Physical Therapy Dose After Orthopedic Multilevel Surgery Varies by Ambulatory Status in Children With Cerebral Palsy: A Pilot Study.

PURPOSE: To characterize physical therapy (PT) dose for children with cerebral palsy (CP) after multi-level surgery (MLS) and examine variation by ambulatory status and surgical burden. METHODS: PT dose (Frequency, Intensity, Time, Type) data were extracted from electronic records of children with CP who received outpatient PT the year after MLS. RESULTS: Seventeen children, mean 9 years, female (n=10), ambulatory (n=10), and high surgical burden (n=12) were included. In the year after surgery, 345 visits occurred. Intensity across visits was above average. Time was greatest for pre-functional activities, gait, and transitions/transfers. Types most often delivered were neuromuscular, musculoskeletal, and education/training. Ambulatory children received significantly more visits, higher intensity, and time in pre-functional activities and gait than non-ambulatory children. No differences in type by ambulatory status and PT dose by surgical burden were found. CONCLUSION: PT dose varied the first year after MLS indicating the need for guidelines by ambulatory status. VIDEO ABSTRACT: Supplemental Digital Content available at: http://links.lww.com/PPT/A516.

Gross motor function prediction using natural language processing in cerebral palsy.

AIM: To predict ambulatory status and Gross Motor Function Classification System (GMFCS) levels in patients with cerebral palsy (CP) by applying natural language processing (NLP) to electronic health record (EHR) clinical notes. METHOD: Individuals aged 8 to 26 years with a diagnosis of CP in the EHR between January 2009 and November 2020 (~12 years of data) were included in a cross-sectional retrospective cohort of 2483 patients. The cohort was divided into train-test and validation groups. Positive predictive value, sensitivity, specificity, and area under the receiver operating curve (AUC) were calculated for prediction of ambulatory status and GMFCS levels. RESULTS: The median age was 15 years (interquartile range 10-20 years) for the total cohort, with 56% being male and 75% White. The validation group resulted in 70% sensitivity, 88% specificity, 81% positive predictive value, and 0.89 AUC for predicting ambulatory status. NLP applied to the EHR differentiated between GMFCS levels I-II and III (15% sensitivity, 96% specificity, 46% positive predictive value, and 0.71 AUC); and IV and V (81% sensitivity, 51% specificity, 70% positive predictive value, and 0.75 AUC). INTERPRETATION: NLP applied to the EHR demonstrated excellent differentiation between ambulatory and non-ambulatory status, and good differentiation between GMFCS levels I-II and III, and IV and V. Clinical use of NLP may help to individualize functional characterization and management. WHAT THIS PAPER ADDS: Natural language processing (NLP) applied to the electronic health record (EHR) can predict ambulatory status in children with cerebral palsy (CP). NLP provides good prediction of Gross Motor Function Classification System level in children with CP using the EHR. NLP methods described could be integrated in an EHR system to provide real-time information.

Inpatient Physical Therapy After Orthopedic Lower Extremity Surgery in Children With Cerebral Palsy.

PURPOSE: To characterize and examine the variability in receipt of inpatient (IP) physical therapy after lower extremity (LE) orthopedic surgery for individuals with cerebral palsy (CP) across hospital-level (region, bed size) and individual characteristics (gender, age, race/ethnicity, insurance type, technology dependency, and surgical burden). METHODS: We retrospectively analyzed physical therapy billing data of children with CP who had LE orthopedic surgery from October 1, 2015, through September 30, 2017, from the Pediatric Health Information Services (PHIS) database. RESULTS: Seventy-five percent of individuals received IP physical therapy during the hospital stay. Individuals from the South and West and those who were technology dependent were less likely to receive IP therapy. Those at large hospitals, aged 11 to 14 years, and with a high surgical burden were more likely to receive therapy. CONCLUSIONS: Results provide a starting point for future research on the discrepancies of acute physical therapy services in children diagnosed with CP. (Supplemental digital content video abstract available at: http://links.lww.com/PPT/A420).

Infants With Congenital Muscular Torticollis: Demographic Factors, Clinical Characteristics, and Physical Therapy Episode of Care.

