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ACL ReconstructionAQQSHTATCNCT06768957

Test of Return to Sport After ACL Reconstruction and Cognitive Task.

A study testing Single leg hop for distance and Single leg hop for distance plus cognitive task in people with ACL Reconstruction and Cognitive Function, run by Simon VALOT at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

After reconstruction of the anterior cruciate ligament, the aim for the vast majority of sportspeople is to return to the field. To date, 65% of patients who have undergone ACL rehabilitation return to their previous level, and 55% return to competition. Read more about this study

Who is it for?
Ages 16 to 40 yearsHealthy volunteers can take part
What is being tested?
Single leg hop for distance and Single leg hop for distance plus cognitive task
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
4 sitesFrance
Study dates
8 Jan 2025to 2 Apr 2025
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 16 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

The inclusion criteria for the test group (patients with ACL reconstruction) were as follows :

  • Patients with an isolated, unilateral ACL rupture, corresponding to a first injury occurring without contact,
  • Patients who have undergone surgical reconstruction using an autograft of the semitendinosus tendon alone, or an autograft of the semitendinosus tendon and gracilis, or BTB surgery,
  • Patients at 6 +/- 1 months post-operative management,
  • Patients aged between 16 and 40 included,
  • Patients whose level of physical activity, assessed using the Tegner scale, is greater than or equal to 5.

Patients meeting all these inclusion criteria will be included in the study.

Thus, for the test group, the non-inclusion criteria to be taken into account are as follows:

  • Patients with injuries associated with ACL rupture,
  • Patients who have received conservative treatment or who have benefited from another surgical technique,
  • Patients less than 5 months or more than 7 months post-operatively,
  • Patients aged under 16 or over 40,
  • Patients with a Tegner score of less than 5,
  • Patients with recurrent homolateral or controlateral ACL rupture,
  • Patients with an ACL rupture resulting from a direct or indirect impact injury mechanism.

Finally, for the test group, the exclusion criteria to be taken into account are as follows:

  • Refusal to take part in the study,
  • Withdrawal of the participant during the study,
  • Loss of sight of the participant between the two weeks.

For the control group (healthy persons), the inclusion criteria are similar to those for the test group. They correspond to :

  • Persons with no knee trauma in the six months prior to the start of the study,
  • Persons between 16 and 40 years of age included,
  • Persons whose level of physical activity, assessed using the Tegner scale, was greater than or equal to 5.

Persons meeting all these inclusion criteria will be included in the study.

Thus, for the control group, the non-inclusion criteria are as follows:

  • Persons with knee lesions in the six months preceding the start of the study,
  • Persons aged under 16 or over 40,
  • Persons with a Tegner score strictly below 5.

Finally, the exclusion criteria for this group correspond to :

  • Refusal to take part in the study,
  • Retraction of the participant during the study,
  • Loss of vision between the two weeks,
  • Knee trauma between the two weeks.

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Orthosport Centre

    Domont, 95330

  • Physiotherapy practice CESAL

    Les Sables-d'Olonne, 85340

  • Institut de Formation en Masso-Kinésithérapie du Centre Hospitalier Universitaire de Poitiers (physiotherapy training institute)

    Poitiers, 86000

  • Physiotherapy practice MADINI

    Poitiers, 86000

Other trials in France

About this study

Official title: Qualitative and Quantitative Analysis of the "Single Hop Test" Combined With a Cognitive Task, to Optimize Return to Sport After Anterior Cruciate Ligament Reconstruction.

After reconstruction of the anterior cruciate ligament, the aim for the vast majority of sportspeople is to return to the field. To date, 65% of patients who have undergone ACL rehabilitation return to their previous level, and 55% return to competition. To achieve this, physiotherapy sessions need to prepare the return to sport as well as possible, by simulating the cognitive demands (reading the game, double task, etc.) that might be encountered on the pitch. Tests to assess the athlete's performance do exist, in order to optimise this return to sport, but they do not include the cognitive tasks that are present in sport. The high cognitive demands of the sporting environment therefore justify the inclusion of cognitive tasks in these return to sport tests. The aim of this research is to assess the impact of the cognitive task on the performance of a return to sport test following ACL reconstruction. Patients who have undergone ACL reconstruction and healthy subjects will therefore be given a return to sport test called the 'Single Leg Hop for Distance' with and without a cognitive task in order to observe the influence of the cognitive task on the results of the hop.

