Clinical Research Network (CRN) update #5: spin-off network studies.

One of the potential benefits of a clinical research network configuration, such as PTClinResNet, is that it allows for tightly focused, smaller studies to be conducted that "spin off" of a larger parent study. These spin-off studies benefit the profession by (1) answering important side questions related to larger issues, (2) demonstrating feasibility for proposed larger studies, and (3) supporting the results and conclusions that are generated from the parent study.

Examples of spin-off studies from each of the CRN projects include:

STEPS (Strength Training Effectiveness Post-Stroke)

* Three researchers--Katherine Sullivan, PT, PhD, at the University of Southern California, in collaboration with Pamela Duncan, PT, PhD, FAPTA, and Andrea Behrman, PT, PhD, at the University of Florida--used the clinical trial experience, preliminary findings, protocol development, and Data Management Center infrastructure from STEPS to obtain the largest rehabilitation trial grant ever funded by the National Institutes of Health (NIH). The NIH's National Institute of Neurological Disorders and Stroke (NINDS) and National Center for Medical Rehabilitation Research (NCMRR) are providing $13.5 million over a 5-year period in support of the "Locomotor Experience Applied Post-Stroke" (LEAPS), a phase III, multisite, randomized clinical trial to investigate the role of timing and intensity of bodyweight--supported treadmill training in the first year, poststroke.

* David Brown, PT, PhD, used the experience and protocols developed with STEPS to obtain $450,000 in funding from the Department of Education's National Institute on Disability and Rehabilitation Research (NIDRR) for his project "Visual Guidance to Improve Stepping Behavior Post Stoke."

* At the Pathokinesiology Laboratory at Rancho Los Amigos National Rehabilitation Center, Sara Mulroy, PT, Katherine Sullivan, PT, PhD, and Tara Klassen, MS, PT, NCS, used the existing data to investigate kinematic and electromyographic parameters of gait in a small cohort of people who underwent the combined strength training and body-weight-supported treadmill training implemented in the parent study.

* At the Balance and Falls Lab at Northwestern University, Mark Rogers, PT, PhD, and David Brown, PT, PhD, investigated stepping responses to an imposed tug at the waist in a small cohort of study participants.

STOMPS (Strengthening and Optimal Movements for Painful Shoulders in Chronic Spinal Cord Injury)

* Sara Mulroy, PT, has submitted an R01 proposal to NCMRR to conduct a prospective, longitudinal study of the development of shoulder joint pain in people with paraplegia from a spinal cord injury.

MUSSEL (The Muscle-Specific Strengthening Effectiveness Post Lumbar Microdiscectomy)

* A proposal for a companion study to assess paraspinal muscle morphology in patients scheduled for microdiscectomy followed by either no restriction of activity or an intense rehabilitative exercise program was submitted to the American Association of Neurological Surgeons.

* Preliminary findings from the MUSSEL study served as pilot data in a recently submitted grant proposal to DePuy Spine Inc. The study aims to assess and compare the morphological and electrophysiological characteristics of back musculature in patients with a history of minimally invasive lumbar spine fusion to those who have undergone a standard fusion technique.

PEDALS (Pediatric Endurance and Limb Strengthening for Children With Cerebral Palsy)

* Two papers, in preparation, are looking at a subset of the subjects recruited for PEDALS. One titled "The Influence of Knee Strength on Knee Kinematics and Kinetics of Children With Cerebral Palsy" compares knee kinematics and kinetics for 2 groups of children, a "stronger" group and a "weaker" group. The second paper covers differences in lower-extremity kinematics and kinetics before and after cycling intervention.

* A resource manual titled Adapting Tricycles for Children With Cerebral Palsy was developed from the experience that the PEDALS team gained in fitting all the children in the study with an appropriate tricycle. This manual and information about the experience will be presented in September at the American Academy of Cerebral Palsy and Developmental Medicine Conference in Boston.

The Network

* Using the CRN data management infrastructure as a model for a multisite clinical trial proposal, the CRN's principal investigator, Carolee Winstein, PT, PhD, University of Southern California, and her colleagues--Steven Wolf, PT, PhD, FAPTA, from Emory University; Alexander Dromerick, MD, of the National Rehabilitation Hospital in Washington, DC; and Stanley Azen, PhD, from the University of Southern California--developed and submitted a proposal to the NINDS for a phase III randomized controlled trial, the Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (I-CARE) Stroke Initiative.

In summary, although the CRN funding was based on the expectation that 4 major studies would be successfully completed, spin-off studies have provided the physical therapy community with additional dividends and future research projects.