SBIR/STTR Research Award

Behavioral Multimedia for ACL Reconstructive Surgery

Award identifier 7e902e10874bd36ddaae80085490df69343509c2c00464998892eec761c9dd15Awarding agency Department of Health and Human Services · National Institutes of Health

Award amount

$616,216

Program and phase

SBIR · Phase II

Award year

2006

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Award details

Awarding agency
Department of Health and Human Services
Branch
National Institutes of Health
Recipient company
VIRTUAL BRANDS
Proposal award date
Not reported
Contract end date
Not reported
UEI
Not reported
Solicitation number
PHS2006-2
Topic code
Not reported

Research abstract

DESCRIPTION (provided by applicant): Approximately 80,000 Americans sustain acute tears of the anterior cruciate ligament (ACL) of the knee each year, with associated healthcare costs estimated at roughly 1 billion dollars annually. Surgical reconstruction followed by an extended rehabilitation period is commonly recommended for ACL tears. The purpose of this STTR project is to develop a comprehensive behavioral multimedia package designed to reduce preoperative anxiety, decrease pain and anxiety during rehabilitation, and enhance rehabilitation outcome. In a novel application of existing technology, a prototype of an interactive CD-ROM has been developed to provide ACL reconstruction patients with information on surgery- and rehabilitation-related matters and instruction in presurgical and postsurgical coping strategies. Prototype audio recordings based on an empirically validated relaxation and guided imagery protocol for postsurgical ACL rehabilitation have also been produced. Phase II tasks will include: (a) producing final prototypes of the CD-ROM and series of audio recordings (taking into account the results of Phase I studies); and (b) conducting a randomized controlled clinical trial to evaluate the effects of the CD-ROM and audiotape series on presurgical and postsurgical process and outcome variables. In the clinical trial, 132 patients scheduled for ACL reconstruction surgery will be administered measures of demographic and injury-related variables, pain, mood, range-of-motion, knee laxity, and subjective knee symptoms prior to being assigned randomly to an experimental condition or a control condition. Experimental group participants will be exposed to the CD-ROM and series of audio recordings, whereas control participants will receive no such exposure. Preoperative anxiety will be assessed prior to surgery, and pain, mood, reinjury anxiety, and adherence to clinic- and home-based rehabilitation activities will be assessed on a monthly basis for the first six months of postoperative rehabilitation. Measures of range-of-motion, knee laxity, and subjective knee symptoms will again be administered six months after surgery. Successful performance of the CD-ROM and audio recordings in Phase II will result in a product ready for marketing to orthopedic patients and professionals in Phase III.

Technology keywords

Not reported

Agency intelligence

Department of Health and Human Services

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