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.

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.

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.

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.

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.

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.