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

U

University Ghent

Status

Enrolling

Conditions

Athrogenic Muscle Responses
Arthrogenic Muscle Inhibition
Anterior Cruciate Ligament Reconstruction
ACL Injury

Treatments

Other: Cognitive dual task training (intervention group)
Other: Standard of care physiotherapy (control group)

Study type

Interventional

Funder types

Other

Identifiers

NCT06206200
ONZ-2023-0365

Details and patient eligibility

About

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.

Enrollment

190 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

190 participants in 2 patient groups

Dual task training
Experimental group
Description:
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.
Treatment:
Other: Cognitive dual task training (intervention group)
Standard of care physiotherapy
Active Comparator group
Description:
Patients will recieve 12 sessions (2x/week) of standard of care exercise-based physiotherapy without implementation of cognitive dual task training.
Treatment:
Other: Standard of care physiotherapy (control group)

Trial contacts and locations

1

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Central trial contact

Evy Deschaumes, MSc; Erik Witvrouw, prof. dr.

Data sourced from clinicaltrials.gov

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