Cerebral PalsySIT-PTNCT04230278
Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy
A study testing START-Play Physical Therapy in people with Cerebral Palsy, run by University of Southern California at 4 sites in United States.
Trial summary
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 having Cerebral Palsy (CP). Read more about this study
- Who is it for?
- Ages 8 to 24 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- START-Play Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2021to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Dx or clinical signs of cerebral palsy (CP) previously described
- Between 8-24 months of age (corrected for prematurity as applicable) at study entry
- Able to prop sit for 3 seconds, maintain the head at least to the level of neutral alignment with the trunk supported at the axilla, exhibit some spontaneous movement of the arms and visually focus on a toy or person's face for at least 3 seconds in any position.
- Gross motor delay with a Bayley IV gross motor subscale score less than 5.5 (1.5 standard deviation below mean)
Who cannot join
- Medical complications that severely limit assessments/intervention participation such as severe visual impairment, congenital/orthopedic anomalies that limit sitting or reaching, or uncontrolled seizures.
- A child will be excluded if the parents report any of following: 1) disability of a progressive nature such as muscular dystrophy or leukodystrophy; 2) family plans to move out of the local area within one year from the start of the study; 3) major surgery planned that might affect physical performance. 4) genetic conditions that have a similar presentation to intellectual disability or autism.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Southern California
Los Angeles, California, 90033
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Virginia Commonwealth University
Richmond, Virginia, 23298
University of Washington
Seattle, Washington, 356490
About this study
Official title: Evaluation of the Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy
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 having Cerebral Palsy (CP). Sitting Together And Reaching To Play (START-Play) targets sitting, reaching and motor-based problem solving in infancy to improve global development. Usual Care Physical Therapy (UCPT) focuses on advancing motor skills and preventing impairments.
Read the detailed description
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 having Cerebral Palsy (CP). Sitting Together And Reaching To Play (START-Play) targets sitting, reaching and motor-based problem solving in infancy to improve global development. Usual Care Physical Therapy (UCPT) focuses on advancing motor skills and preventing impairments. The project builds on a nearly complete clinical trial evaluating the efficacy of the START-Play intervention compared to a non-dose matched comparison group. The proposed study directly addressed the need for a dose-matched clinical trial to consider the impact of dose of intervention on efficacy. A direct comparison of START-Play with the dose matched (24 visits in 3 months) UCPT provided in the same environment (homes) and provided by licensed physical therapists will allow for a direct comparison of the efficacy of interventions based on two different set of key principles.
START-Play is based on developmental and basic science, motor learning, and neuroplasticity, in addition to our extensive preliminary efficacy data. START-Play has been fully described with a protocol manual, training documents, and fidelity measures. The UCPT intervention is based on videotaped session of the comparison group community based intervention sessions and parent report for the ongoing clinical trial. A fidelity measure used the previous research quantifies differences in the focus of these interventions and will be used to maintain adherence to both intervention groups. Three sites in different regions of the United States will recruit from local intervention and medical centers for a total of 150 infants with or at high risk of having cerebral palsy between ages 4-24 months of age, when they show readiness skills for early sitting and reaching. Risk for CP will be based on the early detection guidelines and all outcome measures are included in the NIH supported Common Data Elements for Cerebral Palsy. Each infant will be randomized into a group and will receive the START-Play or the UCPT intervention for 3 months, with follow up extending for 12 months from baseline.
The primary objectives examine change over time in sitting gross motor and cognitive development.
Differences in outcomes between the two intervention groups will be examined. In addition, we will begin to identify predictors of response to developmental motor interventions by evaluating the relationship between intervention outcomes and 1) infant and family characteristics, 2) presence of white matter, cerebellar, basal ganglion, or gray matter injury.
- Conditions
- Cerebral Palsy
- Being tested
- START-Play Physical Therapy, Usual Care Physical Therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
START-Play Physical TherapyBehavioural
Physical Therapy focused on movement and cognitive skills at the same time
Usual Care Physical TherapyBehavioural
Physical Therapy focused on movement and reducing impairments
| Study group | Role | What they receive |
|---|---|---|
| START-Play Intervention | Experimental | 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. Receives: Behavioral: START-Play Physical Therapy |
| Movement, Orientation, Repetition, and Exercise (MORE-PT) - Usual Care Physical Therapy | Active comparator | 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. Receives: Behavioral: Usual Care Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sitting behavior
Sitting will be assessed using the sitting scale of the Gross Motor Function Measure (GMFM-88)
Measured: Baseline to the end of the intervention, up to 12 months
Secondary outcomes (4)
Change in gross motor skills
Gross motor skills will be assessed using the gross motor subtest of the Bayley Scales of Infant and Toddler Development, Fourth edition (Bayley-IV).
Measured: Baseline to the end of the intervention, up to 12 months
Change in fine motor skills
Fine motor skills will be assessed using the Fine motor subtest of the Bayley Scales of Infant and Toddler Development, Fourth edition (Bayley-IV).
