ACL InjuryNCT03654495
Neuroplasticity Associated With Anterior Cruciate Ligament Injury
A study testing Exergame training in people with ACL Injury, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Injury
- What is being tested?
- Exergame training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
The inclusion criteria for the cross-sectional study part are:
- 18- 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.
The exclusion criteria for the cross-sectional study part are:
- 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/].
The inclusion criteria for the longitudinal study part are:
- 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.
The exclusion criteria for the longitudinal study part are:
- 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/].
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuroplasticity Associated With Anterior Cruciate Ligament Injury: A Single Centre, Cross-sectional Observational & Usual-care-controlled Pilot-RCT Assessing a Motor Learning Based Therapy Intervention
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.
Read the detailed description
Whereas three percent of amateur athletes injure their anterior cruciate ligament (ACL) each year, this percentage can be as high as 15% in elite athletes. Because the ACL contains mechanoreceptors it directly influences the neuromuscular control of the knee. ACL deficiency leads to partial deafferentiation which, in turn, alters spinal and supraspinal motor control.
Return to sports following ACL injuries is mostly decided based on time since surgery; however, this decision process produces unsuccessful outcomes; e.g. high re-injury rates or athletes not being able to return to their pre-injury sport levels. The rate of return to preinjury play levels for non-professional pivoting athletes for example is 65%. A recent evidence-based clinical update revealed that it is currently unclear whether there is a benefit of supervised physical therapy rehabilitation compared to home-based rehabilitation or no rehabilitation at all, and comparisons between 19-week with 32-week rehabilitation programmes show no differences in terms of laxity, range of motion, knee function, or measures of leg muscle strength. Evidence-based guidelines suggest practitioners should generally follow a moderate recommendation, which means that the benefits of treatment exceed the potential harm; however, the quality/applicability of the supporting evidence is not as strong. Many rehabilitation programs currently target biomechanical factors; e.g. muscle strength, balance and plyometric function, and consider to a rather lesser extend cognitive or neurological components.
Brain activation for knee flexion/extension motion alters following ACL reconstruction. The brain activation profile following ACL reconstruction may indicate a shift toward a visual-motor strategy as opposed to a sensory-motor strategy to engage in knee movement. This recent research evidence suggests that rehabilitation protocols for ACL reconstruction should additionally be considering neurocognition and its role in movement, neuromuscular control, and injury risk to help improve intervention effectiveness.
However, there is a lack of evidence concerning the feasibility of implementing neurocognitive exercise interventions in a primary rehabilitation program aimed at restoring function following ACL injury. New treatments usually have to go through a series of phases to test whether they are safe and effective before larger scale studies and application in clinical practice are to be considered. The aim of this pilot study was to perform a phase II trial according the model for complex interventions advocated by the British Medical Research Council to test the feasibility and effects of a conventional ACL injury rehabilitation program with added neurocognitive training in a group of ACL injured individuals. This study aims to: (1) compare ACL injured individuals with non-injured individuals, (2) develop an exercise intervention based on research literature theory and to deliver it to ACL injured individuals, (3) evaluate the feasibility of the intervention and the ability to recruit and retain ACL injured individuals, and (4) assess whether the treatment has some effect on neural drive and physical performance.
- Conditions
- ACL Injury
- Being tested
- Exergame training, Usual Care Training
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergame trainingOther
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.
Usual Care TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exergame training; Other: Usual Care Training |
| Usual Care Training | Active comparator | Routine (standard) therapy given based on conventional current-best-evidence Rehabilitation. Receives: Other: Usual Care Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six weeks
Secondary outcomes (4)
Cortico-muscular coherence (CMC); neuronal communication between Motor cortical areas and muscles
CMC is essentially a measure giving an output value ranging from 0 to 1, the higher the number the better is the neuronal communication between motor cortical areas and muscles. Additionally, we will calculate when the coherence estimates will be significantly larger than zero at a specific labda exceeding a confidence limit (CL) with probability of 95% (α=0.05), with the following equation (2), where alpha denotes the significance Level.
Measured: Immediately post-intervention following six weeks of intervention.
gait kinematics; spatio-temporal Parameters of gait
gait kinematics measured with the Physilog® (Gait up Sàrl, Lausanne, Switzerland) via wearable movement sensors (50×37×9.2mm, 19gramms, anatomical curved shape) containing inertial sensors.
Measured: Immediately post-intervention following six weeks of intervention.
Tegner Activity Score (TAS)
Graduated list of activities of daily living, recreation, and competitive sports. Patient selects the level of participation that best describes their current level of activity. A score of 10 is assigned based on the level of activity that the patient selects. Score 0 represents "sick leave or disability pension because of knee problems," a score of 10 corresponds to participation in national and international elite competitive sports. Has been used more recently as a patient-completed questionnaire. A score of 10 is assigned based on the level of activity that the patient selects as best representing their current activity level. Possible score range: 0-10. Higher scores represent participation in higher-level activities.
