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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Reconstruction; ACL Injury; Athrogenic Muscle Responses; Arthrogenic Muscle Inhibition
• Intervention / Treatment: Other: Cognitive dual task training (intervention group); Other: Standard of care physiotherapy (control group)

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evy Deschaumes, MSc; Phone Number: +32 9 332 5503; Email: evy.deschaumes@ugent.be
• Study Contact Backup: Name: Erik Witvrouw, prof. dr.; Phone Number: +32 9 332 26 32; Email: erik.witvrouw@ugent.be

Study Locations

• Belgium
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • Recruiting
      • AZ Delta Roeselare (Campus Brugsesteenweg)
      • Contact: Thomas Tampere, Dr.; Phone Number: 051 23 63 70; Email: sportr@azdelta.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dual task training; 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.	Other: Cognitive dual task training (intervention group); Simultaneously performing cognitive tasks and motor rehabilitative exercises.
Active Comparator: Standard of care physiotherapy; Patients will recieve 12 sessions (2x/week) of standard of care exercise-based physiotherapy without implementation of cognitive dual task training.	Other: Standard of care physiotherapy (control group); The current best physical therapy treatment for patients with anterior cruciate ligament reconstruction based on existing scientific evidence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: Research Foundation Flanders

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Estimated): January 15, 2024

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: ONZ-2023-0365

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No