Measured: Baseline to the end of the intervention, up to 12 months
Change in Cognitive skills
Cognitive skills will be assessed using the cognitive subtest of the Bayley Scales of Infant and Toddler Development, Fourth edition (Bayley-IV).
Measured: Baseline to the end of the intervention, up to 12 months
Change in Language
Expressive and Receptive Language skills will be assessed using the language subtests of the Bayley Scales of Infant and Toddler Development, fourth edition (Bayley-IV).
Measured: Baseline to the end of the intervention, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Mar 2021
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacey Dusing, University of Southern California
- Investigators
- Stacey Dusing, Principal investigator, University of Southern California Biokinesiology and PT - Motor Development Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230278
- Sponsor's protocol ID
- HM20016342
- Acronym
- SIT-PT
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2020
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kretch KS, Dusing SC, Harbourne RT, Hsu LY, Sargent BA, Willett SL. Early Mobility and Crawling: Beliefs and Practices of Pediatric Physical Therapists in the United States. Pediatr Phys Ther. 2024 Jan 1;36(1):9-17. doi: 10.1097/PEP.0000000000001063.
PubMed 38127897Kretch KS, Koziol NA, Marcinowski EC, Hsu LY, Harbourne RT, Lobo MA, McCoy SW, Willett SL, Dusing SC. Sitting Capacity and Performance in Infants with Typical Development and Infants with Motor Delay. Phys Occup Ther Pediatr. 2024;44(2):164-179. doi: 10.1080/01942638.2023.2241537. Epub 2023 Aug 7.
PubMed 37550959Fiss AL, Hakstad RB, Looper J, Pereira SA, Sargent B, Silveira J, Willett S, Dusing SC. Embedding Play to Enrich Physical Therapy. Behav Sci (Basel). 2023 May 24;13(6):440. doi: 10.3390/bs13060440.
PubMed 37366692Dusing SC, Harbourne RT, Hsu LY, Koziol NA, Kretch K, Sargent B, Jensen-Willett S, McCoy SW, Vanderbilt DL. The SIT-PT Trial Protocol: A Dose-Matched Randomized Clinical Trial Comparing 2 Physical Therapist Interventions for Infants and Toddlers With Cerebral Palsy. Phys Ther. 2022 Jul 4;102(7):pzac039. doi: 10.1093/ptj/pzac039.
PubMed 35421222Dusing SC, Harbourne RT, Lobo MA, Westcott-McCoy S, Bovaird JA, Kane AE, Syed G, Marcinowski EC, Koziol NA, Brown SE. A Physical Therapy Intervention to Advance Cognitive and Motor Skills: A Single Subject Study of a Young Child With Cerebral Palsy. Pediatr Phys Ther. 2019 Oct;31(4):347-352. doi: 10.1097/PEP.0000000000000635.
PubMed 31568380
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04230278
- Acronym / sponsor ID
- SIT-PT / HM20016342
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 having Cerebral Palsy (CP). Sitting Together And Reaching To Play (START-Play) targets sitting, reaching and motor-based problem solving in infancy to improve global development. Usual Care Physical Therapy (UCPT) focuses on advancing motor skills and preventing impairments.
Detailed description
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 having Cerebral Palsy (CP). Sitting Together And Reaching To Play (START-Play) targets sitting, reaching and motor-based problem solving in infancy to improve global development. Usual Care Physical Therapy (UCPT) focuses on advancing motor skills and preventing impairments. The project builds on a nearly complete clinical trial evaluating the efficacy of the START-Play intervention compared to a non-dose matched comparison group. The proposed study directly addressed the need for a dose-matched clinical trial to consider the impact of dose of intervention on efficacy. A direct comparison of START-Play with the dose matched (24 visits in 3 months) UCPT provided in the same environment (homes) and provided by licensed physical therapists will allow for a direct comparison of the efficacy of interventions based on two different set of key principles.
START-Play is based on developmental and basic science, motor learning, and neuroplasticity, in addition to our extensive preliminary efficacy data. START-Play has been fully described with a protocol manual, training documents, and fidelity measures. The UCPT intervention is based on videotaped session of the comparison group community based intervention sessions and parent report for the ongoing clinical trial. A fidelity measure used the previous research quantifies differences in the focus of these interventions and will be used to maintain adherence to both intervention groups. Three sites in different regions of the United States will recruit from local intervention and medical centers for a total of 150 infants with or at high risk of having cerebral palsy between ages 4-24 months of age, when they show readiness skills for early sitting and reaching. Risk for CP will be based on the early detection guidelines and all outcome measures are included in the NIH supported Common Data Elements for Cerebral Palsy. Each infant will be randomized into a group and will receive the START-Play or the UCPT intervention for 3 months, with follow up extending for 12 months from baseline.