Measured: Immediately post-intervention following six weeks of intervention.
International Knee Documentation Committee (IKDC) outcome
a knee-specific patient-reported outcome measure
Measured: Immediately post-intervention following six weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial is a two-arm, parallel-group, randomized-controlled pilot trial with a cross-sectional comparison at baseline.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eling DeBruin, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654495
- Sponsor's protocol ID
- BASEC-Nr. 2017-01925
- Other IDs
- ACL-ETH-2017
- Status last verified
- Apr 2019
- First submitted
- 17 Jul 2018
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only anonymised data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplasticity Associated With Anterior Cruciate Ligament Injury: A Single Centre, Cross-sectional Observational & Usual-care-controlled Pilot-RCT Assessing a Motor Learning Based Therapy Intervention
- ClinicalTrials.gov ID
- NCT03654495
- Acronym / sponsor ID
- BASEC-Nr. 2017-01925
- Conditions
- ACL Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Whereas three percent of amateur athletes injure their anterior cruciate ligament (ACL) each year, this percentage can be as high as 15% in elite athletes. Because the ACL contains mechanoreceptors it directly influences the neuromuscular control of the knee. ACL deficiency leads to partial deafferentiation which, in turn, alters spinal and supraspinal motor control.
Return to sports following ACL injuries is mostly decided based on time since surgery; however, this decision process produces unsuccessful outcomes; e.g. high re-injury rates or athletes not being able to return to their pre-injury sport levels. The rate of return to preinjury play levels for non-professional pivoting athletes for example is 65%. A recent evidence-based clinical update revealed that it is currently unclear whether there is a benefit of supervised physical therapy rehabilitation compared to home-based rehabilitation or no rehabilitation at all, and comparisons between 19-week with 32-week rehabilitation programmes show no differences in terms of laxity, range of motion, knee function, or measures of leg muscle strength. Evidence-based guidelines suggest practitioners should generally follow a moderate recommendation, which means that the benefits of treatment exceed the potential harm; however, the quality/applicability of the supporting evidence is not as strong. Many rehabilitation programs currently target biomechanical factors; e.g. muscle strength, balance and plyometric function, and consider to a rather lesser extend cognitive or neurological components.
Brain activation for knee flexion/extension motion alters following ACL reconstruction. The brain activation profile following ACL reconstruction may indicate a shift toward a visual-motor strategy as opposed to a sensory-motor strategy to engage in knee movement. This recent research evidence suggests that rehabilitation protocols for ACL reconstruction should additionally be considering neurocognition and its role in movement, neuromuscular control, and injury risk to help improve intervention effectiveness.
However, there is a lack of evidence concerning the feasibility of implementing neurocognitive exercise interventions in a primary rehabilitation program aimed at restoring function following ACL injury. New treatments usually have to go through a series of phases to test whether they are safe and effective before larger scale studies and application in clinical practice are to be considered. The aim of this pilot study was to perform a phase II trial according the model for complex interventions advocated by the British Medical Research Council to test the feasibility and effects of a conventional ACL injury rehabilitation program with added neurocognitive training in a group of ACL injured individuals. This study aims to: (1) compare ACL injured individuals with non-injured individuals, (2) develop an exercise intervention based on research literature theory and to deliver it to ACL injured individuals, (3) evaluate the feasibility of the intervention and the ability to recruit and retain ACL injured individuals, and (4) assess whether the treatment has some effect on neural drive and physical performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This trial is a two-arm, parallel-group, randomized-controlled pilot trial with a cross-sectional comparison at baseline.
| Arm | Type | Receives |
|---|---|---|
| Exergame Training | Experimental | Other: Exergame training, Other: Usual Care TrainingRoutine (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. |
| Usual Care Training | Active comparator | Other: Usual Care TrainingRoutine (standard) therapy given based on conventional current-best-evidence Rehabilitation. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exergame trainingTraining 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. | Other | Exergame Training |
| Usual Care TrainingRoutine (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. | Other | Exergame Training, Usual Care Training |
Primary outcome
Attrition; number of participants lost at follow-up
Time frame: six weeks
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.
4 secondary outcomes
Cortico-muscular coherence (CMC); neuronal communication between Motor cortical areas and muscles
Time frame: Immediately post-intervention following six weeks of intervention.
gait kinematics; spatio-temporal Parameters of gait
Time frame: Immediately post-intervention following six weeks of intervention.
Tegner Activity Score (TAS)
Time frame: Immediately post-intervention following six weeks of intervention.
International Knee Documentation Committee (IKDC) outcome
Time frame: Immediately post-intervention following six weeks of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No. Only anonymised data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame training in people with ACL Injury, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attrition; number of participants lost at follow-up (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.