Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

— SIT-PT  

Official title:

Evaluation of the Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04230278
• Other study ID #: HM20016342
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Months to 24 Months

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Behavioral:
• START-Play Physical Therapy
Physical Therapy focused on movement and cognitive skills at the same time
• Usual Care Physical Therapy
Physical Therapy focused on movement and reducing impairments

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (5)

Dusing 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. — View Citation

Dusing 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. — View Citation

Fiss 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. — View Citation

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. — View Citation

Kretch 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of Problem Solving in Play	6 minute assessment of play based problem solving skills using a standardized toy set. The frequency of 4 key behaviors (look, simple explore, complex explore, function, and solution are coded. (Phys Occup Ther Pediatr; . 2021;41(4):390-409. doi: 10.1080/0194	Baseline to the end of the intervention, up to 12 months
Primary	Change in sitting behavior	Sitting will be assessed using the sitting scale of the Gross Motor Function Measure (GMFM-88)	Baseline to the end of the intervention, up to 12 months
Secondary	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).	Baseline to the end of the intervention, up to 12 months
Secondary	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).	Baseline to the end of the intervention, up to 12 months
Secondary	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).	Baseline to the end of the intervention, up to 12 months
Secondary	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).	Baseline to the end of the intervention, up to 12 months

External Links

•   Link to the pre-publication protocol paper