Neuroplasticity Associated With Anterior Cruciate Ligament Injury

NCT03654495 | Completed

• 2 other identifiers: BASEC-Nr. 2017-01925ACL-ETH-2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Activation of the brain for knee movement changes after anterior cruciate ligament (ACL) reconstruction. The brain activation profile after ACL reconstruction indicates a shift to a visual-motor control strategy, as opposed to a sensory-motor control strategy to control the knee movement. Recent research suggests that ACL reconstruction rehabilitation protocols should also consider neurocognition and its role in exercise, neuromuscular control, and injury risk to improve the effectiveness of the intervention. However, there is currently no evidence of the feasibility of neurocognitive exercise in a primary rehabilitation program that aims to restore movement function after ACL damage. The purpose of this study is to assess whether conventional ACL injury training with additional cognitive training based on virtual reality is as effective as the sole conventional ACL injury training in participants with ACL injuries.

Conditions

ACL Injury

Outcome Measures

Primary Outcomes (1)

• Attrition; number of participants lost at follow-up

  For recruitment, data for the total sampling frame (both those approached and not approached) for inclusion in the trial is taken to assess generalizability to ACL individuals. This will be assessed at the end of the 6 weeks training period. We measure the inclusion rate-i.e. the proportion of participants invited to participate who enroll into the study-and distinguish between those who refuse, did not respond or who were willing but excluded (volunteered but did not meet the study inclusion criteria). For attrition, we measure the number of participants lost at follow-up. For adherence to the intervention, we record engagement with the intervention, e.g. compliance with all trainings. There are 18 Virtual Reality video game training sessions possible for each individual.

  six weeks

Secondary Outcomes (4)

• Cortico-muscular coherence (CMC); neuronal communication between Motor cortical areas and muscles

  Immediately post-intervention following six weeks of intervention.

• gait kinematics; spatio-temporal Parameters of gait

  Immediately post-intervention following six weeks of intervention.

• Tegner Activity Score (TAS)

  Immediately post-intervention following six weeks of intervention.

• International Knee Documentation Committee (IKDC) outcome

  Immediately post-intervention following six weeks of intervention.

Study Arms (2)

Exergame Training

EXPERIMENTAL

Routine (standard) therapy given based on conventional current-best-evidence Rehabilitation. In addition training on Medical Device (MD): Dividat Senso, DIV-SENSO-H, Dividat GmbH, Software development: ISO 62304:2016; designed to train different aspects of executive functions (EFs; divided attention, working memory, inhibition, and shifting) and physical functions through Virtual Reality video game training.

Other: Exergame training; Other: Usual Care Training

Usual Care Training

ACTIVE COMPARATOR

Routine (standard) therapy given based on conventional current-best-evidence Rehabilitation.

Other: Usual Care Training

Interventions

Exergame training OTHER

Training on Medical Device (MD): Dividat Senso, DIV-SENSO-H, Dividat GmbH, Software development: ISO 62304:2016; designed to train aspects of executive functions (EFs; divided attention, working memory, inhibition, and shifting) and physical functions through Virtual Reality video game training. FITT training principles are implemented; Frequency: three times per week, Intensity: individually adapted VG (allowing training progression), Type: combination of cognitive and motor training, and Time: 20 min training sessions. Training lasts 6 weeks (18 training sessions). Participants train 20 min, three times per week. Training includes one session of each VG (4 min) in a pre-defined order and short breaks (\~1 min) for game change.

Exergame Training

Usual Care Training OTHER

Routine (standard) therapy given based on conventional current-best-evidence Rehabilitation. Preoperative Phase: Diminish inflammation, swelling, and pain; Restore normal range of motion (especially knee extension); Restore voluntary muscle activation Immediate Postoperative Phase (Day 1-7): Restore full passive knee extension; Diminish joint swelling and pain; Restore independent ambulation Early Rehabilitation Phase (Week 2-4): Maintain full passive knee extension; Gradually increase knee flexion; Muscle training Controlled Ambulation Phase (Week 4-10): Restore full knee ROM; Improve lower extremity strength; Enhance proprioception, balance, and neuromuscular control Advanced Activity Phase (Week 10-16): Normalize lower extremity strength; Enhance muscular power and endurance; Improve neuromuscular control; Perform selected sport-specific drills.

Exergame Training; Usual Care Training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 55-year-old subjects
• healthy or in the subacute phase (from 7 to 21 days) or in the chronic phase (≥ one year) after unilateral surgical reconstruction of complete ACL rupture, confirmed by MRI in the medical record and by the surgical procedure.

You may not qualify if:

• not healthy
• bilaterally previous diagnoses in the medical record, such as neuropathic pain in the lower limb, lumbosacral radiculopathy, saphenous nerve entrapment, meralgia paresthetica, fractures, rheumatoid or systemic conditions, other surgeries, post-surgery complications (i.e., thrombosis or osteomyelitis), belonephobia, legs length difference in the lower limb (\>0.5 cm) \[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5413255/\].
• 18- to 55-year-old subjects, in the subacute phase (from 7 to 21 days) after unilateral surgical reconstruction of complete ACL rupture, confirmed by MRI in the medical record and by the surgical procedure.
• bilaterally previous diagnoses in the medical record, such as neuropathic pain in the lower limb, lumbosacral radiculopathy, saphenous nerve entrapment, meralgia paresthetica, fractures, rheumatoid or systemic conditions, other surgeries, post-surgery complications (i.e., thrombosis or osteomyelitis), belonephobia, legs length difference in the lower limb (\>0.5 cm) \[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5413255/\].

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

ETH Hönggerberg

Zurich, 8093, Switzerland

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The aim is to focus on recruitment, attrition and adherence to the rehabilitation intervention. This trial is composed of a comparative cross-sectional part and a randomized conventional rehabilitation-controlled trial part with 1:1 allocation ratio.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This trial is a two-arm, parallel-group, randomized-controlled pilot trial with a cross-sectional comparison at baseline.

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 31, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)