ACL-injuryNCT02316639
The Effectiveness of Neuromuscular Training in Healthy and ACL-Injured Adolescent Females
A study testing Neuromuscular Training in people with ACL-injury, run by University of Manitoba at 1 site in Canada.
Trial summary
Recently, there has been a dramatic rise in the number of children participating in competitive sports. Adolescents involved in sports that require cutting, pivoting or body contact are at greatest risk for sustaining an anterior cruciate ligament (ACL) rupture of the knee, however, appropriate management remains… Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL-injury
- What is being tested?
- Neuromuscular Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Aug 2016
- 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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages 10-14.
- Radiographic evidence of skeletally immaturity at the knee joint.
- ACL-injured patients require a clinical examination and a KT-1000 test of > 3mm compared with the contralateral knee to confirm a uni-lateral ACL injury diagnosis.
- Pass the standardized screening protocol, which includes:
- No evidence of joint effusion via swipe test ii. Full passive knee joint range of motion iii. Full active knee extension during a straight leg raise test iv. Quadriceps femoris maximum voluntary isometric contraction force on the involved limb equivalent to 75% of that on the uninvolved limb v. Tolerance for 10 consecutive single-leg hops on the involved limb without pain.
Who cannot join
- Symptomatic meniscus or concomitant knee ligament injuries.
- Recent history (within the 6 months) of a traumatic head (concussion), hip, knee or ankle injury.
- Reports more than one episode of the knee giving way or buckling resulting in pain and joint effusion from the time of injury. The mechanism at the time of injury is not included.
- Actively participating in another rehabilitation protocol during the course of the study.
- Unwillingness or inability to return for follow-up test sessions.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Pan Am Clinic
Winnipeg, Manitoba, R3M 3E4
Alison Longo, MSc, 204-927-2829, alongo@panamclinic.com
Jason Peeler, PhD
About this study
Recently, there has been a dramatic rise in the number of children participating in competitive sports. Adolescents involved in sports that require cutting, pivoting or body contact are at greatest risk for sustaining an anterior cruciate ligament (ACL) rupture of the knee, however, appropriate management remains controversial. The surgical technique is commonly performed in the adult population has been associated with risks for growth disturbance when performed on skeletally immature individuals. Therefore, the recommended standard of care in children is to initially follow a non-surgical management protocol that allows a patient to skeletally mature prior to ultimately receiving surgical reconstruction. Unfortunately, current non-surgical management protocols are ineffective at enhancing knee joint stability and dynamic function. There has been no research to indicate the most appropriate exercise program for the ACL deficient skeletally immature individual. A neuromuscular exercise program proven to be safe and effective in the ACL deficient adult population is perturbation training. In adolescents, research suggests neuromuscular exercises can reduce the rate of ACL injuries by 50%. However, currently there is no research investigating the benefits of a neuromuscular exercise on the management of a skeletally immature ACL-deficient individual. The results of this investigation will provide researchers and clinicians valuable information on the effect of neuromuscular perturbation exercises on knee joint stability and function immediately following injury. This has the potential to minimize the development of secondary meniscal tears and premature joint degeneration commonly demonstrated following an ACL injury.
Read the detailed description
Following ethics approval by the University of Manitoba and the Winnipeg Regional Health Authority, 44 participants will be recruited for the study. During the intake session, subjects will complete informed and assent consent, participant information and knee demographic forms. A radiographic report of the knee confirming that the subject is skeletally immature will be obtained from the referring orthopedic surgeon or performed at the Pan Am clinic. For only the ACL-injured subjects, a clinical examination diagnosis and KT-1000 test will confirm the injury. Anthropometric data, such as age, height, weight, range of motion, leg circumference and the pubertal maturation observation scale (PMOS), will be collected. All subjects are required to pass the standardized screening protocol prior to continuing with the testing procedures.