Including healthy subjects in this study will make it possible to study the impact of the cognitive task in these subjects, who have no neurophysiological dysfunction linked to ACL reconstruction.

The aim of this study is therefore to try to develop the return to sport tests currently described in the literature by proposing a new, improved test that takes account of the cognitive dimension, which is omnipresent in the sporting environment.

Being tested
Single leg hop for distance, Single leg hop for distance plus cognitive task

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single leg hop for distanceOther

    Patients will have to perform a Single leg hop for distance.

    A 10-minute warm-up is required beforehand, followed by three single-leg hop round trips over a distance of 6m to ensure that they are able to perform the exercise.

    You start on the healthy side to understand the principles and reassure yourself. The distance covered is measured. This tells us something about the strength of the lower limb. The landing should be assessed qualitatively.

    1. Patient balanced on 1 foot, hands crossed over shoulders. 2. Jump as far as possible.
    2. Stabilise 1 time, keeping hands on shoulders.

  • Single leg hop for distance plus cognitive taskOther

    Patients were asked to perform a single leg hop for distance in addition to a cognitive task.

    A 10-minute warm-up is required beforehand, followed by three single-leg hop round trips over a distance of 6m to ensure that they are able to perform the exercise.

    You start on the healthy side to understand the principles and reassure yourself. The distance covered is measured. This tells us something about the strength of the lower limb. The landing should be assessed qualitatively.

    1. Patient balanced on 1 foot, hands crossed over shoulders.
    2. Observe a sequence of 5 digits, appearing every 4 seconds, on the computer in front of you.
    3. As soon as the 5th digit appears, jump as far as you can.
    4. Stabilise 1 time, keeping your hands on your shoulders.
    5. Replay the sequence of 5 numbers that appear on the screen, in reverse order.
Study groups in NCT06768957
Study groupRoleWhat they receive
Control group: SLHD then SLHD with cognitive taskExperimentalThis control group, made up of healthy subjects, will perform a single leg hop for distance and then one week later will perform a single leg hop for distance plus a cognitive task. Intervention 1 administered : Other: Single leg hop for distance. Intervention 2 administered : Other: Single leg hop for distance plus cognitive task.
Receives: Other: Single leg hop for distance; Other: Single leg hop for distance plus cognitive task
Control group: SLHD with cognitive task then SLHDExperimentalThis control group, made up of healthy subjects, will perform a single leg hop for distance plus a cognitive task and then one week later will perform a single leg hop for distance. Intervention 1 administered : Other: Single leg hop for distance plus cognitive task Intervention 2 administered : Other: Single leg hop for distance
Receives: Other: Single leg hop for distance; Other: Single leg hop for distance plus cognitive task
Control group: SLHD then SLHDExperimentalThis control group, made up of healthy subjects, will perform a single leg hop for distance and then one week later will perform another single leg hop for distance. Intervention 1 administered : Other: Single leg hop for distance Intervention 2 administered : Other: Single leg hop for distance
Receives: Other: Single leg hop for distance
Control group: SLHD with cognitive task then SLHD with cognitive taskExperimentalThis control group, made up of healthy subjects, will perform a single leg hop for distance plus a cognitive task and then one week later will perform another single leg hop for distance plus a cognitive task. Intervention 1 administered : Other: Single leg hop for distance plus cognitive task Intervention 2 administered : Other: Single leg hop for distance plus cognitive task
Receives: Other: Single leg hop for distance plus cognitive task
Test group: SLHD then SLHD with cognitive taskExperimentalThis test group, made up of patients who have undergone ACL reconstruction, will perform a single leg hop for distance and then one week later will perform a single leg hop for distance plus a cognitive task. Intervention 1 administered : Other: Single leg hop for distance. Intervention 2 administered : Other: Single leg hop for distance plus cognitive task.
Receives: Other: Single leg hop for distance; Other: Single leg hop for distance plus cognitive task
Test group: SLHD with cognitive task then SLHDExperimentalThis test group, made up of patients who have undergone ACL reconstruction, will perform a single leg hop for distance plus a cognitive task and then one week later will perform a single leg hop for distance. Intervention 1 administered : Other: Single leg hop for distance plus cognitive task Intervention 2 administered : Other: Single leg hop for distance
Receives: Other: Single leg hop for distance; Other: Single leg hop for distance plus cognitive task
Test group: SLHD then SLHDExperimentalThis test group, made up of patients who have undergone ACL reconstruction, will perform a single leg hop for distance and then one week later will perform another single leg hop for distance. Intervention 1 administered : Other: Single leg hop for distance Intervention 2 administered : Other: Single leg hop for distance
Receives: Other: Single leg hop for distance
Test group: SLHD with cognitive task then SLHD with cognitive taskExperimentalThis test group, made up of patients who have undergone ACL reconstruction, will perform a single leg hop for distance plus a cognitive task and then one week later will perform another single leg hop for distance plus a cognitive task. Intervention 1 administered : Other: Single leg hop for distance plus cognitive task Intervention 2 administered : Other: Single leg hop for distance plus cognitive task
Receives: Other: Single leg hop for distance plus cognitive task

