Cerebral PalsySTART-PlayNCT02593825
Efficacy of the START-Play Program for Infants With Neuromotor Disorders
A study testing START-Play intervention and Business as usual in people with Cerebral Palsy and Developmental Delay, run by Duquesne University at 1 site in United States.
Trial summary
The purpose of this project is to evaluate the efficacy of Sitting Together And Reaching To Play (START-Play), an intervention designed to target sitting, reaching, and motor-based problem solving to improve development and readiness to learn in infants with motor delays or dysfunction. Read more about this study
- Who is it for?
- Ages 7 to 16 months
- Conditions the study is for
- Cerebral Palsy, Developmental Delay, Infant Development
- What is being tested?
- START-Play intervention and Business as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 12 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 16 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Infants enter study between 7-16 months of age, when they are able to prop sit for 3 seconds and maintain their head at least to the level of neutral alignment with their trunk.
- Gross motor delay as reflected in the Bayley III motor subtest >1.0 Standard Deviation below the mean.
- Neuromotor disorder such as cerebral palsy (CP), or at risk for CP because of extreme prematurity or brain damage that occurred at or around birth, or infants with motor delay of an unspecified origin (no clear diagnosis, but delay as above) -• Minimal movement requirements/Indicators of readiness for change: Sits with support of arms for 3 seconds after being placed. Exhibits at least some spontaneous movement of arms.
Who cannot join
- • Medical complications that severely limit participation in assessments and intervention such as severe visual and congenital/genetic anomalies, uncontrolled seizure disorder.
- Diagnosis other than an unchanging neuromotor disorder (examples: autism, Down syndrome, spinal cord injury, acquired head injury, muscle disorder).
- A child will be excluded if the parents report any of following: 1) if the child has a disability of a progressive nature such as muscular dystrophy; 2) if the child's family plans to move out of the local area within one year from the start of the study; 3) if the child has major surgery planned that might affect physical performance.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this project is to evaluate the efficacy of Sitting Together And Reaching To Play (START-Play), an intervention designed to target sitting, reaching, and motor-based problem solving to improve development and readiness to learn in infants with motor delays or dysfunction. There is limited research examining the efficacy of early physical intervention on infants with neuromotor dysfunction. In addition, most early motor interventions have not been directly linked to learning, despite the research demonstrating an association between motor activity and cognitive skills. START-Play specifically targets motor skills that lead to greater physical exploration, which has been associated with improved problem solving and global development. A randomized controlled trial of START-Play will be conducted across four states to investigate the impact of the intervention on changes over time in sitting and reaching, subsequent changes in global cognitive development, and the mediating influences of motor skill changes and problem solving. The research team will conduct a randomized controlled trial to evaluate the impact of START-Play on motor development, motor problem solving, global development including cognitive problem solving of infants with neuromotor delay and dysfunction. Infants will experience either the intervention or services as usual for 3 months, with following testing at three time points up until 9 months post intervention. The researchers will determine whether the intervention leads to improved sitting and reaching, which leads to improved motor-based problem solving, which leads to improved global development and problem solving.
Read the detailed description
Setting: The research will take place in the homes of infants and their families in Pennsylvania, Delaware, Washington, and Virginia.
Sample: There will be approximately 140 infants with neuromotor disorders completing participation in this study, beginning at the age the age of 7 to 16 months, as well as their families and interventionists. Infants will have gross motor delays but be able to sit propped up for at least 3 seconds when they are recruited for participation.
Intervention: Sitting Together And Reaching To Play (START-Play) is an intervention for infants with motor dysfunction or delay in which physical therapists visit the child's home to target work on siting, reaching, and problem solving. The therapist visits the home twice weekly for 3 months. During these visits, therapists and families work together to provide intensive, individualized, daily activities to advance reaching and sitting through small increments of challenge and support for these skills, which then become the building blocks for motor-based problem solving. More specifically, the intervention focuses on self-initiated, goal-directed movements to build orientation and attention to objects, while learning basic relationships of cause and effect. Infants and families in the intervention group will receive this intervention in addition to their usual early intervention services.
