Mechanical Perturbation Training for ACL Injury Prevention

NCT03080402 | Unknown

• 2 other identifiers: R44HD0680545R44HD068054
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective trial will be used to evaluate the efficacy of prophylactic mechanical perturbation training program. 24 female athletes who are regular participants in activities that involve cutting, pivoting, jumping, and lateral movements prior to injury who range in age from 15-30 year are eligible. Using a prospective risk stratification design, female athletes with knee abduction moment (KAM) \> 25.25 Nm from drop jump motion analysis will be classified as high KAM and will receive 12 sessions of mechanically-driven perturbation training and female athletes with KAM \< 25.25 Nm from drop jump motion analysis will be classified as normal KAM and only participate in baseline performance testing, followed 6 weeks later by another session of drop jump motion analysis and performance testing.

Conditions

Anterior Cruciate Ligament Injury; ACL

Keywords

Anterior Cruciate Ligament; ACL injury; Injury prevention; Perturbation training; Risk factors

Outcome Measures

Primary Outcomes (1)

• Peak knee abduction moment

  Peak knee abduction moment during a drop jump landing task as assessed via motion analysis

  baseline and 6 weeks after baseline testing

Secondary Outcomes (8)

• Peak Quadriceps torque 60 degrees/sec

  baseline and 6 weeks after baseline testing

• Peak Quadriceps torque 240 degrees/sec

  baseline and 6 weeks after baseline testing

• Peak Hamstrings torque 60 degrees/sec

  baseline and 6 weeks after baseline testing

• Peak Hamstrings torque 240 degrees/sec

  baseline and 6 weeks after baseline testing

• Single hop for distance LSI

  baseline and 6 weeks after baseline testing

Other Outcomes (1)

• Vertical Jump

  baseline and 6 weeks after baseline testing

Study Arms (2)

High KAM

EXPERIMENTAL

Mechanically-driven neuromuscular training. 2 times per week for 6 weeks for a total of 12 sessions. Perturbation training

Device: Mechanical Perturbation Training

Normal KAM

NO INTERVENTION

No intervention

Interventions

Mechanical Perturbation Training DEVICE

The training program will consist of three stages and subjects will progress through each neuromuscular training stage.The training will consist of double- to single-limb movements with progression of jumping, hopping, and pivoting maneuvers on the perturbation device with an emphasis on proper technique and landing. The initial four sessions will focus on primarily on jumping and hopping maneuvers on double- and single-limb in the sagittal plane. The intermediate four sessions will incorporate additional medial and lateral maneuvers with the plyometric tasks. The final four sessions will incorporate rotational and pivoting activities with the maneuvers. The resultant protocol has been derived and optimized from previous published research studies and prevention techniques.

Also known as: Reactive Agility Platform Trainer 2.0, RAPTr

High KAM

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female athletes will be eligible if they are: 1) regular participants in Level 1 and 2 sports (cutting and pivoting type sports, and 2) ages 15-30 years

You may not qualify if:

• History of major injury or surgery to the legs.

Sponsors & Collaborators

• University of Delaware: lead
• Simbex, LLC: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Delaware, Physical Therapy Department

Newark, Delaware, 19716, United States

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Lynn Snyder-Mackler, PT, ATC, ScD

  University of Delaware

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martha Callahan

CONTACT

(302) 831-6202; mcall@udel.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alumni Distinguished Professor

Model Details: 24 female athletes (12 with high KAM; 12 with normal KAM) will be recruited into the intervention/ testing phase of this study. Female athletes with KAM \> 25.25 Nm will be classified as high KAM and will receive 12 sessions of mechanically-driven perturbation training and female athletes with KAM \< 25.25 Nm will be classified as normal KAM and only participate in baseline performance testing, followed 6 weeks later by another session of drop jump motion analysis and performance testing.

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 15, 2017
• Study Start: February 20, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 15, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)