Results Summary and Professional Abstract

Results Summary

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Results Summary

What was the research about?

Almost 230,000 children in the United States have cerebral palsy, or CP. CP is a health problem that affects motor skills, which include the ability to move and to maintain balance and posture. Physical therapy, or PT, is one way to improve motor skills. PT includes exercises, repeated activities, and other actions to improve motor and mental skills.

In this study, the research team compared two PT schedules for children with CP. The first was one hour of PT once a week for 40 weeks. The second was two periods of 10 weekdays each, where children got two hours of PT each day. The team compared how well these two schedules improved children’s health and well-being. They looked at

• Motor skills and ability to move
• Physical development
• Ability to do activities independently
• Quality of life, social function, and involvement in community activities

The research team also looked at how parents rated working with physical therapists.

What were the results?

Children in both physical therapy groups had improved motor skills and other health outcomes. The two schedules didn’t make a difference in the amount of improvement. Parents in both groups gave positive ratings to working with therapists.

Who was in the study?

The study included 100 children ages 2–8 with cerebral palsy. The average age was 5 years, and 55 percent were boys.

What did the research team do?

The research team first assigned children by chance to one of two PT schedules. If parents didn’t want their children to be assigned by chance, the team let parents choose one of the PT schedules. The team assigned 46 children by chance, while parents of 54 children chose their PT schedule. Of these parents, 26 chose weekly PT and 28 chose everyday PT. Licensed and trained physical therapists provided the PT. The team looked at health outcomes before children started PT and again nine months later.

Parents of children with cerebral palsy, an adult with cerebral palsy, and cerebral palsy support groups helped plan the study.

What were the limits of the study?

Fewer children took part in the study than expected, making it hard to find differences in health outcomes. Future studies could look at how to better support patients with cerebral palsy to take part in studies comparing PT schedules.

How can people use the results?

Parents of children with CP and their healthcare providers can use these results when considering PT schedules.

Professional Abstract

Professional Abstract

Objective

To compare the effectiveness of regular weekly physical therapy versus intensive periodic physical therapy for improving motor function in children with cerebral palsy

Study Design

Design Element	Description
Design	Observational cohort study
Population	100 children ages 2–8 with cerebral palsy (46 in randomized cohort and 54 in nonrandomized cohort)
Interventions/ Comparators	Weekly regular physical therapy, involving 1 hour of physical therapy once a week for 40 weeks Intensive periodic physical therapy, involving 2 hours of physical therapy every weekday for two 10-consecutive-weekday periods
Outcomes	Primary: motor function Secondary: child development; involvement in community activities; health-related quality of life; self-care, mobility, and social function; parent rating of interactions with therapist
Timeframe	9-month follow-up for primary outcome

This observational cohort study compared the effectiveness of regular weekly physical therapy versus intensive periodic physical therapy on improving motor function and other measures of function and well-being in children with cerebral palsy.

Researchers initially randomized children to one of two physical therapy schedules. In the first schedule, children had regular physical therapy, which involved one hour of physical therapy once a week for 40 consecutive weeks. In the second schedule, children had intensive physical therapy, which involved two hours of physical therapy per day for two 10-consecutive-weekday periods.

Licensed and trained pediatric physical therapists provided physical therapy in an outpatient setting. To increase patient recruitment, participants who declined randomization were permitted to participate and to choose one of the physical therapy schedules. Researchers randomized 46 children, while 54 children were in the nonrandomized cohort. Of children in the nonrandomized cohort, 26 received regular physical therapy and 28 received intensive physical therapy. Researchers assessed outcomes before children started physical therapy and again nine months later.

The study included 100 children ages 2–8 with a diagnosis of cerebral palsy. The average age was 5, and 55% were male.

Parents of children with cerebral palsy, an adult patient with cerebral palsy, and cerebral palsy support organizations helped plan the study.

Results

For both the randomized and non-randomized cohorts,

• Both physical therapy groups had improvements in motor function and all secondary outcomes (all p<0.05).
• The two groups did not differ in the amount of improvement in motor function or the secondary outcomes.
• Parents in both groups reported positive ratings of interactions with therapists.

Limitations

Researchers recruited and retained fewer children than planned, which may have affected their ability to detect differences between the groups.

Conclusions and Relevance

In this study, regular weekly physical therapy and intensive periodic physical therapy schedules did not differ in improvements in motor function and other outcomes in children with cerebral palsy.

Future Research Needs

Future research could examine how to better recruit and retain patients with cerebral palsy in studies comparing physical therapy schedules.

More on this Project  

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

• The reviewers cautioned the researchers against concluding that there were no primary outcome differences between the weekly and high-intensity physical therapy treatment arms. The reviewers noted that the study did not achieve its anticipated sample size, so the lack of difference comparative improvement could be the result of insufficient power to find the effect rather than an indication that there really is no difference. The researchers acknowledged this alternate interpretation of their study findings and changed their discussion to note that their conclusions of equivalency between the treatment arms should be tempered given low power and wide variation in the results.
• The reviewers also cautioned the researchers about their conclusions because the study’s sample size was small and loss to follow-up was high. The researchers disagreed that the sample size was small, stating that the sample size would be considered medium or large in pediatric rehabilitation studies. The researchers did revise their report to emphasize the power analysis and low power of the study, but also noted that there are few studies of long-term outcomes in pediatric physical rehabilitation, so the results are still a major contribution to the field.
• Reviewers commented that the study took an ableist perspective, based on the medical model of disability, with the goal of changing people to experience more typical development, rather than the social model which suggests society should change to create supports for individuals with disabilities so they can participate more fully in life. The researchers edited the report to acknowledge the social model of disability, reduce language that may be perceived as ableist, and state that this study took place within the medical model of care.

Conflict of Interest Disclosures

View the COI disclosure form.

Project Details

Principal Investigator

Jill C. Heathcock, MPT, PhD

Project Status

Completed; PCORI Public and Professional Abstracts Posted

Project Title

Comparing Two Schedules of Physical Therapy for Children with Cerebral Palsy

Board Approval Date

May 2016

Project End Date

October 2020

Organization

The Ohio State University

Year Awarded

2016

State

Ohio

Year Completed

2021

Project Type

Research Project

Health Conditions  

Neurological Disorders

Cerebral Palsy

Rare Diseases

Intervention Strategies

Other Clinical Interventions

Populations

Children -- 18 and under
Individuals with Disabilities
Individuals with Multiple Chronic/co-morbid Conditions
Individuals with Rare Disease

Funding Announcement

Assessment of Prevention, Diagnosis, and Treatment Options

Project Budget

$2,472,372

Study Registration Information

HSRP20163076

NCT02897024

Partners

Patient/Caregiver Partners

Erin Thomas, adult patient Nathalie Maitre, parent Clark Family (Mother/older child team) Heather Byer, Reaching for the stars Cara Layne, parent Sue Addingon, parent Josephine Kirk, parent March of Dimes Nisonger Center

Other Stakeholder Partners

Warren Lo, Nationwide Children's Hospital Samantha Peterson, Early Childhood Education TBN Insurance representative