PURPOSE: To describe demographic factors, baseline characteristics, and physical therapy episodes in infants with congenital muscular torticollis (CMT), examine groups based on physical therapy completion, and identify implications for clinical practice. METHODS: Retrospective data were extracted from a single-site registry of 445 infants with CMT. RESULTS: Most infants were male (57%), Caucasian (63%), and firstborn (50%), with torticollis detected by 3 months old (89%) with a left (51%), mild (72%) CMT presentation. Cervical range of motion (ROM) limitations were greatest in passive lateral flexion and active rotation. Sixty-seven percent of infants completed an episode of physical therapy, 25% completed a partial episode, and 8% did not attend visits following the initial examination. Age at examination, ROM, and muscle function differed significantly between groups. CONCLUSIONS: Physical therapists may use clinical registry data to inform practice for timing of referral, frequency of care, and clinician training to manage infants with CMT.

Electronic health record and patterns of care for children with cerebral palsy.

AIM: To characterize the patterns of care of children with cerebral palsy (CP) in a tertiary healthcare system. METHOD: Electronic health record data from 2009 to 2019 were extracted for children with CP. Machine learning hierarchical clustering was used to identify clusters of care. The ratio of in-person to care coordination visits was calculated for each specialty. RESULTS: The sample included 6369 children with CP (55.7% males, 44.3% females, 76.2% white, 94.7% non-Hispanic; with a mean age of 8y 2mo [SD 5y 10mo; range 0-21y; median 7y 1mo]) at the time of diagnosis. A total of 3.7 million in-person visits and care coordination notes were identified across 34 specialties. The duration of care averaged 5 years 5 months with five specialty interactions and 21.8 in-person visits per year per child. Seven clusters of care were identified, including: musculoskeletal and function; neurological; high-frequency/urgent care services; procedures; comorbid diagnoses; development and behavioral; and primary care. Network analysis showed shared membership among several clusters. INTERPRETATION: Coordination of care is a central element for children with CP. Medical informatics, machine learning, and big data approaches provide unique insights into care delivery to inform approaches to improve outcomes for children with CP. What this paper adds Seven primary clusters of care were identified: musculoskeletal and function; neurological; high-frequency/urgent care services; procedures; comorbid diagnoses; development and behavioral; and primary care. The in-person to care coordination visit ratio was 1:5 overall for healthcare encounters. Most interactions with care teams occur outside of in-person visits. The ratio of in-person to care coordination activities differ by specialty.

Describing the Delivery of Evidence-Based Physical Therapy Intervention to Individuals With Cerebral Palsy.

PURPOSE: To characterize by evidence grades and examine variation in type of physical therapy intervention delivered in routine clinical care in individuals with cerebral palsy (CP). METHODS: Retrospective data collection from the electronic record over 1 year at a tertiary care pediatric outpatient therapy division. RESULTS: Four hundred sixty-five individuals with CP received 28 344 interventions during 4335 treatment visits. Sixty-six percent of interventions were evidence-based interventions (EBIs). Significant variation was demonstrated across Gross Motor Function Classification System levels, with children classified as level V receiving the least and level III the most. The most frequent EBIs delivered were caregiver education, motor control, functional strengthening, ankle-foot orthoses, treadmill training, and fit of adaptive equipment. CONCLUSIONS: Further work is needed to determine whether amount of EBI is related to better outcomes. Combining this information with other aspects of dose (intensity, time, and frequency) may elucidate the contribution of each with outcomes.

Adapted Dance Improves Motor Abilities and Participation in Children With Down Syndrome: A Pilot Study.

PURPOSE: This pilot study measured effects of an adapted dance program on motor abilities and participation in children with Down syndrome (DS) and explored caregivers' qualitative feedback regarding its benefits. METHODS: Children with DS participated in 20 weekly 1-hour adapted dance sessions. The Canadian Occupational Performance Measure (COPM) and Gross Motor Function Measure (GMFM) Dimensions D and E were administered before and after the program. Caregivers completed a survey at the last session. RESULTS: Six children completed pre- and postassessments. Significant improvements were noted in GMFM-88 measures. Caregivers of 5 participants reported improved scores on the COPM that were not significant. Caregivers reported physical, cognitive, and emotional improvements. CONCLUSIONS: This study supports use of an adapted dance program to improve motor abilities and participation in children with DS. VIDEO ABSTRACT: For more insights from the authors, access Supplemental Digital Content 1, available at: http://links.lww.com/PPT/A231.

Documenting Physical Therapy Dose for Individuals With Cerebral Palsy: A Quality Improvement Initiative.