The primary objectives examine change over time in sitting gross motor and cognitive development.
Differences in outcomes between the two intervention groups will be examined. In addition, we will begin to identify predictors of response to developmental motor interventions by evaluating the relationship between intervention outcomes and 1) infant and family characteristics, 2) presence of white matter, cerebellar, basal ganglion, or gray matter injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| START-Play Intervention | Experimental | Behavioral: START-Play Physical TherapySitting 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. |
| Movement, Orientation, Repetition, and Exercise (MORE-PT) - Usual Care Physical Therapy | Active comparator | Behavioral: Usual Care Physical TherapyThis 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. |
Who may qualify
- Ages
- 8 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Dx or clinical signs of cerebral palsy (CP) previously described
- Between 8-24 months of age (corrected for prematurity as applicable) at study entry
- Able to prop sit for 3 seconds, maintain the head at least to the level of neutral alignment with the trunk supported at the axilla, exhibit some spontaneous movement of the arms and visually focus on a toy or person's face for at least 3 seconds in any position.
- Gross motor delay with a Bayley IV gross motor subscale score less than 5.5 (1.5 standard deviation below mean)
Key exclusion criteria (2 listed)
- Medical complications that severely limit assessments/intervention participation such as severe visual impairment, congenital/orthopedic anomalies that limit sitting or reaching, or uncontrolled seizures.
- A child will be excluded if the parents report any of following: 1) disability of a progressive nature such as muscular dystrophy or leukodystrophy; 2) family plans to move out of the local area within one year from the start of the study; 3) major surgery planned that might affect physical performance. 4) genetic conditions that have a similar presentation to intellectual disability or autism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| START-Play Physical TherapyPhysical Therapy focused on movement and cognitive skills at the same time | Behavioural | START-Play Intervention |
| Usual Care Physical TherapyPhysical Therapy focused on movement and reducing impairments | Behavioural | Movement, Orientation, Repetition, and Exercise (MORE-PT) - Usual Care Physical Therapy |
Primary outcome
Change in sitting behavior
Time frame: Baseline to the end of the intervention, up to 12 months
Sitting will be assessed using the sitting scale of the Gross Motor Function Measure (GMFM-88)
4 secondary outcomes
Change in gross motor skills
Time frame: Baseline to the end of the intervention, up to 12 months
Change in fine motor skills
Time frame: Baseline to the end of the intervention, up to 12 months
Change in Cognitive skills
Time frame: Baseline to the end of the intervention, up to 12 months
Change in Language
Time frame: Baseline to the end of the intervention, up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 38127897Kretch KS, Dusing SC, Harbourne RT, Hsu LY, Sargent BA, Willett SL. Early Mobility and Crawling: Beliefs and Practices of Pediatric Physical Therapists in the United States. Pediatr Phys Ther. 2024 Jan 1;36(1):9-17. doi: 10.1097/PEP.0000000000001063.
- Background: PubMed 37550959Kretch KS, Koziol NA, Marcinowski EC, Hsu LY, Harbourne RT, Lobo MA, McCoy SW, Willett SL, Dusing SC. Sitting Capacity and Performance in Infants with Typical Development and Infants with Motor Delay. Phys Occup Ther Pediatr. 2024;44(2):164-179. doi: 10.1080/01942638.2023.2241537. Epub 2023 Aug 7.
- Background: PubMed 37366692Fiss AL, Hakstad RB, Looper J, Pereira SA, Sargent B, Silveira J, Willett S, Dusing SC. Embedding Play to Enrich Physical Therapy. Behav Sci (Basel). 2023 May 24;13(6):440. doi: 10.3390/bs13060440.
- Background: PubMed 35421222Dusing SC, Harbourne RT, Hsu LY, Koziol NA, Kretch K, Sargent B, Jensen-Willett S, McCoy SW, Vanderbilt DL. The SIT-PT Trial Protocol: A Dose-Matched Randomized Clinical Trial Comparing 2 Physical Therapist Interventions for Infants and Toddlers With Cerebral Palsy. Phys Ther. 2022 Jul 4;102(7):pzac039. doi: 10.1093/ptj/pzac039.
- Background: PubMed 31568380Dusing SC, Harbourne RT, Lobo MA, Westcott-McCoy S, Bovaird JA, Kane AE, Syed G, Marcinowski EC, Koziol NA, Brown SE. A Physical Therapy Intervention to Advance Cognitive and Motor Skills: A Single Subject Study of a Young Child With Cerebral Palsy. Pediatr Phys Ther. 2019 Oct;31(4):347-352. doi: 10.1097/PEP.0000000000000635.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey Dusing principal investigator
University of Southern California Biokinesiology and PT - Motor Development Lab
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing START-Play Physical Therapy in people with Cerebral Palsy, run by University of Southern California at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sitting behavior (time frame: Baseline to the end of the intervention, up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04230278, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.