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Completed

NCT Number: NCT06768957

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

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.

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Key information

Conditions

ACL Reconstruction Cognitive Function Single Leg Hop Firm Surface Testing Effect of Intervention

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthosport Centre, Domont, France

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Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Single leg hop for distance

Other

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.

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

Single leg hop for distance plus cognitive task

Other

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.

  • Patient balanced on 1 foot, hands crossed over shoulders.
  • Observe a sequence of 5 digits, appearing every 4 seconds, on the computer in front of you.
  • As soon as the 5th digit appears, jump as far as you can.
  • Stabilise 1 time, keeping your hands on your shoulders.
  • Replay the sequence of 5 numbers that appear on the screen, in reverse order.

Primary outcomes

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

    Time frame: 10 weeks

    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.

Secondary outcomes

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

    Time frame: 10 weeks

    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.

  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.

    Time frame: 10 weeks

    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.

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

    Time frame: 10 weeks

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

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

Sponsors and collaborators

Lead sponsor

Simon VALOT

Other

Registry information

Official study 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.

Acronym: AQQSHTATC

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2025
Registry last updated
Apr 9, 2025

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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