Research Design and Methods: This study will use a randomized controlled trial in which infants and their families are randomly assigned to the intervention group (START-Play in addition to usual services) or control group (usual early intervention services), stratified by severity of neuromotor disorder. There will be six measurement sessions during the 12-week intervention period, following by assessments during 1-, 3-, and 9-month follow-up visits. The study aims to determine the efficacy of the intervention on sitting and reaching (proximal outcomes) and motor-based problem solving skills (longer-term proximal outcome), which is hypothesized to serve as mediators to the more distal outcomes of global cognitive development and readiness to learn. The investigators will also explore fidelity of implementation to identify conditions that support fidelity and outcomes, as well as identify other moderating factors related to the child (severity of disorder, health, age, cognitive skill at entry), family (socioeconomic status, home environment), or services (fidelity of implementation, other services provided to child) to explore change over time.
Control Condition: Infants and their families in the control condition will continue to receive their regular Part C early intervention services.
Key Measures: Primary outcome measures in the study include the Gross Motor Function Measure and an observational measure of toy contacts for sitting and reaching, and the Individual and Growth Development Indicators (Early Problem Solving Indicator) and Bayley Scales of Infant and Toddler Development -Third Edition for problem solving and global development. Secondary measures include additional measures of postural control and reaching, child and family characteristics, and fidelity of implementation (logs and checklist).
Data Analytic Strategy: The investigators will use linear mixed modeling (LMM) to determine the efficacy of the intervention on child outcomes. Parallel process growth modeling within a structural equation modeling framework will be used to examine whether improvements in sitting and reaching are mediators leading to improvements in problem solving, which is then a mediator leading to long-term global cognitive development. LMM will also be used to examine moderating variables, as well as secondary motor outcomes.
- Conditions
- Cerebral Palsy, Developmental Delay, Infant Development
- Being tested
- START-Play intervention, Business as usual
- Medical subject headings
- Cerebral Palsy, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
START-Play interventionBehavioural
Also called Perceptual motor early intervention for infants
The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill.
Business as usualBehavioural
Also called Early intervention, physical therapy
May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training
| Study group | Role | What they receive |
|---|---|---|
| START-Play intervention | Experimental | Intervention incorporating cognitive factors and focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months. Receives: Behavioral: START-Play intervention |
| Business as Usual | Active comparator | Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically. Receives: Behavioral: Business as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley Scales of Infant Development III
Bayley Scales of Infant Development III, cognitive scale; raw scores used to reflect change over time and absolute growth (rather than standard scores) Range: Minimum =20 points; Maximum=60 Higher score = better outcome
Measured: Baseline, at end of 3 month intervention, and at 12 months post-baseline
Secondary outcomes (6)
Change in Modified Parent Child Interaction-Dyadic Mini Code
Play and interaction of parent and child, coding of behavior frequency and type of interaction; coded as a total percentage of time the parent provided cognitive opportunities
Measured: Baseline, at end of 3 month intervention, and at 6 and 12 months after baseline
Change in Frequency (Number) of Toy Contacts
behavioral coding of play and hand use, coded from videotape; Coding software used to time contacts during standard reaching task during 5 minute reaching at shoulder level and below.
