Anterior Cruciate Ligament ReconstructionAMIRANCT06206200
The Effects of Cognitive Dual-Tasking in Later Stages of Rehabilitation After ACL Reconstruction
A study testing Cognitive dual task training (intervention group) in people with Anterior Cruciate Ligament Reconstruction and Athrogenic Muscle Responses, run by University Ghent at 1 site in Belgium.
Trial summary
Anterior cruciate ligament (ACL) injuries are common in sports and often require a long and challenging rehabilitation process. Athletes who sustain these injuries typically engage in pivoting and cutting sports, where these motor tasks must be performed simultaneously with cognitive tasks such as decision-making and… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction, Athrogenic Muscle Responses, ACL Injury
- What is being tested?
- Cognitive dual task training (intervention group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Oct 2023to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-40 years old.
- Having suffered an ACL rupture.
- Undergoing a surgical ACL reconstruction in the AZ Delta hospital in Roeselare (Campus Brugsesteenweg).
Who cannot join
- Revision ACL reconstruction.
- Other severe injuries to the lower limbs within the past year.
- Muscle or neurological disorders affecting lower limb functioning.
- Fibromyalgia or chronic fatigue syndrome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
AZ Delta Roeselare (Campus Brugsesteenweg)
Roeselare, West-Vlaanderen, 8800
Thomas Tampere, Dr., 051 23 63 70, sportr@azdelta.be
About this study
Anterior cruciate ligament (ACL) injuries are common in sports and often require a long and challenging rehabilitation process. Athletes who sustain these injuries typically engage in pivoting and cutting sports, where these motor tasks must be performed simultaneously with cognitive tasks such as decision-making and keeping an eye on the opponent. Directing attention to both cognitive and motor tasks leads to cognitive-motor interference, which is associated with movement patterns that increase the risk of ACL (re)injury.
Therefore, it is crucial that before returning to such demanding sports after ACL reconstruction, athletes sufficiently develop and automate safe yet efficient motor skills to free up attentional capacity for decision-making, thereby reducing the risk of suboptimal movement patterns and reinjury.
Read more
However, current rehabilitation programs often primarily focus on the motor component in a single-task manner, giving insufficient attention to the cognitive component that is inseparable from sports.
This randomized controlled trial aims to investigate the effects of implementing motor-cognitive dual tasks in the end phase rehabilitation after ACL reconstruction on muscle function, functional outcomes, and patient-reported outcomes.
- Being tested
- Cognitive dual task training (intervention group), Standard of care physiotherapy (control group)
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive dual task training (intervention group)Other
Simultaneously performing cognitive tasks and motor rehabilitative exercises.
Standard of care physiotherapy (control group)Other
The current best physical therapy treatment for patients with anterior cruciate ligament reconstruction based on existing scientific evidence.
| Study group | Role | What they receive |
|---|---|---|
| Dual task training | Experimental | Patients will recieve 12 sessions (2x/week) of standard of care exercise-based physiotherapy with implementation of cognitive dual task training. This implies that the patients will perform cognitive tasks simultaneously during at least 50% of their physical rehabilitative exercises. Receives: Other: Cognitive dual task training (intervention group) |
| Standard of care physiotherapy | Active comparator | Patients will recieve 12 sessions (2x/week) of standard of care exercise-based physiotherapy without implementation of cognitive dual task training. Receives: Other: Standard of care physiotherapy (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological readiness to return to sport
Questioned using the ACL-RSI. Scores range from 0 to 100. Higher scores indicate higher psychological readiness.
Measured: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Quadriceps and hamstrings activity / cocontraction during hop tasks
Electromyographical measurement of quadriceps and hamstrings activation during hop tasks.
Measured: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Patient reported knee function
Questioned using the Knee Injury and Osteoarthritis Outcome Score (KOOS) with its different subscores. Scores on the KOOS range from 0-100, with 0 representing the greatest possible problems in terms of knee function and 100 representing no problems.
Measured: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Jumping height in hop tests
Performance in single hop tests and a single leg drop-jump expressed by jump height in centimeters.
Measured: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Activity level
Questioned using the Tegner Score. The scores range from 0 to 10, with higher scores indicating higher activity levels.
Measured: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Voluntary quadriceps activation
A force-based isometric biodex measurement using the interpolated twitch/superimposed burst technique.
Measured: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Secondary outcomes (4)
Quadriceps and hamstrings strength
Measured on the biodex.
Measured: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Kinesiophobia
Questioned using the Tampa Scale of Kinesiophobia (TSK). Scores on the TSK range from 17 to 68, with higher scores indicating more kinesiophobia.
Measured: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Subjective knee stability
Questioned using the first question of the Lysholm questionnaire. Scores range from 0 to 25 with 25 indicating no symptoms of subjective instability.
