The Effects of Cognitive Dual-Tasking in Later Stages of Rehabilitation After ACL Reconstruction

NCT06206200 | Recruiting

• 1 other identifier: ONZ-2023-0365
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Anterior Cruciate Ligament Reconstruction; Athrogenic Muscle Responses; ACL Injury

Outcome Measures

Primary Outcomes (6)

• 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)

• Quadriceps and hamstrings activity / cocontraction during hop tasks

  Electromyographical measurement of quadriceps and hamstrings activation during hop 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)

• 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.

  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.

  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)

• 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)

Secondary Outcomes (4)

• Quadriceps and hamstrings strength

  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

  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

  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.

  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 Outcomes (4)

• Duration of ground contact in hop tests

  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

  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

  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)

Study Arms (2)

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.

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.

Other: Standard of care physiotherapy (control group)

Interventions

Cognitive dual task training (intervention group) OTHER

Simultaneously performing cognitive tasks and motor rehabilitative exercises.

Dual task training

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.

Standard of care physiotherapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old.
• Having suffered an ACL rupture.
• Undergoing a surgical ACL reconstruction in the AZ Delta hospital in Roeselare (Campus Brugsesteenweg).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Ghent: lead
• Research Foundation Flanders: collaborator

Study Sites (1)

AZ Delta Roeselare (Campus Brugsesteenweg)

Roeselare, West-Vlaanderen, 8800, Belgium

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Evy Deschaumes, MSc

CONTACT

+32 9 332 5503; evy.deschaumes@ugent.be

Erik Witvrouw, prof. dr.

CONTACT

+32 9 332 26 32; erik.witvrouw@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 16, 2024
• Study Start: October 15, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

BE (1)