Measured: Baseline, at end of 3 month intervention, and at 12 months after baseline
Change in Duration (Time) of Toy Contacts
coding number seconds of videotaped hand use during play; timing coded in a video coding software for behavioral analysis Higher score=better
Measured: Baseline, at end of 3 month intervention, and at 12 months after baseline
Change in Gross Motor Function Measure, Sitting Subscale
Gross motor skills in the sitting subsection of the Gross Motor Function Measure (GMFM) Minimum value=4 Maximum value=60 Higher scores=better outcome
Measured: Baseline, at end of 3 month intervention, and at 12 months after baseline
Change in Early Problem Solving Indicator (EPSI)
Infant growth and development indicator of problem solving skills, adapted for children with motor deficits Modified to Assessment of Problem-Solving in Play (APSP) Minimum=30 Maximum=120 Higher=better outcome
Measured: Baseline, at end of 3 month intervention, and at 6 and 12 months after baseline
Change in Reaching (Change in Looking and Hand Contact of Toy)
Looking while contacting toy, frequency of either unimanual or bimanual contact while looking at toy
Measured: Baseline, at end of 3 month intervention, and at 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startJan 2016
- Primary completion1 Jun 2020
- Study completion12 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware, Virginia Commonwealth University, University of Washington, University of Nebraska Lincoln
- Responsible party
- Sponsor
- Investigators
- Regina T Harbourne, PhD, Principal investigator, Duquesne UniversitySarah W McCoy, PhD, Principal investigator, University of WashingtonMichele A. Lobo, PhD, Principal investigator, University of DelawareStacey C. Dusing, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593825
- Sponsor's protocol ID
- R324A150103
- Acronym
- START-Play
- Status last verified
- Aug 2023
- First submitted
- 29 Oct 2015
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Harbourne RT, Dusing SC, Lobo MA, Westcott-McCoy S, Bovaird J, Sheridan S, Galloway JC, Chang HJ, Hsu LY, Koziol N, Marcinowski EC, Babik I. Sitting Together And Reaching To Play (START-Play): Protocol for a Multisite Randomized Controlled Efficacy Trial on Intervention for Infants With Neuromotor Disorders. Phys Ther. 2018 Jun 1;98(6):494-502. doi: 10.1093/ptj/pzy033.
PubMed 29767802Molinini R, Stuyvenburg C, Koziol NA, Harbourne RT, Lobo MA, Willett SL, Bovaird JA, Marcinowski E, Price SK, Shall M, Chu VW, Dusing SC. Developmental Trajectories of Emotional Availability Differ Between Dyads With Children With and Without Motor Delay. Infancy. 2025 May-Jun;30(3):e70027. doi: 10.1111/infa.70027.
PubMed 40537937Cunha AB, Babik I, Choi D, Koziol N, Harbourne RT, Dusing SC, McCoy SW, Willett SL, Bovaird JA, Lobo MA. The impact of severity of motor delay, timing of task mastery, and START-play intervention on the development of means-end problem solving in young children. Braz J Phys Ther. 2024 Jan-Feb;28(1):100590. doi: 10.1016/j.bjpt.2024.100590. Epub 2024 Feb 9.
PubMed 38359542Koziol NA, Butera CD, Kretch KS, Harbourne RT, Lobo MA, McCoy SW, Hsu LY, Willett SL, Kane AE, Bovaird JA, Dusing SC. Effect of the START-Play Physical Therapy Intervention on Cognitive Skills Depends on Caregiver-Provided Learning Opportunities. Phys Occup Ther Pediatr. 2022;42(5):510-525. doi: 10.1080/01942638.2022.2054301. Epub 2022 Mar 29.
PubMed 35350970Harbourne RT, Dusing SC, Lobo MA, McCoy SW, Koziol NA, Hsu LY, Willett S, Marcinowski EC, Babik I, Cunha AB, An M, Chang HJ, Bovaird JA, Sheridan SM. START-Play Physical Therapy Intervention Impacts Motor and Cognitive Outcomes in Infants With Neuromotor Disorders: A Multisite Randomized Clinical Trial. Phys Ther. 2021 Feb 4;101(2):pzaa232. doi: 10.1093/ptj/pzaa232.
PubMed 33382406Marcinowski EC, Tripathi T, Hsu LY, Westcott McCoy S, Dusing SC. Sitting skill and the emergence of arms-free sitting affects the frequency of object looking and exploration. Dev Psychobiol. 2019 Nov;61(7):1035-1047. doi: 10.1002/dev.21854. Epub 2019 Apr 22.