Measured: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
The amount of pain that the subjects experience.
Questioned using a Numeric Rating Scale. The scores range between 0 and 10 with 10 0representing the highest level of pain.
Measured: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start15 Oct 2023
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206200
- Sponsor's protocol ID
- ONZ-2023-0365
- Acronym
- AMIRA
- Status last verified
- Jul 2024
- First submitted
- 2 Jan 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cognitive Dual-Tasking in Later Stages of Rehabilitation After ACL Reconstruction
- ClinicalTrials.gov ID
- NCT06206200
- Acronym / sponsor ID
- AMIRA / ONZ-2023-0365
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 16 Jan 2024 (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.
Anterior cruciate ligament (ACL) injuries are common in sports and often require a long and challenging rehabilitation process. Athletes who sustain these injuries typically engage in pivoting and cutting sports, where these motor tasks must be performed simultaneously with cognitive tasks such as decision-making and keeping an eye on the opponent. Directing attention to both cognitive and motor tasks leads to cognitive-motor interference, which is associated with movement patterns that increase the risk of ACL (re)injury.
Therefore, it is crucial that before returning to such demanding sports after ACL reconstruction, athletes sufficiently develop and automate safe yet efficient motor skills to free up attentional capacity for decision-making, thereby reducing the risk of suboptimal movement patterns and reinjury.
However, current rehabilitation programs often primarily focus on the motor component in a single-task manner, giving insufficient attention to the cognitive component that is inseparable from sports.
This randomized controlled trial aims to investigate the effects of implementing motor-cognitive dual tasks in the end phase rehabilitation after ACL reconstruction on muscle function, functional outcomes, and patient-reported outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual task training | Experimental | Other: Cognitive dual task training (intervention group)Patients will recieve 12 sessions (2x/week) of standard of care exercise-based physiotherapy with implementation of cognitive dual task training. This implies that the patients will perform cognitive tasks simultaneously during at least 50% of their physical rehabilitative exercises. |
| Standard of care physiotherapy | Active comparator | Other: Standard of care physiotherapy (control group)Patients will recieve 12 sessions (2x/week) of standard of care exercise-based physiotherapy without implementation of cognitive dual task training. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-40 years old.
- Having suffered an ACL rupture.
- Undergoing a surgical ACL reconstruction in the AZ Delta hospital in Roeselare (Campus Brugsesteenweg).
Key exclusion criteria (4 listed)
- Revision ACL reconstruction.
- Other severe injuries to the lower limbs within the past year.
- Muscle or neurological disorders affecting lower limb functioning.
- Fibromyalgia or chronic fatigue syndrome.
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 |
|---|---|---|
| Cognitive dual task training (intervention group)Simultaneously performing cognitive tasks and motor rehabilitative exercises. | Other | Dual task training |
| Standard of care physiotherapy (control group)The current best physical therapy treatment for patients with anterior cruciate ligament reconstruction based on existing scientific evidence. | Other | Standard of care physiotherapy |
Primary outcome
Psychological readiness to return to sport
Time frame: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Questioned using the ACL-RSI. Scores range from 0 to 100. Higher scores indicate higher psychological readiness.
Quadriceps and hamstrings activity / cocontraction during hop tasks
Time frame: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Electromyographical measurement of quadriceps and hamstrings activation during hop tasks.
Patient reported knee function
Time frame: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Questioned using the Knee Injury and Osteoarthritis Outcome Score (KOOS) with its different subscores. Scores on the KOOS range from 0-100, with 0 representing the greatest possible problems in terms of knee function and 100 representing no problems.
Jumping height in hop tests
Time frame: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Performance in single hop tests and a single leg drop-jump expressed by jump height in centimeters.
Activity level
Time frame: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Questioned using the Tegner Score. The scores range from 0 to 10, with higher scores indicating higher activity levels.
Voluntary quadriceps activation
Time frame: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
A force-based isometric biodex measurement using the interpolated twitch/superimposed burst technique.
4 secondary outcomes
Quadriceps and hamstrings strength
Time frame: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Kinesiophobia
Time frame: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Subjective knee stability
Time frame: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
The amount of pain that the subjects experience.
Time frame: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive dual task training (intervention group) in people with Anterior Cruciate Ligament Reconstruction and Athrogenic Muscle Responses, run by University Ghent at 1 site in Belgium.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 Jul 2024. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evy Deschaumes, MSc (+32 9 332 5503, evy.deschaumes@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological readiness to return to sport (time frame: 5 months post ACL reconstruction (= prior to intervention); 7 months post ACL reconstruction (= after the intervention); 9 months post ACL reconstruction (= after a 2 month retention period)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2024.