SBIR-STTR Award

Dynamic Perturbation Training System for Acl Rehabilitation
Award last edited on: 6/14/17

Sponsored Program
SBIR
Awarding Agency
NIH : NICHD
Total Award Amount
$2,558,398
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
Richard M Greenwald

Company Information

Simbex LLC

10 Water Street Suite 410
Lebanon, NH 03766
   (603) 448-2367
   info@simbex.com
   www.simbex.com
Location: Single
Congr. District: 02
County: Grafton

Phase I

Contract Number: 1R44HD068054-01
Start Date: 4/1/11    Completed: 11/30/11
Phase I year
2011
Phase I Amount
$172,424
Anterior cruciate ligament (ACL) injuries are a significant problem for athletes, and women in particular. Both surgical and non-surgical treatment options exist, with the ultimate goal of regaining joint stability, knee kinematics, and quadriceps strength compared to the uninjured contralateral limb to allow full return of function and activity level and to prevent additional injury to the cartilage and the meniscus in the knee which might lead to an increased likelihood of osteoarthritis (OA). Published research has demonstrated clinically relevant effects of perturbation of support surface training for both ACL-deficient and ACL-reconstructed populations for improving dynamic knee stability, particularly in females. The clinically available methods of delivering the desired perturbations are currently limited to static balance boards that are manually pushed or pulled by the physical therapist. These perturbations may not simulate real-life perturbations that would occur during walking or running. The Principal Objective of this Fast Track SBIR project is to develop and validate a cost-effective commercial product, ActiveStep-Sport", for providing task-specific, neuromuscular, dynamic perturbation training to improve outcomes for both conservative and surgical treatment of ACL injury (ACL), particularly in young athletes and women.

Public Health Relevance:
The proposed ActiveStep-Sport system provides the enabling technology for large-scale application of clinically relevant perturbation of support surface training for anterior cruciate ligament (ACL) injury rehablitiation. Approximately 100,000-175,000 ACL reconstructions performed annually in the US annually, with females significantly more likely to suffer an ACL rupture than males. Perturbation training in certain ACL injured populations has been shown to reduce episodes of giving way and to reduce abnormal knee kinematics, both of which often lead to an inability to regain functional levels of sports participation and increase the potential for developing knee osteoarthritis. Use of perturbation training is hypothesized to improve knee kinematics compared to strengthening alone, and to improve outcomes for ACL rehabilitation. The technology developed here represents a translation of validated laboratory-based research methodology to a system more suited for widespread clinical use. If technically and economically feasible, ActiveStep-Sport will help reduce the overall health care costs associated with the treatment and rehabilitation of ACL injuries and the onset of osteoarthritis.

Thesaurus Terms:
Address;Adopted;Algorithms;Analysis, Cost;Anterior Cruciate Ligament;Arthritis, Degenerative;Articulation;Cartilage;Cartilagenous Tissue;Clinical;Clinical Trials;Clinical Trials, Unspecified;Computer Programs;Computer Software;Contralateral;Cost Analyses;Cost Analysis;Data;Degenerative Polyarthritis;Delaware;Development;Devices;Equilibrium;Equipment;Extremities;Feedback;Female;Funding;Goals;Health Care Costs;Health Costs;Healthcare Costs;Impairment;Individual;Injury;Intervention;Intervention Strategies;Joints;Knee;Knee Osteoarthritis;Laboratories;Lateral;Lead;Life;Limb Structure;Limbs;Manuals;Meniscus;Meniscus Structure Of Joint;Methodology, Research;Methods;Metric;Motion;Nih;National Institutes Of Health;National Institutes Of Health (U.S.);Non-Trunk;Operation;Operative Procedures;Operative Surgical Procedures;Osteoarthritis;Osteoarthrosis;Outcome;Patients;Pb Element;Performance;Phase;Physical Health Services / Rehabilitation;Pilot Projects;Population;Protocol;Protocols Documentation;Publishing;Quadriceps Muscle Of The Thigh;Rehabilitation;Rehabilitation Outcome;Rehabilitation Therapy;Rehabilitation, Medical;Research;Research Methodology;Research Methods;Running;Sbir;Sbirs (R43/44);Simulate;Small Business Innovation Research;Small Business Innovation Research Grant;Software;Sports;Surface;Surgical;Surgical Interventions;Surgical Procedure;System;System, Loinc Axis 4;Technology;Testing;Therapeutic;Time;Training;Translating;Translatings;Translations;United States National Institutes Of Health;Universities;Validation;Walking;Woman;Anterior Cruciate Ligament Reconstruction;Anterior Cruciate Ligament Rupture;Balance;Balance Function;Base;Clinical Applicability;Clinical Application;Clinical Investigation;Clinical Practice;Clinical Relevance;Clinically Relevant;Commercialization;Comparative Effectiveness;Computer Program /Software;Computer Program/Software;Cost Effective;Degenerative Joint Disease;Design;Designing;Heavy Metal Pb;Heavy Metal Lead;Human Subject;Hypertrophic Arthritis;Improved;Injured;Interventional Strategy;Kinematics;Language Translation;Ligament Injury;Male;Man;Man's;Meetings;Model Design;Neuromuscular;Novel;Patient Population;Pilot Study;Prevent;Preventing;Prototype;Rehabilitative;Strength Training;Surgery;University;User-Friendly

