The Effect of Cognitive Dual-task Rehabilitation on Arthrogenic Muscle Responses After ACL Reconstruction

ACL Injury Clinical Trial

— AMIRA  

Official title:

The Effect of Cognitive Dual-task Rehabilitation on Arthrogenic Muscle Responses After Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206200
• Other study ID #: ONZ-2023-0365
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: July 1, 2026

Study information

• Verified date: January 2024
• Source: University Ghent
• Contact: Evy Deschaumes, MSc
• Phone: +32 9 332 5503
• Email: evy.deschaumes[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

After anterior cruciate ligament reconstruction, altered muscle responses around the knee joint are seen, known as arthrogenic muscle responses (AMR). Despite their initially protective function, prolonged presence of these AMR may potentially lead to knee joint pathomechanics, which in turn could contribute to an increased risk of early knee osteoarthritis.

In this trial, the treatment effect of standard physiotherapy on long-term AMR will be compared to the effects of physiotherapy incorporating cognitive dual-task training. Based on earlier strong indications of supraspinal physiopathological mechanisms for AMR, our hypothesis is that exercise therapy combined with cognitive dual-task training will lead to a more natural and less anxious muscle control, thereby reducing AMR.

The presence of AMR will be evaluated 5 months post-operatively in ACL reconstructed patients. Patients who display AMR will be included in this randomized controlled trial. These individuals will be randomly assigned to one of the two treatment strategies and will undergo the respective therapy for six weeks (twice a week). Afterwards, the same test procedure conducted five months after the operation will be repeated two more times to assess the evolution of the AMR: at seven months post-operation to assess the training effect and at nine months post-operation to evaluate the retention of this effect.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 18-40 years old.

• Having suffered an ACL rupture.

• Undergoing a surgical ACL reconstruction in the AZ Delta hospital in Roeselare (Campus Brugsesteenweg).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Reconstruction

Intervention

Other:
• Cognitive dual task training (intervention group)
Simultaneously performing cognitive tasks and motor rehabilitative exercises.
• Standard of care physiotherapy (control group)
The current best physical therapy treatment for patients with anterior cruciate ligament reconstruction based on existing scientific evidence.

Locations

Country	Name	City	State
Belgium	AZ Delta Roeselare (Campus Brugsesteenweg)	Roeselare	West-Vlaanderen

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Jumping height in hop tests	Performance in single hop tests and a single leg drop-jump expressed by jump height in centimeters.	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)
Other	Duration of ground contact in hop tests	Performance in single hop tests and a single leg drop-jump expressed by the duration of ground contact.	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)
Other	Performance in the T-agility test	It will be measured how much time subjects require to complete a T-agility test.	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)
Other	Strength endurance during timed single leg step down and timed single leg squat	The strength endurance of the subjects will be evaluated by the amount of repetitions they can perform in a time span of 30 seconds.	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)
Primary	Voluntary quadriceps activation	A force-based isometric biodex measurement using the interpolated twitch/superimposed burst technique.	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)
Primary	Quadriceps and hamstrings activity / cocontraction during physical tasks	Electromyographical measurement of quadriceps and hamstrings activation during physical tasks.	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	Quadriceps and hamstrings strength	Measured on the biodex.	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	Kinesiophobia	Questioned using the Tampa Scale of Kinesiophobia (TSK). Scores on the TSK range from 17 to 68, with higher scores indicating more kinesiophobia.	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	Patient reported knee function	Questioned using the Knee Injury and Osteoarthritis Outcome Score (KOOS). 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.	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	Psychological readiness to return to sport	Questioned using the ACL-RSI. Scores range from 0 to 100. Higher scores indicate higher psychological readiness.	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	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.	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	Activity level	Questioned using the Tegner Score. The scores range from 0 to 10, with higher scores indicating higher activity levels.	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	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.	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	Expectations regarding return to sport	Questioned using the Tegner Score: 'how active do you want to be at the end of your rehabilitation?'. The scores range from 0 to 10, with higher scores indicating higher activity levels.	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)