PubMed 31012090
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the START-Play Program for Infants With Neuromotor Disorders
- ClinicalTrials.gov ID
- NCT02593825
- Acronym / sponsor ID
- START-Play / R324A150103
- Conditions
- Cerebral Palsy, Developmental Delay, Infant Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Duquesne UniversityUniversity, hospital or other
- Collaborators
- University of Delaware, Virginia Commonwealth University, University of Washington, University of Nebraska Lincoln
- Study start
- Jan 2016 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 12 Jun 2022 (actual)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Posted 1 Sep 2020
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 this project is to evaluate the efficacy of Sitting Together And Reaching To Play (START-Play), an intervention designed to target sitting, reaching, and motor-based problem solving to improve development and readiness to learn in infants with motor delays or dysfunction. There is limited research examining the efficacy of early physical intervention on infants with neuromotor dysfunction. In addition, most early motor interventions have not been directly linked to learning, despite the research demonstrating an association between motor activity and cognitive skills. START-Play specifically targets motor skills that lead to greater physical exploration, which has been associated with improved problem solving and global development. A randomized controlled trial of START-Play will be conducted across four states to investigate the impact of the intervention on changes over time in sitting and reaching, subsequent changes in global cognitive development, and the mediating influences of motor skill changes and problem solving. The research team will conduct a randomized controlled trial to evaluate the impact of START-Play on motor development, motor problem solving, global development including cognitive problem solving of infants with neuromotor delay and dysfunction. Infants will experience either the intervention or services as usual for 3 months, with following testing at three time points up until 9 months post intervention. The researchers will determine whether the intervention leads to improved sitting and reaching, which leads to improved motor-based problem solving, which leads to improved global development and problem solving.
Detailed description
Setting: The research will take place in the homes of infants and their families in Pennsylvania, Delaware, Washington, and Virginia.
Sample: There will be approximately 140 infants with neuromotor disorders completing participation in this study, beginning at the age the age of 7 to 16 months, as well as their families and interventionists. Infants will have gross motor delays but be able to sit propped up for at least 3 seconds when they are recruited for participation.
Intervention: Sitting Together And Reaching To Play (START-Play) is an intervention for infants with motor dysfunction or delay in which physical therapists visit the child's home to target work on siting, reaching, and problem solving. The therapist visits the home twice weekly for 3 months. During these visits, therapists and families work together to provide intensive, individualized, daily activities to advance reaching and sitting through small increments of challenge and support for these skills, which then become the building blocks for motor-based problem solving. More specifically, the intervention focuses on self-initiated, goal-directed movements to build orientation and attention to objects, while learning basic relationships of cause and effect. Infants and families in the intervention group will receive this intervention in addition to their usual early intervention services.
Research Design and Methods: This study will use a randomized controlled trial in which infants and their families are randomly assigned to the intervention group (START-Play in addition to usual services) or control group (usual early intervention services), stratified by severity of neuromotor disorder. There will be six measurement sessions during the 12-week intervention period, following by assessments during 1-, 3-, and 9-month follow-up visits. The study aims to determine the efficacy of the intervention on sitting and reaching (proximal outcomes) and motor-based problem solving skills (longer-term proximal outcome), which is hypothesized to serve as mediators to the more distal outcomes of global cognitive development and readiness to learn. The investigators will also explore fidelity of implementation to identify conditions that support fidelity and outcomes, as well as identify other moderating factors related to the child (severity of disorder, health, age, cognitive skill at entry), family (socioeconomic status, home environment), or services (fidelity of implementation, other services provided to child) to explore change over time.
Control Condition: Infants and their families in the control condition will continue to receive their regular Part C early intervention services.
