Specialized vs Standard Physical Therapy for Cerebral Palsy

(SIT-PT Trial)

Not currently recruiting at 4 trial locations

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Severe visual impairment, Uncontrolled seizures, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effectiveness of two different physical therapy programs for young children with or at high risk of having Cerebral Palsy (CP). One program, START-Play Physical Therapy, focuses on activities that improve sitting, reaching, and problem-solving skills. The other, Usual Care Physical Therapy, is a standard therapy emphasizing movement, orientation, repetition, and exercise. The trial seeks children who are 8-24 months old, can sit with support, and have noticeable delays in gross motor skills. As an unphased trial, this study offers a unique opportunity to explore innovative therapy options that could enhance a child's development.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these physical therapy interventions are safe for children with or at high risk of having Cerebral Palsy?

Research has shown that both START-Play and Usual Care Physical Therapy (now called MORE-PT) are safe for infants. A study on START-Play found it helped infants improve their sitting and reaching skills without causing harm. No serious side effects occurred.

MORE-PT relies on well-known physical therapy methods that are safe and effective. These therapies use natural movements and exercises, making them generally low-risk.

Overall, both therapies are safe for young children and help improve motor skills without causing problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the START-Play intervention for cerebral palsy because it focuses on enhancing both motor skills and cognitive problem-solving simultaneously. Unlike traditional physical therapy, which typically emphasizes repetitive motor exercises, START-Play integrates thinking skills with motor tasks, such as sitting and reaching. This dual focus aims to foster more holistic development in children with cerebral palsy, potentially leading to more significant improvements in their ability to interact with their environment.

What evidence suggests that these physical therapy interventions could be effective for cerebral palsy?

Research shows that START-Play Physical Therapy, one of the interventions in this trial, can assist infants with major motor delays in various ways. Studies have found that this therapy improves reaching, problem-solving, thinking skills, and fine motor abilities more effectively than standard care. Notably, these benefits appear both in the short term and up to 12 months later. The therapy involves activities that combine thinking and movement skills, helping infants learn to sit and reach better. These targeted activities aim to support developmental milestones for young children at risk for or with cerebral palsy. Participants in this trial may receive either the START-Play intervention or the MORE-PT, which follows usual care principles. ^{1 2 3 4 6}

Who Is on the Research Team?

Stacey Dusing

Principal Investigator

University of Southern California Biokinesiology and PT - Motor Development Lab

Are You a Good Fit for This Trial?

This trial is for young children aged 8-24 months with or at high risk of Cerebral Palsy. They must have a gross motor delay, be able to prop sit for a few seconds, focus visually on objects and show some spontaneous arm movement. Children with severe visual impairments, certain congenital anomalies, uncontrolled seizures or progressive disabilities are not eligible.

Inclusion Criteria

My child is between 8-24 months old, considering their adjusted age for prematurity.

Gross motor delay with a Bayley IV gross motor subscale score less than 5.5 (1.5 standard deviation below mean)

I can sit up with support, move my arms, and focus on an object or face for a few seconds.

Exclusion Criteria

I do not have severe health issues that would prevent me from participating in assessments or interventions.

My child does not have a progressive disability, we are not moving soon, no major surgery is planned, and they don't have genetic conditions like intellectual disability or autism.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the START-Play or UCPT intervention for 3 months, focusing on motor skills and problem-solving

12 weeks

24 visits (in-person)

Follow-up

Participants are monitored for changes in sitting behavior, cognitive skills, and motor skills

12 months

What Are the Treatments Tested in This Trial?

Interventions

• START-Play Physical Therapy
• Usual Care Physical Therapy

Trial Overview The study compares two physical therapy methods in toddlers: START-Play focuses on sitting, reaching and problem-solving skills to boost overall development; Usual Care Physical Therapy aims to improve motor skills and prevent impairments related to CP.

How Is the Trial Designed?

Group I: START-Play Intervention Experimental Treatment 1 Intervention

Sitting Together And Reaching to Play is an intervention designed to work on motor-based problem-solving. Thus the activities keep thinking skills at the forefront while also working on advancing motor skills. When initially developed to work with children who were emerging sitters the motor tasks focused on sitting and reaching resulting in the name.

Group II: Movement, Orientation, Repetition, and Exercise (MORE-PT) - Usual Care Physical Therapy Active Control 1 Intervention

This intervention was based on the observations of usual care from a previous study. Key principles included the use of Movement, Orientation, Repetition, and Exercise thus the intervention name was changed to MORE-PT before enrollment started. This reduced bias as the therapists and families were not informed this was usual care which could have biased them.

START-Play Physical Therapy is already approved in United States for the following indications:

Approved in United States as START-Play for:

• Cerebral Palsy
• Motor Delays
• Neuromotor Dysfunction

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Published Research Related to This Trial

A survey of 123 therapists in Canada revealed that physical therapists tend to focus more on 'body functions and structure' in their interventions for children with cerebral palsy, while both occupational and physical therapists emphasize 'activity and participation' but often neglect leisure and community activities.

The study highlights a growing emphasis on modifying the environment in therapy interventions, aligning with current evidence-based practices, but also indicates a need for better integration of participation-focused strategies in therapy for children with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Rehabilitation Practices for Children with Cerebral Palsy: Focus and Gaps. Anaby, D., Korner-Bitensky, N., Steven, E., et al.[2017]

In a study involving 57 youth with cerebral palsy, accelerometers demonstrated excellent inter-instrument reliability (ICC values between 0.94 and 0.99) for measuring physical activity intensity, indicating they are consistent tools for this population.