Testing Sessions:
Each subject will participate in 4 follow-up test sessions after the initial intake; Pre-exercise session at the start of the study, Follow-up #1 at the mid-point of the study, Follow-up #2 at the end of the study and a Test-retest session during the no exercise phase of the study. Within the same week as completing the intake session, all subjects will complete the pre-exercise test session. All follow-up testing sessions will include: 1. Subjective evaluation of knee function via the Pedi-IKDC and Physical Activity Questionnaire for Children (PAQ-C), 2. Standardized warm-up on a stationary bike, 3. Dynamic balance evaluation using the SEBT and Y-Balance tests, 4. Strength testing using the Biodex isokinetic dynamometer and core stability tests, and 5. Knee laxity testing using the KT-1000. Both ACL-injured and healthy knee subjects will be randomly divided into two groups, Group A \& B. The week following baseline testing, Group A will begin the 5-week NMT protocol, complete a follow-up #1 testing session, then receive no intervention for 5 weeks, and return for a follow-up #2 testing session. The week following baseline testing, Group B will receive of no intervention for 5 weeks, then complete a follow-up #1 test session, complete the 5-week NMT protocol and then return for a follow-up #2 testing session. The test-retest session will be conducted during the first week of the "No Exercise" phase.
Neuromuscular Training (NMT) Sessions:
The established Neuromuscular Training (NMT) protocol is supervised, progressive program in which the patient maintains balance on three different support surfaces while a clinician administers purposeful manipulations of the support system.1 The patient maintains a single-leg stance on the rollerboard and tiltboard surfaces, and a two-leg stance with one foot on a roller board while the other is on a platform. Participants will complete two training sessions per week, for five weeks for a total of 10 training sessions. During each session, both legs will receive training for 2-3 sets of 1 minute duration on each of the support surfaces. Subjects will complete all training sessions with a Certified Athletic Therapist or Physiotherapist at the Pan Am clinic.
- Conditions
- ACL-injury
- Being tested
- Neuromuscular Training
- Keywords
- Neuromuscular Training, Skeletally Immature, Knee Rehabilitation
- 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.
Neuromuscular TrainingOther
The established Neuromuscular Training (NMT) protocol is supervised, progressive program in which the patient maintains balance on three different support surfaces while a clinician administers purposeful manipulations of the support system.1 The patient maintains a single-leg stance on the rollerboard and tiltboard surfaces, and a two-leg stance with one foot on a roller board while the other is on a platform. Participants will complete two training sessions per week, for five weeks for a total of 10 training sessions.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular Training - No Exercise | Experimental | Subjects will participate in 5 weeks of neuromuscular training followed by 5 weeks of no exercise intervention Receives: Other: Neuromuscular Training |
| No Exercise - Neuromuscular Training | Experimental | No exercises will be administered for 5 weeks, followed by 5 weeks of neuromuscular Training. Receives: Other: Neuromuscular Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Star Excursion Balance Test (SEBT) at week 7
The SEBT is a valid and reliable non-instrumented test to evaluate dynamic balance in healthy and ACL-injured subjects, however use in the skeletally immature population is lacking in the literature. The subjects perform a series of single-limb squats using the non-stance limb to reach maximally to touch a point along 1 of 8 designated lines on the ground. The reach distance is normalized to the subject's leg length to allow comparison of performance between limbs (injured vs non-injured), between subjects (healthy vs ACL-injured) and before \& after an intervention to quantify deficits or improvements in dynamic postural-control. Subjects will perform 4 familiarization trials in each direction, as indicated by previous research. Both limbs will be tested in each direction with the average of the 3 test trails being used for data analysis.
Measured: week 7
Secondary outcomes (3)
Change from baseline in Y-Balance Test at week 7
The Y-balance test is a commercially available product that evaluates three components of the SEBT. The instrumented version was designed to improve the efficiency of the SEBT. Subjects maintain a one-leg stance on an elevated stance platform from which 3 pieces of plastic pipe extend in the anterior, posteromedial and posterolateral reach directions. With the non-stance foot participants push an indicator to a maximum distance along the pipe, which is marked with 5mm increments. Research indicates that the test is a feasible and reproducible measure of dynamic postural control in children, as well as adults, however testing within the ACL-injured population is lacking. Following the standardized testing procedures, 6 familiarization trials will be performed prior to collecting data for the test trials. The average maximal reach distance for each direction will be used for data analysis.