PURPOSE: To describe the quality improvement (QI) activities used to improve treatment dose documentation for individuals with cerebral palsy (CP) and to discuss insights gained from this project. METHODS: Global and smart aims were established and interventions were tested from January 2017 through February 2018 using Plan-Do-Study-Act cycles. Performance was tracked overtime using run and control charts. RESULTS: The QI initiative resulted in a sustainable increase in percentage of dose elements present in the electronic medical record from 78% to 94%. Key drivers of improvement included (1) knowledge and awareness of dose, (2) clinician buy-in, (3) effective engagement of child and parent, (4) therapist knowledge of evidence-based treatments, (5) transparent and reliable documentation system, and (6) audit and clinician feedback. CONCLUSIONS: QI methods provided the tools to improve workflow and increase dose documentation for individuals with CP.

Setting a patient-centered research agenda for cerebral palsy: a participatory action research initiative.

AIM: To establish a patient-centered research agenda for cerebral palsy (CP). METHOD: We engaged a large cross-section of the extended community of people living with CP and those providing healthcare to people with CP ('the community') in an educational series and collaborative survey platform to establish an initial list of prioritized research ideas. After online workshops, a facilitated Delphi process was used to select the 20 highest priorities. Select participants attended an in-person workshop to provide comment and work toward consensus of research priorities. RESULTS: A research agenda for CP was developed by the community, which included consumers, clinicians, and researchers interested in advancing the established research agenda. The results included the top 16 research concepts produced by the process to shape and steward the research agenda, and an engaged cross-section of the community. INTERPRETATION: It has been shown that proactively engaging consumers with clinical researchers may provide more meaningful research for the community. This study suggests that future research should have more focus on interventions and outcomes across the lifespan with increased emphasis on the following outcome measures: function, quality of life, and participation. WHAT THIS PAPER ADDS: A patient-centered research agenda for cerebral palsy was established. Comparative effectiveness of interventions, physical activity, and understanding ageing were leading themes. Longitudinal studies across the lifespan, clinical spectrum, and ages were highly ranked. Participants reported high value for participation outcomes. Participants reported great appreciation for the engagement between consumers and clinician researchers.

Caregiver knowledge and preferences for gross motor function information in cerebral palsy.

AIM: To determine caregiver knowledge and preferences for gross motor information and examine differences across Gross Motor Function Classification System (GMFCS) levels. METHOD: A questionnaire was developed. Respondents reported GMFCS knowledge, preference for knowledge, and experience with GMFCS and motor curve information. RESULTS: In total, 303 caregivers of children with cerebral palsy (CP) (GMFCS level I: 22%; GMFCS level II: 16%; GMFCS level III: 15%; GMFCS level IV: 23%; GMFCS level V: 24%) completed the questionnaire. Forty-five per cent of caregivers knew the GMFCS level at survey, and only 31% knew how their child's motor development compared with others of similar age and level. Caregiver education level was associated with knowledge (p<0.001). Most prefer discussing motor development with a therapist. Of caregivers who knew their child's GMFCS level at survey, 83% reported it would be helpful to revisit the topic over time. Compared with GMFCS level IV and V, caregivers of children in GMFCS levels I to III preferred to learn at the same time as CP diagnosis, (p=0.04) and were more likely to report having received visual aids (p=0.04). Caregivers of children in GMFCS levels IV and V found it more difficult to learn their child's level (p<0.001) versus those caring for children of GMFCS levels I to III, and reported seeing pictures with descriptions more informative (p=0.03). INTERPRETATION: Caregivers of children with CP may not know GMFCS and motor curve information, and vary in experience and preferences for this information. WHAT THIS PAPER ADDS: Fewer than half of caregivers of children with cerebral palsy (CP) know their child's Gross Motor Function Classification System level. Most want to know how their child's function compares to other children with CP. The majority of caregivers would like to revisit the topic over time. Caregivers want to discuss gross motor information with the therapist and doctor.

Comparative Effectiveness Research and Children With Cerebral Palsy: Identifying a Conceptual Framework and Specifying Measures.