Phase II

Contract Number: 4R44HD068054-02
Start Date: 4/1/11    Completed: 2/28/14
Phase II year
2012
(last award dollars: 2017)
Phase II Amount
$2,385,974

Anterior cruciate ligament (ACL) injuries are a significant problem for athletes, and women in particular. Both surgical and non-surgical treatment options exist, with the ultimate goal of regaining joint stability, knee kinematics, and quadriceps strength compared to the uninjured contralateral limb to allow full return of function and activity level and to prevent additional injury to the cartilage and the meniscus in the knee which might lead to an increased likelihood of osteoarthritis (OA). Published research has demonstrated clinically relevant effects of perturbation of support surface training for both ACL-deficient and ACL-reconstructed populations for improving dynamic knee stability, particularly in females. The clinically available methods of delivering the desired perturbations are currently limited to static balance boards that are manually pushed or pulled by the physical therapist. These perturbations may not simulate real-life perturbations that would occur during walking or running. The Principal Objective of this Fast Track SBIR project is to develop and validate a cost-effective commercial product, ActiveStep-Sport", for providing task-specific, neuromuscular, dynamic perturbation training to improve outcomes for both conservative and surgical treatment of ACL injury (ACL), particularly in young athletes and women.

Public Health Relevance Statement:
The proposed ActiveStep-Sport system provides the enabling technology for large-scale application of clinically relevant perturbation of support surface training for anterior cruciate ligament (ACL) injury rehablitiation. Approximately 100,000-175,000 ACL reconstructions performed annually in the US annually, with females significantly more likely to suffer an ACL rupture than males. Perturbation training in certain ACL injured populations has been shown to reduce episodes of giving way and to reduce abnormal knee kinematics, both of which often lead to an inability to regain functional levels of sports participation and increase the potential for developing knee osteoarthritis. Use of perturbation training is hypothesized to improve knee kinematics compared to strengthening alone, and to improve outcomes for ACL rehabilitation. The technology developed here represents a translation of validated laboratory-based research methodology to a system more suited for widespread clinical use. If technically and economically feasible, ActiveStep-Sport will help reduce the overall health care costs associated with the treatment and rehabilitation of ACL injuries and the onset of osteoarthritis.

Project Terms:
Address; Adopted; Algorithms; Anterior Cruciate Ligament; anterior cruciate ligament reconstruction; anterior cruciate ligament rupture; base; Cartilage; Clinical; clinical application; clinical practice; Clinical Trials; clinically relevant; commercialization; comparative effectiveness; Computer software; Contralateral; Cost Analysis; cost effective; Data; Degenerative polyarthritis; Delaware; design; Development; Devices; Equilibrium; Equipment; Feedback; Female; Funding; Goals; Health Care Costs; human subject; Impairment; improved; Individual; injured; Injury; Intervention; Joints; kinematics; Knee; Knee Osteoarthritis; Laboratories; Lateral; Lead; Life; ligament injury; Limb structure; male; man; Manuals; meetings; Meniscus structure of joint; Methods; Metric; model design; Motion; neuromuscular; novel; Operative Surgical Procedures; Outcome; patient population; Patients; Performance; Phase; Pilot Projects; Population; prevent; Protocols documentation; prototype; Publishing; Quadriceps Muscle of the Thigh; Rehabilitation Outcome; Rehabilitation therapy; Research; Research Methodology; Running; Simulate; Small Business Innovation Research Grant; Sports; strength training; Surface; System; Technology; Testing; Therapeutic; Time; Training; Translating; Translations; United States National Institutes of Health; Universities; user-friendly; Validation; Walking; Woman