Measured: week 7
Change from baseline in Y-Balance Test at week 13
The Y-balance test is a commercially available product that evaluates three components of the SEBT. The instrumented version was designed to improve the efficiency of the SEBT. Subjects maintain a one-leg stance on an elevated stance platform from which 3 pieces of plastic pipe extend in the anterior, posteromedial and posterolateral reach directions. With the non-stance foot participants push an indicator to a maximum distance along the pipe, which is marked with 5mm increments. Research indicates that the test is a feasible and reproducible measure of dynamic postural control in children, as well as adults, however testing within the ACL-injured population is lacking. Following the standardized testing procedures, 6 familiarization trials will be performed prior to collecting data for the test trials. The average maximal reach distance for each direction will be used for data analysis.
Measured: week13
Change from baseline in Star Excursion Balance Test at week 13
The SEBT is a valid and reliable non-instrumented test to evaluate dynamic balance in healthy and ACL-injured subjects, however use in the skeletally immature population is lacking in the literature. The subjects perform a series of single-limb squats using the non-stance limb to reach maximally to touch a point along 1 of 8 designated lines on the ground. The reach distance is normalized to the subject's leg length to allow comparison of performance between limbs (injured vs non-injured), between subjects (healthy vs ACL-injured) and before \& after an intervention to quantify deficits or improvements in dynamic postural-control. Subjects will perform 4 familiarization trials in each direction, as indicated by previous research. Both limbs will be tested in each direction with the average of the 3 test trails being used for data analysis.
Measured: week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
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.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jason Peeler, University of Manitoba
- Investigators
- Jason Peeler, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316639
- Sponsor's protocol ID
- H2014:302
- Status last verified
- Aug 2015
- First submitted
- 16 Sep 2014
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Neuromuscular Training in Healthy and ACL-Injured Adolescent Females
- ClinicalTrials.gov ID
- NCT02316639
- Acronym / sponsor ID
- H2014:302
- Conditions
- ACL-injury
- Keywords
- Neuromuscular Training, Skeletally Immature, Knee Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 15 Dec 2014 (estimated)
- 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.
Recently, there has been a dramatic rise in the number of children participating in competitive sports. Adolescents involved in sports that require cutting, pivoting or body contact are at greatest risk for sustaining an anterior cruciate ligament (ACL) rupture of the knee, however, appropriate management remains controversial. The surgical technique is commonly performed in the adult population has been associated with risks for growth disturbance when performed on skeletally immature individuals. Therefore, the recommended standard of care in children is to initially follow a non-surgical management protocol that allows a patient to skeletally mature prior to ultimately receiving surgical reconstruction. Unfortunately, current non-surgical management protocols are ineffective at enhancing knee joint stability and dynamic function. There has been no research to indicate the most appropriate exercise program for the ACL deficient skeletally immature individual. A neuromuscular exercise program proven to be safe and effective in the ACL deficient adult population is perturbation training. In adolescents, research suggests neuromuscular exercises can reduce the rate of ACL injuries by 50%. However, currently there is no research investigating the benefits of a neuromuscular exercise on the management of a skeletally immature ACL-deficient individual. The results of this investigation will provide researchers and clinicians valuable information on the effect of neuromuscular perturbation exercises on knee joint stability and function immediately following injury. This has the potential to minimize the development of secondary meniscal tears and premature joint degeneration commonly demonstrated following an ACL injury.
Detailed description
Following ethics approval by the University of Manitoba and the Winnipeg Regional Health Authority, 44 participants will be recruited for the study. During the intake session, subjects will complete informed and assent consent, participant information and knee demographic forms. A radiographic report of the knee confirming that the subject is skeletally immature will be obtained from the referring orthopedic surgeon or performed at the Pan Am clinic. For only the ACL-injured subjects, a clinical examination diagnosis and KT-1000 test will confirm the injury. Anthropometric data, such as age, height, weight, range of motion, leg circumference and the pubertal maturation observation scale (PMOS), will be collected. All subjects are required to pass the standardized screening protocol prior to continuing with the testing procedures.