PURPOSE: A step toward advancing research about rehabilitation service associated with positive outcomes for children with cerebral palsy is consensus about a conceptual framework and measures. METHODS: A Delphi process was used to establish consensus among clinicians and researchers in North America. RESULTS: Directors of large pediatric rehabilitation centers, clinicians from large hospitals, and researchers with expertise in outcomes participated (N = 18). Andersen's model of health care utilization framed outcomes: consumer satisfaction, activity, participation, quality of life, and pain. Measures agreed upon included Participation and Environment Measure for Children and Youth, Measure of Processes of Care, PEDI-CAT, KIDSCREEN-10, PROMIS Pediatric Pain Interference Scale, Visual Analog Scale for pain intensity, PROMIS Global Health Short Form, Family Environment Scale, Family Support Scale, and functional classification levels for gross motor, manual ability, and communication. CONCLUSIONS: Universal forms for documenting service use are needed. Findings inform clinicians and researchers concerned with outcome assessment.

A big data approach to evaluate receipt of optimal care in childhood cerebral palsy.

PURPOSE: Through automated electronic health record (EHR) data extraction and analysis, this project systematically quantified actual care delivery for children with cerebral palsy (CP) and evaluated alignment with current evidence-based recommendations. METHODS: Utilizing EHR data for over 8000 children with CP, we developed an approach to define and quantify receipt of optimal care, and pursued proof-of-concept with two children with unilateral CP, Gross Motor Function Classification System (GMFCS) Level II. Optimal care was codified as a cluster of four components including physical medicine and rehabilitation (PMR) care, spasticity management, physical therapy (PT), and occupational therapy (OT). A Receipt of Care Score (ROCS) quantified the degree of adherence to recommendations and was compared with the Pediatric Outcomes Data Collection Instrument (PODCI) and Pediatric Quality of Life Inventory (PEDS QL). RESULTS: The two children (12 year old female, 13 year old male) had nearly identical PMR and spasticity component scores while PT and OT scores were more divergent. Functional outcomes were higher for the child who had higher adjusted ROCS. CONCLUSIONS: ROCSs demonstrate variation in real-world care delivered over time and differentiate between components of care. ROCSs reflect overall function and quality of life. The ROCS methods developed are novel, robust, and scalable and will be tested in a larger sample.IMPLICATIONS FOR REHABILITATIONOptimal practice, with an emphasis on integrated multidisciplinary care, can be defined and quantified utilizing evidence-based recommendations.Receipt of optimal care for childhood cerebral palsy can be scored using existing electronic health record data.Big Data approaches can contribute to the understanding of current care and inform approaches for improved care.

Mental Health Diagnoses Risk Among Children and Young Adults With Cerebral Palsy, Chronic Conditions, or Typical Development.

Importance: Mental health (MH) issues in children with cerebral palsy (CP) are poorly understood compared with other pediatric populations. Objective: To examine MH diagnosis code assignment among children and young adults with CP and compare with typically developing (TD) and chronic condition (CC) pediatric populations. Design, Setting, and Participants: This case-control study used International Statistical Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes to create a CP case set and CC and TD control sets using electronic health record data of children and young adults from a large tertiary care children's hospital in the midwestern United States between 2010 and 2022. Case-control matching was performed to control for demographic factors. Data were analyzed from June to December 2023. Exposures: All MH diagnosis codes were mapped to ICD-10-CM and categorized using Clinical Classifications Software Refined (CCSR). Main Outcomes and Measures: The incidence rates of MH CCSR categories were calculated. Descriptive and comparative statistics were used to evaluate the significance and odds associated with factors. Results: Data from 216 794 individuals (mean [SD] baseline age, 4.3 [5.1] years; 118 562 [55%] male) were analyzed, including 3544 individuals with CP, 142 160 individuals with CC, and 71 080 TD individuals. The CP cohort spread across Gross Motor Function Classification System (GMFCS) levels I (981 individuals [28%]), II (645 individuals [18%]), III (346 individuals [10%]), IV (502 individuals [14%]), and V (618 individuals [17%]). Rates varied significantly for anxiety (824 individuals with CP [23%]; 25 877 individuals with CC [9%]; 6274 individuals with TD [18%]), attention-deficit/hyperactivity disorder (534 individuals with CP [15%]; 22 426 individuals with CC [9%]; 6311 individuals with TD [16%]); conduct or impulse disorder (504 individuals with CP [14%]; 13 209 individuals with CC [5%]; 3715 individuals with TD [9%]), trauma or stress disorders (343 individuals with CP [10%]; 18 229 individuals with CC [8%]; 5329 individuals with TD [13%]), obsessive-compulsive disorder (251 individuals with CP [7%]; 3795 individuals with CC [1%]; 659 individuals with TD [3%]), depression (108 individuals with CP [3%]; 12 224 individuals with CC [5%]; 4007 individuals with TD [9%]), mood disorders (74 individuals with CP [2%]; 4355 individuals with CC [2%]; 1181 individuals with TD [3%]), and suicidal ideation (72 individuals with CP [2%]; 7422 individuals with CC [5%]; 3513 individuals with TD [5%]). There was significant variation in odds of MH diagnoses by GMFCS level (I-II vs III-V: odds ratio [OR], 1.23; 95% CI, 1.09-1.40; P = .001). Among individuals with CP, males were more likely than females to have diagnosis codes for conduct or impulse disorders (OR, 1.41; 95% CI, 1.16-1.73) and attention-deficit/hyperactivity disorder (OR, 1.41 [95% CI, 1.15-1.73]). Black individuals, compared with White individuals, were more likely to have diagnoses for obsessive-compulsive disorder (OR, 1.57 [95% CI, 1.14-2.16]), other mood disorders (OR, 1.85 [95% CI, 1.01-3.38]), and trauma or stress disorders (OR, 1.94 [95% CI, 1.44-2.63]). Odds for trauma or stress disorders were elevated for individuals who identified as other races compared with White individuals (OR, 2.80 [95% CI, 2.03-3.87]). Conclusions and Relevance: In this case-control study of children and young adults with CP and matched comparisons, anxiety and conduct or impulse diagnoses were higher in individuals with CP. The lower diagnosis rates of depression and suicidal ideation may indicate underdiagnosis among individuals with CP. There is likely a need for assessment tools that are more suitable for children with CP.

