Suggested Guidelines for the Prescription of Orthotic Services, Device Delivery, Education, and Follow-up Care: A Multidisciplinary White Paper.

OBJECTIVES: This article establishes needed guidelines for determining orthotic prescriber authority, documenting medical necessity, and ensuring continuity of care for patients needing orthoses. It also identifies "off-the-shelf" (OTS) devices that can safely and appropriately be delivered to patients without professional adjustment as well as those that cannot. METHODS: A multidisciplinary task force made up of experts in orthopedics and physical medicine physicians, along with therapists and certified orthotists, applied a consensus approach to answer key questions: (i) When can a device be safely, effectively delivered to the patient OTS without professional guidance or education, and which caregivers have a role in that decision? (ii) What documentation is appropriate for physicians and other caregivers to determine medical necessity? (iii) What documentation/communication ensures continuity of care among physicians, therapists, and orthotists? RESULTS: Guidelines developed for consideration of OTS orthoses include accepting documentation from collaborating caregivers, including therapists and orthotists; keeping that documentation as part of the patient's total medical record for clinical, medical necessity determinations and reimbursement purposes; and using the physician's prescription for the device as the key determinant of whether a device is delivered OTS or as a custom-fitted device. CONCLUSION: This review provides expert guidance for patient safety, minimizing wasted expenditures, maximizing clinical outcomes, and providing efficient delivery of care for Medicare and other patients. Centers for Medicare and Medicaid Services guidelines should be directed toward recognizing the level of expertise of the orthotist, the value of their patient encounters, and their role in facilitating the timely, safe, and effective use of orthotic devices.

The PEDALS stationary cycling intervention and health-related quality of life in children with cerebral palsy: a randomized controlled trial.

AIM: The aim of this study was to assess health-related quality of life (HRQOL) following a stationary cycling intervention in children with cerebral palsy (CP). METHOD: This was a phase I multisite randomized controlled trial with single blinding. HRQOL was evaluated using the Pediatric Quality of Life Inventory SF15 (PedsQL; children) and Pediatric Outcomes Data Collection Instrument (PODCI; parent proxy) before and after a 3-month stationary cycling intervention. Sixty-two children (29 male, 33 female; mean age 11y; range 7-18y) with spastic diplegic CP, classified as levels I to III on the Gross Motor Function Classification System, were enrolled. Paired and independent t-tests were used to evaluate within- and between-group differences respectively. RESULTS: Between-group differences, favoring the cycling group, were found for PedsQL emotional functioning (p=0.046) and Parental PODCI treatment expectations scores (p=0.006). Between-group differences were not found for other scales. Within-group improvements were found in the cycling group: PedsQL total score (+5.8; p=0.006), psychosocial health summary (+6.9; p=0.008), and school functioning (+8.0; p=0.038). PODCI satisfaction with symptoms decreased significantly only in the control group (-12.0; p=0.046). INTERPRETATION: A beneficial influence of exercise on pediatric emotional well-being and parental treatment expectations was found. The evidence was not strong for other aspects of HRQOL. Results support the positive relationship between physical fitness and emotional well-being in the general population. A child's perception is important when examining change in his or her emotional well-being due to intervention.

Secondary mediation and regression analyses of the PTClinResNet database: determining causal relationships among the International Classification of Functioning, Disability and Health levels for four physical therapy intervention trials.

BACKGROUND: Each of the 4 randomized clinical trials (RCTs) hosted by the Physical Therapy Clinical Research Network (PTClinResNet) targeted a different disability group (low back disorder in the Muscle-Specific Strength Training Effectiveness After Lumbar Microdiskectomy [MUSSEL] trial, chronic spinal cord injury in the Strengthening and Optimal Movements for Painful Shoulders in Chronic Spinal Cord Injury [STOMPS] trial, adult stroke in the Strength Training Effectiveness Post-Stroke [STEPS] trial, and pediatric cerebral palsy in the Pediatric Endurance and Limb Strengthening [PEDALS] trial for children with spastic diplegic cerebral palsy) and tested the effectiveness of a muscle-specific or functional activity-based intervention on primary outcomes that captured pain (STOMPS, MUSSEL) or locomotor function (STEPS, PEDALS). OBJECTIVE: The focus of these secondary analyses was to determine causal relationships among outcomes across levels of the International Classification of Functioning, Disability and Health (ICF) framework for the 4 RCTs. METHOD AND DESIGN: With the database from PTClinResNet, we used 2 separate secondary statistical approaches-mediation analysis for the MUSSEL and STOMPS trials and regression analysis for the STEPS and PEDALS trials-to test relationships among muscle performance, primary outcomes (pain related and locomotor related), activity and participation measures, and overall quality of life. RESULTS: Predictive models were stronger for the 2 studies with pain-related primary outcomes. Change in muscle performance mediated or predicted reductions in pain for the MUSSEL and STOMPS trials and, to some extent, walking speed for the STEPS trial. Changes in primary outcome variables were significantly related to changes in activity and participation variables for all 4 trials. Improvement in activity and participation outcomes mediated or predicted increases in overall quality of life for the 3 trials with adult populations. LIMITATIONS: Variables included in the statistical models were limited to those measured in the 4 RCTs. It is possible that other variables also mediated or predicted the changes in outcomes. The relatively small sample size in the PEDALS trial limited statistical power for those analyses. CONCLUSIONS: Evaluating the mediators or predictors of change between each ICF level and for 2 fundamentally different outcome variables (pain versus walking) provided insights into the complexities inherent across 4 prevalent disability groups.

