other | Pathologic group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 11717228Babault 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.
- Background: PubMed 27935064Behrens 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.
- Background: PubMed 25766509Behrens 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.
- Background: PubMed 15075302Beltman 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.
- Background: PubMed 14872454Fitzgerald 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.
- Background: PubMed 28649011Zarkou 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.
- Background: PubMed 19229967Wilder 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.
- Background: PubMed 11394588Newham 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Tesio, MD, Full professor principal investigator
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pathologic group in people with Multiple Sclerosis and Poststroke/CVA Hemiparesis, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voluntary Activation (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04607174, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.