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessing the impact of the cognitive task on quantitative performance (jumping distance measured in meters) after ACL reconstruction.

    Quantitative assessment of performance, using the Single Leg Hop for Distance, depending on whether or not a cognitive test is present.

    Measurement of jump distance in meters.

    Measured: 10 weeks

Secondary outcomes (3)

  1. Assessing the impact of the cognitive task on qualitative performance after ACL reconstruction with Qualitative Analysis of Single Leg Score.

    Qualitative evaluation of the Single Leg Hop for Distance using Qualitative Analysis of Single Leg Score (QASLS), according to the presence or absence of a cognitive test.

    We use the Qualitative Analysis of Single Leg Score to evaluate the performance.

    Measured: 10 weeks

  2. Assess the impact of the cognitive task on qualitative jumping performance after ACL reconstruction and in healthy subjects, with Qualitative Analysis of Single Leg Score.

    Comparison of qualitative (Qualitative Analysis of Single Leg Score) jump performance between the two populations.

    We compare the Qualitative Analysis of Single Leg Score between the two population.

    Measured: 10 weeks

  3. Assess the impact of the cognitive task on quantitative (distance measured in meters) jumping performance after ACL reconstruction and in healthy subjects.

    Comparison of quantitative (distance in meters) jump performance between the two populations.

    We compare the jump distances measured in meters between the two populations.

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2025
  2. Study start8 Jan 2025
  3. Primary completion28 Mar 2025
  4. Study completion2 Apr 2025

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two groups are present in parallel: * A control group (healthy volunteers). * A test group (patients who have undergone ACL reconstruction). Several sub-groups are present within these groups in order to carry out a crossover study.
Masking
Single blind
Who is masked
Participant
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06768957
Sponsor's protocol ID
2024-A02038-39
Acronym
AQQSHTATC
Status last verified
Apr 2025
First submitted
30 Dec 2024
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Parry GN, Herrington LC, Munro AG. Reliability and Measurement Error of the Qualitative Analysis of Single Leg Loading (QASLS) Tool For Unilateral Tasks. Int J Sports Phys Ther. 2023 Oct 1;18(5):1136-1146. doi: 10.26603/001c.88007. eCollection 2023.

    PubMed 37885771

  • Li ZI, Green JS, Chalem I, Triana J, Rao N, Hughes AJ, Campbell KA, Jazrawi LM, Medvecky MJ, Alaia MJ. Patient-reported outcomes and return to pre-injury activities after surgical treatment of multi-ligamentous knee injuries in patients over 40-years-old: Average 5-years follow-up. Knee. 2024 Jan;46:89-98. doi: 10.1016/j.knee.2023.11.014. Epub 2023 Dec 8.