Stationary cycling and children with cerebral palsy: case reports for two participants.

These case reports describe a stationary cycling intervention and outcomes for two child participants (P1 and P2) with spastic diplegic cerebral palsy. Each child completed a 12-week, 30-session cycling intervention consisting of strengthening and cardiorespiratory fitness phases. P1 exhibited higher training intensities, particularly during the cardiorespiratory phase. Average training heart rates were 59% and 35% of maximum heart rate for P1 and P2, respectively. Lower extremity peak knee flexor and extensor moments, gross motor function (Gross Motor Function Measure (GMFM-66)), preferred walking speed (thirty-second walk test), and walking endurance (600-yard walk-run test) were measured pre- and postintervention. Changes in outcome measurements corresponded with differences in exercise intensity. Greater gains in peak knee extensor moments, GMFM-66 scores (+4.2 versus +0.9), 600-yard walk-run test (-29% versus 0%) occurred for P1 versus P2, respectively. Preferred walking speeds did not increase substantially for P1 and decreased for P2.

Pediatric endurance and limb strengthening (PEDALS) for children with cerebral palsy using stationary cycling: a randomized controlled trial.

BACKGROUND: Effective interventions to improve and maintain strength (force-generating capacity) and endurance are needed for children with cerebral palsy (CP). OBJECTIVE: This study was performed to examine the effects of a stationary cycling intervention on muscle strength, locomotor endurance, preferred walking speed, and gross motor function in children with spastic diplegic CP. DESIGN: This was a phase I randomized controlled trial with single blinding. SETTING: The interventions were performed in community-based outpatient physical therapy clinics. Outcome assessments were performed in university laboratories. PARTICIPANTS: Sixty-two ambulatory children aged 7 to 18 years with spastic diplegic CP and Gross Motor Function Classification System levels I to III participated in this study. INTERVENTION AND MEASUREMENTS: Participants were randomly assigned to cycling or control (no-intervention) groups. Thirty intervention sessions occurred over 12 weeks. Primary outcomes were peak knee extensor and flexor moments, the 600-Yard Walk-Run Test, the Thirty-Second Walk Test, and the Gross Motor Function Measure sections D and E (GMFM-66). RESULTS: Significant baseline-postintervention improvements were found for the 600-Yard Walk-Run Test, the GMFM-66, peak knee extensor moments at 120 degrees /s, and peak knee flexor moments at 30 degrees /s for the cycling group. Improved peak knee flexor moments at 120 degrees/s were found for the control group only, although not all participants could complete this speed of testing. Significant differences between the cycling and control groups based on change scores were not found for any outcomes. Limitations Heterogeneity of the patient population and intrasubject variability were limitations of the study. CONCLUSIONS: Significant improvements in locomotor endurance, gross motor function, and some measures of strength were found for the cycling group but not the control group, providing preliminary support for this intervention. As statistical differences were not found in baseline-postintervention change scores between the 2 groups; the results did not demonstrate that stationary cycling was more effective than no intervention. The results of this phase I study provide guidance for future research.

Pediatric endurance and limb strengthening for children with cerebral palsy (PEDALS)--a randomized controlled trial protocol for a stationary cycling intervention.

BACKGROUND: In the past, effortful exercises were considered inappropriate for children with spastic cerebral palsy (CP) due to concern that they would escalate abnormalities including spasticity and abnormal movement patterns. Current scientific evidence indicates that these concerns were unfounded and that therapeutic interventions focused on muscle strengthening can lead to improved functional ability. However, few studies have examined the potential benefits of cardiorespiratory fitness exercises in this patient population. METHODS/DESIGN: The rationale and design of a randomized controlled trial examining the effects of a stationary cycling intervention for children with CP are outlined here. Sixty children with spastic diplegic CP between the ages of 7 and 18 years and Gross Motor Function Classification System (GMFCS) levels of I, II, or III will be recruited for this study. Participants will be randomly assigned to either an intervention (cycling) or a control (no cycling) group. The cycling intervention will be divided into strengthening and cardiorespiratory endurance exercise phases. During the strengthening phase, the resistance to lower extremity cycling will be progressively increased using a uniquely designed limb-loaded mechanism. The cardiorespiratory endurance phase will focus on increasing the intensity and duration of cycling. Children will be encouraged to exercise within a target heart rate (HR) range (70-80% maximum HR). Thirty sessions will take place over a 10-12 week period. All children will be evaluated before (baseline) and after (follow-up) the intervention period. Primary outcome measures are: knee joint extensor and flexor moments, or torque; the Gross Motor Function Measure (GMFM); the 600 Yard Walk-Run test and the Thirty-Second Walk test (30 sec WT). DISCUSSION: This paper presents the rationale, design and protocol for Pediatric Endurance and Limb Strengthening (PEDALS); a Phase I randomized controlled trial evaluating the efficacy of a stationary cycling intervention for children with spastic diplegic cerebral palsy.