The Effectiveness of Neuromuscular Training in Healthy and ACL-Injured Adolescent Females

NCT02316639 | Unknown

• 1 other identifier: H2014:302
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

ACL-injury

Keywords

Neuromuscular Training; Skeletally Immature; Knee Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  week 7

Secondary Outcomes (3)

• Change from baseline in Y-Balance Test at week 7

  week 7

• Change from baseline in Y-Balance Test at week 13

  week13

• Change from baseline in Star Excursion Balance Test at week 13

  week 13

Other Outcomes (4)

• Change from baseline in Quadriceps and Hamstring Strength at week 7

  week 7

• Change from baseline in Quadriceps and Hamstring Strength at week 13

  week 13

• Change from baseline in Pedi- International Knee Documentation Committee (IKDC) score at week 7

  week 7

Study Arms (2)

Neuromuscular Training - No Exercise

EXPERIMENTAL

Subjects will participate in 5 weeks of neuromuscular training followed by 5 weeks of no exercise intervention

Other: Neuromuscular Training

No Exercise - Neuromuscular Training

EXPERIMENTAL

No exercises will be administered for 5 weeks, followed by 5 weeks of neuromuscular Training.

Other: Neuromuscular Training

Interventions

Neuromuscular Training OTHER

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.

Neuromuscular Training - No Exercise; No Exercise - Neuromuscular Training

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• i. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Jason Peeler, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Peeler, PhD

CONTACT

204-272-3146; peelerj@cc.unmanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: December 15, 2014
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 14, 2015

Record last verified: 2015-08

Locations

CA (1)