White matter characteristics in children with cerebral palsy prior to selective dorsal rhizotomy: a multicenter diffusion tensor imaging study.

OBJECTIVE: The aims of this study were to 1) assess and quantify white matter (WM) microstructural characteristics derived from diffusion tensor imaging (DTI) in children with cerebral palsy (CP) prior to selective dorsal rhizotomy (SDR), and 2) investigate potential associations between WM diffusion properties and gross motor function and spasticity in children with spastic CP who underwent SDR. METHODS: This study is a multisite study based on DT images acquired prior to SDR as well as postoperative outcome data. DTI data collected from two sites were harmonized using the ComBat approach to minimize intersite scanner difference. The DTI abnormalities between children with spastic CP and controls were analyzed and correlated with the severity of impaired mobility based on the Gross Motor Function Classification System (GMFCS). The improvement in gross motor function and spasticity after SDR surgery was assessed utilizing the Gross Motor Function Measure-66 (GMFM-66), the Modified Tardieu Scale (MTS), and the modified Ashworth scale (MAS). Alterations in these outcome measures were quantified in association with DTI abnormalities. RESULTS: Significant DTI alterations, including lower fractional anisotropy (FA) in the genu of the corpus callosum (gCC) and higher mean diffusivity (MD) in the gCC and posterior limb of the internal capsule (PLIC), were found in children in the SDR group when compared with the age-matched control group (all p < 0.05). Greater DTI alterations (FA in gCC and MD in gCC and PLIC) were associated with lower mobility levels as determined based on GMFCS level (p < 0.05). The pre- to post-SDR improvement in motor function based on GMFM-66 was statistically significant (p = 0.006 and 0.002 at 6-month and 12-month follow-ups, respectively). The SDR efficacy was also identified as improving spasticity in lower-extremity muscle groups assessed with the MTS and MAS. Partial correlation analysis presented a significant association between pre- to post-SDR MTS alteration and DTI abnormalities. CONCLUSIONS: The findings in the present study provided initial quantitative evidence to establish the WM microstructural characteristics in children with spastic CP prior to SDR surgery. The study generated data for the association between baseline DTI characteristics and mobility in children with CP prior to SDR surgery. The study also demonstrated SDR efficacy in improving motor function and spasticity based on the GMFM-66, MTS, and MAS, respectively, in association with DTI data.

Outpatient hospital utilization after single event multi-level surgery in children with cerebral palsy.