The accelerometers also showed good concurrent validity (Spearman correlations of 0.70 to 0.85) when compared to indirect calorimetry, confirming their effectiveness in accurately assessing physical activity levels in youth with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability and Validity of Objective Measures of Physical Activity in Youth With Cerebral Palsy Who Are Ambulatory. O'Neil, ME., Fragala-Pinkham, M., Lennon, N., et al.[2019]

A consensus among 12 expert physiotherapists led to the development of a checklist for usual physiotherapy care for ambulant children with cerebral palsy, which can help standardize treatment and measure adherence in clinical trials.

High consensus was achieved on key interventions, including participation in modified sports and fitness activities, and monitoring for children with more severe mobility limitations, indicating these practices are essential for effective physiotherapy care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining usual physiotherapy care in ambulant children with cerebral palsy in the United Kingdom: A mixed methods consensus study. Rapson, R., Latour, JM., Marsden, J., et al.[2022]

Children with spastic cerebral palsy receiving functional physical therapy showed greater improvements in daily functional skills compared to those receiving traditional therapy focused on movement quality, as assessed by the Pediatric Evaluation of Disability Inventory (PEDI).

Both groups improved in basic gross motor abilities measured by the Gross Motor Function Measure (GMFM), but there were no significant differences between the two therapy approaches in this area, indicating that while both therapies are beneficial, functional therapy may be more effective for real-life skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a functional therapy program on motor abilities of children with cerebral palsy. Ketelaar, M., Vermeer, A., Hart, H., et al.[2022]

The study will evaluate a 6-week home-based ride-on-toy navigation training (RNT) program for 15 children aged 3 to 8 years with unilateral cerebral palsy (UCP), aiming to improve upper extremity function when combined with conventional therapy.

The RNT program is expected to be feasible and acceptable, with assessments planned to measure improvements in unimanual and bimanual function, as well as child engagement and motivation during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A protocol for a single-arm interventional study assessing the effects of a home-based joystick-operated ride-on-toy navigation training programme to improve affected upper extremity function and spontaneous use in children with unilateral cerebral palsy (UCP). Shahane, V., Kumavor, P., Morgan, K., et al.[2023]

A new checklist was developed to standardize the description of physiotherapy modalities for children with cerebral palsy, created by a group of specialized physiotherapists and tested across various pediatric units in Italy.

The checklist achieved high inter-rater agreement among expert physiotherapists, making it a reliable tool for improving communication between specialists and families, and enhancing the comparability of research studies in CP rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Core elements of physiotherapy in cerebral palsy children: proposal for a trial checklist. Meghi, P., Rossetti, L., Corrado, C., et al.[2012]

A randomized controlled trial involving 59 children with spastic diplegic cerebral palsy evaluated the effectiveness of individualized home-centered activity-based therapy alongside standard physiotherapy.

While the home-centered therapy was found to be safe and feasible, it did not lead to significant improvements in walking ability over 6 months compared to those receiving only institutional physiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Add-on Home-Centered Activity-Based Therapy vs Conventional Physiotherapy in Improving Walking Ability at 6-Months in Children With Diplegic Cerebral Palsy: A Randomized Controlled Trial. Goswami, JN., Sankhyan, N., Singhi, P.[2021]

In a study of 465 children with cerebral palsy, 66% of the physical therapy interventions provided were evidence-based, indicating a strong adherence to effective treatment practices.

There was significant variation in the types of interventions delivered based on the children's Gross Motor Function Classification System levels, suggesting that therapy may need to be tailored more specifically to individual capabilities for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Describing the Delivery of Evidence-Based Physical Therapy Intervention to Individuals With Cerebral Palsy. Bailes, AF., Greve, K., Long, J., et al.[2023]

A survey of 62 physical therapists and 85 occupational therapists in Quebec revealed that most therapists use standardized assessments for children with cerebral palsy, but there is a significant focus on impairments and primary functions rather than play and leisure activities.

The study highlights a need for improved training and education for therapists regarding cerebral palsy, as well as the establishment of standardized practices to enhance the quality of occupational and physical therapy for affected children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Actual vs. best practices for young children with cerebral palsy: a survey of paediatric occupational therapists and physical therapists in Quebec, Canada. Saleh, MN., Korner-Bitensky, N., Snider, L., et al.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7910024/

START-Play Physical Therapy Intervention Impacts Motor ... START-Play may advance reaching, problem solving, cognitive, and fine motor skills for young infants with significant motor delay over UC-EI in the short term.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04230278

Efficacy of a Physical Therapy Intervention Targeting Sitting ... The purpose of the proposed project is to compare the efficacy of two fully developed physical therapy interventions in 8-24 months olds with or at high risk of ...

3. ies.ed.gov ies.ed.gov/use-work/awards/efficacy-start-play-program-infants-neuromotor-disorders

Efficacy of the START-Play Program for Infants with ... For infants with significant motor delay, significantly positive longer-term effects (up to 12 months) for the START-Play group were found for fine motor and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9291380/

The SIT-PT Trial Protocol: A Dose-Matched Randomized ... This will be the first study, to our knowledge, comparing efficacy of early physical therapy with dose-matched interventions and well-defined key principles.

5. academic.oup.com academic.oup.com/ptj/article/98/6/494/4867982

Protocol for a Multisite Randomized Controlled Efficacy Trial ... The aim of this project is to evaluate the efficacy of Sitting Together And Reaching To Play (START-Play), an intervention designed to target sitting, reaching, ...

6. ies.ed.gov ies.ed.gov/ncee/wwc/Study/90301

Study: 90301 - Institute of Education Sciences START-Play Physical Therapy Intervention Impacts Motor and Cognitive Outcomes in Infants with Neuromotor Disorders: A Multisite Randomized Clinical Trial.