Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy (SIT-PT)
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| ClinicalTrials.gov Identifier: NCT04230278 |
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Recruitment Status :
Recruiting
First Posted : January 18, 2020
Last Update Posted : April 28, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cerebral Palsy | Behavioral: START-Play Physical Therapy Behavioral: Usual Care Physical Therapy | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Evaluation of the Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy |
| Actual Study Start Date : | March 1, 2021 |
| Estimated Primary Completion Date : | July 2025 |
| Estimated Study Completion Date : | July 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: START-Play 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.
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Behavioral: START-Play Physical Therapy
Physical Therapy focused on movement and cognitive skills at the same time |
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Active Comparator: Movement, Orientation, Repetition, and Exercise (MORE-PT) - Usual Care Physical Therapy
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.
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Behavioral: Usual Care Physical Therapy
Physical Therapy focused on movement and reducing impairments |
- 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)
- Change in gross motor skills [ Time Frame: Baseline to the end of the intervention, up to 12 months ]Gross motor skills will be assessed using the gross motor subtest of the Bayley Scales of Infant and Toddler Development, Fourth edition (Bayley-IV).
- Change in fine motor skills [ Time Frame: Baseline to the end of the intervention, up to 12 months ]Fine motor skills will be assessed using the Fine motor subtest of the Bayley Scales of Infant and Toddler Development, Fourth edition (Bayley-IV).
- Change in Cognitive skills [ Time Frame: Baseline to the end of the intervention, up to 12 months ]Cognitive skills will be assessed using the cognitive subtest of the Bayley Scales of Infant and Toddler Development, Fourth edition (Bayley-IV).
- Change in Language [ Time Frame: Baseline to the end of the intervention, up to 12 months ]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).
- Assessment of Problem Solving in Play [ Time Frame: Baseline to the end of the intervention, up to 12 months ]
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
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| Ages Eligible for Study: | 8 Months to 24 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230278
| United States, California | |
| University of Southern California | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Stacey Dusing 323-442-1022 stacey.dusing@pt.usc.edu | |
| United States, Nebraska | |
| University of Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68198 | |
| Contact: Sandra Willett, PhD, PT 402-559-6415 swillett@unmc.edu | |
| United States, Washington | |
| University of Washington | Recruiting |
| Seattle, Washington, United States, 356490 | |
| Contact: Lin-Ya Hsu, PhD 206-669-2492 linyahsu@uw.edu | |
| Responsible Party: | Stacey Dusing, Associate Professor, University of Southern California |
| ClinicalTrials.gov Identifier: | NCT04230278 |
| Other Study ID Numbers: |
HM20016342 |
| First Posted: | January 18, 2020 Key Record Dates |
| Last Update Posted: | April 28, 2022 |
| Last Verified: | April 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cerebral Palsy Nervous System Diseases Brain Damage, Chronic Brain Diseases Central Nervous System Diseases |