Testing Sessions:
Each subject will participate in 4 follow-up test sessions after the initial intake; Pre-exercise session at the start of the study, Follow-up #1 at the mid-point of the study, Follow-up #2 at the end of the study and a Test-retest session during the no exercise phase of the study. Within the same week as completing the intake session, all subjects will complete the pre-exercise test session. All follow-up testing sessions will include: 1. Subjective evaluation of knee function via the Pedi-IKDC and Physical Activity Questionnaire for Children (PAQ-C), 2. Standardized warm-up on a stationary bike, 3. Dynamic balance evaluation using the SEBT and Y-Balance tests, 4. Strength testing using the Biodex isokinetic dynamometer and core stability tests, and 5. Knee laxity testing using the KT-1000. Both ACL-injured and healthy knee subjects will be randomly divided into two groups, Group A \& B. The week following baseline testing, Group A will begin the 5-week NMT protocol, complete a follow-up #1 testing session, then receive no intervention for 5 weeks, and return for a follow-up #2 testing session. The week following baseline testing, Group B will receive of no intervention for 5 weeks, then complete a follow-up #1 test session, complete the 5-week NMT protocol and then return for a follow-up #2 testing session. The test-retest session will be conducted during the first week of the "No Exercise" phase.
Neuromuscular Training (NMT) Sessions:
The established Neuromuscular Training (NMT) protocol is supervised, progressive program in which the patient maintains balance on three different support surfaces while a clinician administers purposeful manipulations of the support system.1 The patient maintains a single-leg stance on the rollerboard and tiltboard surfaces, and a two-leg stance with one foot on a roller board while the other is on a platform. Participants will complete two training sessions per week, for five weeks for a total of 10 training sessions. During each session, both legs will receive training for 2-3 sets of 1 minute duration on each of the support surfaces. Subjects will complete all training sessions with a Certified Athletic Therapist or Physiotherapist at the Pan Am clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Training - No Exercise | Experimental | Other: Neuromuscular TrainingSubjects will participate in 5 weeks of neuromuscular training followed by 5 weeks of no exercise intervention |
| No Exercise - Neuromuscular Training | Experimental | Other: Neuromuscular TrainingNo exercises will be administered for 5 weeks, followed by 5 weeks of neuromuscular Training. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Ages 10-14.
- Radiographic evidence of skeletally immaturity at the knee joint.
- ACL-injured patients require a clinical examination and a KT-1000 test of > 3mm compared with the contralateral knee to confirm a uni-lateral ACL injury diagnosis.
- Pass the standardized screening protocol, which includes:
Key exclusion criteria (5 listed)
- Symptomatic meniscus or concomitant knee ligament injuries.
- Recent history (within the 6 months) of a traumatic head (concussion), hip, knee or ankle injury.
- Reports more than one episode of the knee giving way or buckling resulting in pain and joint effusion from the time of injury. The mechanism at the time of injury is not included.
- Actively participating in another rehabilitation protocol during the course of the study.
- Unwillingness or inability to return for follow-up test sessions.
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 |
|---|---|---|
| Neuromuscular TrainingThe established Neuromuscular Training (NMT) protocol is supervised, progressive program in which the patient maintains balance on three different support surfaces while a clinician administers purposeful manipulations of the support system.1 The patient maintains a single-leg stance on the rollerboard and tiltboard surfaces, and a two-leg stance with one foot on a roller board while the other is on a platform. Participants will complete two training sessions per week, for five weeks for a total of 10 training sessions. | Other | Neuromuscular Training - No Exercise, No Exercise - Neuromuscular Training |
Primary outcome
Change from baseline in Star Excursion Balance Test (SEBT) at week 7
Time frame: week 7
The SEBT is a valid and reliable non-instrumented test to evaluate dynamic balance in healthy and ACL-injured subjects, however use in the skeletally immature population is lacking in the literature. The subjects perform a series of single-limb squats using the non-stance limb to reach maximally to touch a point along 1 of 8 designated lines on the ground. The reach distance is normalized to the subject's leg length to allow comparison of performance between limbs (injured vs non-injured), between subjects (healthy vs ACL-injured) and before \& after an intervention to quantify deficits or improvements in dynamic postural-control. Subjects will perform 4 familiarization trials in each direction, as indicated by previous research. Both limbs will be tested in each direction with the average of the 3 test trails being used for data analysis.
3 secondary outcomes
Change from baseline in Y-Balance Test at week 7
Time frame: week 7
Change from baseline in Y-Balance Test at week 13
Time frame: week13
Change from baseline in Star Excursion Balance Test at week 13
Time frame: week 13
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
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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.
Jason Peeler, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Training in people with ACL-injury, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 14 Aug 2015. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason Peeler, PhD (204-272-3146, peelerj@cc.unmanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Star Excursion Balance Test (SEBT) at week 7 (time frame: week 7). 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 14 Aug 2015.