PURPOSE: This study aimed to examine outpatient hospital utilization (number of specialties seen and number of visits to each specialty) in the year after single event multi-level surgery (SEMLS) in children with cerebral palsy (CP), and to determine if utilization differs across the medical center in the year after compared to the year before SEMLS. METHODS: This retrospective cross-sectional study used electronic medical record data of outpatient hospital utilization in children with CP who underwent SEMLS. RESULTS: Thirty children with CP (Gross Motor Function Classification System Levels I-V, mean age of 9.9 years) were included. In the year after surgery, a significant difference (p = 0.001) was found for the number of specialties seen, with non-ambulatory children seeing more specialties than ambulatory children. No statistically significant difference was found between the number of outpatient visits to each specialty in the year after SEMLS. Compared to the year before SEMLS, fewer therapy visits occurred in the year after SEMLS (p < 0.001) but significantly more visits to orthopaedics (p = 0.001) and radiology (p = 0.001). CONCLUSION: Children with CP had fewer therapy visits but more orthopaedic and radiology visits the year after SEMLS. Nearly half of the children were non-ambulatory. Examination of care needs in children with CP undergoing SEMLS is justified with consideration of ambulatory status, surgical burden, and post-operative immobilization.

A multicenter initiative to reduce intrathecal baclofen pump surgical site infection: a Cerebral Palsy Research Network quality improvement project.

OBJECTIVE: Intrathecal baclofen (ITB) therapy is an effective treatment for spasticity and dystonia in children with cerebral palsy (CP). However, ITB pump surgery is associated with one of the highest rates of surgical site infection (SSI) in medicine, leading to significant morbidity and expense. Surgical protocols have reduced the rate of SSI in children with other CNS implants, and single-center protocols have been effective in ITB surgery in pediatrics. The authors describe the first multicenter quality improvement (QI)-driven standardized protocol for ITB pump surgery in children with CP across the Cerebral Palsy Research Network (CPRN), implemented with the aim of reducing ITB-associated SSI. METHODS: SSI was defined as a culture-positive infection, ITB pump system removal for suspected infection, or wound dehiscence with exposed hardware. Each center reported historical infection rates for at least 3 years before initiating the SSI protocol (preintervention phase). After initiation of a 13-step surgical protocol, a consecutive series of 130 patients undergoing 149 surgical procedures for ITB at four CPRN tertiary pediatric neurosurgery centers were prospectively enrolled at surgery during a 2-year study period (intervention phase). QI methodology was used, including development of a key driver diagram and tracking performance using run and control charts. The primary process measure goal was documented compliance with 80% of the protocol steps, and the primary outcome measure goal was a 20% reduction in 90-day infection rate. Patient characteristics were collected from the CPRN Research Electronic Data Capture registry, including age at surgery, BMI, Gross Motor Function Classification System level, and pattern of spasticity. RESULTS: The aggregated preintervention 90-day ITB SSI rate was 4.9% (223 procedures) between 2014 and 2017. During the intervention phase, 136 of 149 ITB surgeries performed met inclusion criteria for analysis. The mean documented compliance rate with protocol steps was 75%, and the 90-day infection rate was 4.4%, with an average of 42 days from index surgery to infection. CONCLUSIONS: This is the first multicenter QI initiative designed to reduce SSI in ITB surgery in children with CP. Ongoing enrollment and expansion of the protocol to other CPRN centers will facilitate identification of patient- and procedure-specific risk factors for SSI, and iterative plan-do-study-act cycles incorporating these data will further decrease the risk of SSI for ITB surgery in children.

The effect of suit wear during an intensive therapy program in children with cerebral palsy.

PURPOSE: To examine the effects of suit wear during an intensive therapy program on motor function among children with cerebral palsy. METHOD: Twenty children were randomized to an experimental (TheraSuit) or a control (control suit) group and participated in an intensive therapy program. The Pediatric Evaluation of Disability Inventory (PEDI) and Gross Motor Function Measure (GMFM)-66 were administered before and after (4 and 9 weeks). Parent satisfaction was also assessed. RESULTS: No significant differences were found between groups. Significant within-group differences were found for the control group on the GMFM-66 and for the experimental group on the GMFM-66, PEDI Functional Skills Self-care, PEDI Caregiver Assistance Self-care, and PEDI Functional Skills Mobility. No adverse events were reported. CONCLUSIONS: Children wearing the TheraSuit during an intensive therapy program did not demonstrate improved motor function compared with those wearing a control suit during the same program.