    PubMed 38070381

  • Hecker A, Schmaranzer F, Huber C, Maurer J, Egli RJ, Eberlein SC, Klenke FM. Treatment of Knee Dislocation With Primary Repair and Suture Augmentation: A Viable Solution. Orthop J Sports Med. 2022 Nov 17;10(11):23259671221132555. doi: 10.1177/23259671221132555. eCollection 2022 Nov.

    PubMed 36425010

  • Berk AN, Piasecki DP, Fleischli JE, Trofa DP, Saltzman BM. Trends in Patient-Reported Outcomes After Anterior Cruciate Ligament Reconstruction: A Systematic Review. Orthop J Sports Med. 2023 May 31;11(5):23259671231174472. doi: 10.1177/23259671231174472. eCollection 2023 May.

    PubMed 37284137

  • Zhou W, Liu X, Hong Q, Wang J, Luo X. Association between passing return-to-sport testing and re-injury risk in patients after anterior cruciate ligament reconstruction surgery: a systematic review and meta-analysis. PeerJ. 2024 Apr 29;12:e17279. doi: 10.7717/peerj.17279. eCollection 2024.

    PubMed 38699196

  • Aizawa JY, Hirohata K, Ohji S, Mitomo S, Ohmi T, Koga H, Yagishita K. Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) subcategories are affected by subjective running ability and medial single-leg hop distance in postreconstruction patients at 6 months. J Exp Orthop. 2024 Feb 3;11(1):e12004. doi: 10.1002/jeo2.12004. eCollection 2024 Jan.

    PubMed 38455451

  • Measson MV, Ithurburn MP, Rambaud AJ. Intra-rater Reliability of a Qualitative Landing Scale for the Single-Hop Test: A Pilot Study. Int J Sports Phys Ther. 2022 Apr 1;17(3):493-500. doi: 10.26603/001c.33066. eCollection 2022.

    PubMed 35391866

  • Kiani Haft Lang M, Mofateh R, Orakifar N, Goharpey S. Differences in Neurocognitive Functions Between Healthy Controls and Anterior Cruciate Ligament-Reconstructed Male Athletes Who Passed or Failed Return to Sport Criteria: A Preliminary Study. J Sport Rehabil. 2023 Apr 25;32(6):645-654. doi: 10.1123/jsr.2022-0288. Print 2023 Aug 1.

    PubMed 37185456

  • Riera J, Forelli F, Coulondre C, Rambaud A. Fiche pratique du " Single Hop Test ". J Traumatol Sport. 1 mars 2023;40(1):46-8.

  • Kotsifaki R, Korakakis V, King E, Barbosa O, Maree D, Pantouveris M, Bjerregaard A, Luomajoki J, Wilhelmsen J, Whiteley R. Aspetar clinical practice guideline on rehabilitation after anterior cruciate ligament reconstruction. Br J Sports Med. 2023 May;57(9):500-514. doi: 10.1136/bjsports-2022-106158. Epub 2023 Feb 2.

    PubMed 36731908

  • Valot S, Moiroux-Sahraoui A, Cerrito A, Forelli F. Dual-Task Single-Leg Hop Performance Exposes Persistent Asymmetry and Movement Deficits After Anterior Cruciate Ligament Reconstruction: A Randomised Crossover Experimental Study. Transl Sports Med. 2026 Jul 15;2026:5079279. doi: 10.1155/tsm2/5079279. eCollection 2026.

    PubMed 42459209

Questions about this trial

What is this clinical trial studying?

A study testing Single leg hop for distance and Single leg hop for distance plus cognitive task in people with ACL Reconstruction and Cognitive Function, run by Simon VALOT at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. 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?

Assessing the impact of the cognitive task on quantitative performance (jumping distance measured in meters) after ACL reconstruction. (time frame: 10 weeks). 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 NCT06768957, which also lists 11 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 9 Apr 2025.

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