Key Measures: Primary outcome measures in the study include the Gross Motor Function Measure and an observational measure of toy contacts for sitting and reaching, and the Individual and Growth Development Indicators (Early Problem Solving Indicator) and Bayley Scales of Infant and Toddler Development -Third Edition for problem solving and global development. Secondary measures include additional measures of postural control and reaching, child and family characteristics, and fidelity of implementation (logs and checklist).
Data Analytic Strategy: The investigators will use linear mixed modeling (LMM) to determine the efficacy of the intervention on child outcomes. Parallel process growth modeling within a structural equation modeling framework will be used to examine whether improvements in sitting and reaching are mediators leading to improvements in problem solving, which is then a mediator leading to long-term global cognitive development. LMM will also be used to examine moderating variables, as well as secondary motor outcomes.
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 interventionIntervention incorporating cognitive factors and focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months. |
| Business as Usual | Active comparator | Behavioral: Business as usualEarly motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically. |
Who may qualify
- Ages
- 7 to 16 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- • Infants enter study between 7-16 months of age, when they are able to prop sit for 3 seconds and maintain their head at least to the level of neutral alignment with their trunk.
Key exclusion criteria (3 listed)
- • Medical complications that severely limit participation in assessments and intervention such as severe visual and congenital/genetic anomalies, uncontrolled seizure disorder.
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 interventionAlso: Perceptual motor early intervention for infantsThe START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill. | Behavioural | START-Play intervention |
| Business as usualAlso: Early intervention, physical therapyMay include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training | Behavioural | Business as Usual |
Primary outcome
Bayley Scales of Infant Development III
Time frame: Baseline, at end of 3 month intervention, and at 12 months post-baseline
Bayley Scales of Infant Development III, cognitive scale; raw scores used to reflect change over time and absolute growth (rather than standard scores) Range: Minimum =20 points; Maximum=60 Higher score = better outcome
6 secondary outcomes
Change in Modified Parent Child Interaction-Dyadic Mini Code
Time frame: Baseline, at end of 3 month intervention, and at 6 and 12 months after baseline
Change in Frequency (Number) of Toy Contacts
Time frame: Baseline, at end of 3 month intervention, and at 12 months after baseline
Change in Duration (Time) of Toy Contacts
Time frame: Baseline, at end of 3 month intervention, and at 12 months after baseline
Change in Gross Motor Function Measure, Sitting Subscale
Time frame: Baseline, at end of 3 month intervention, and at 12 months after baseline
Change in Early Problem Solving Indicator (EPSI)
Time frame: Baseline, at end of 3 month intervention, and at 6 and 12 months after baseline
Change in Reaching (Change in Looking and Hand Contact of Toy)
Time frame: Baseline, at end of 3 month intervention, and at 12 months after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29767802Harbourne RT, Dusing SC, Lobo MA, Westcott-McCoy S, Bovaird J, Sheridan S, Galloway JC, Chang HJ, Hsu LY, Koziol N, Marcinowski EC, Babik I. Sitting Together And Reaching To Play (START-Play): Protocol for a Multisite Randomized Controlled Efficacy Trial on Intervention for Infants With Neuromotor Disorders. Phys Ther. 2018 Jun 1;98(6):494-502. doi: 10.1093/ptj/pzy033.
- Derived from this study: PubMed 40537937Molinini R, Stuyvenburg C, Koziol NA, Harbourne RT, Lobo MA, Willett SL, Bovaird JA, Marcinowski E, Price SK, Shall M, Chu VW, Dusing SC. Developmental Trajectories of Emotional Availability Differ Between Dyads With Children With and Without Motor Delay. Infancy. 2025 May-Jun;30(3):e70027. doi: 10.1111/infa.70027.
- Derived from this study: PubMed 38359542Cunha AB, Babik I, Choi D, Koziol N, Harbourne RT, Dusing SC, McCoy SW, Willett SL, Bovaird JA, Lobo MA. The impact of severity of motor delay, timing of task mastery, and START-play intervention on the development of means-end problem solving in young children. Braz J Phys Ther. 2024 Jan-Feb;28(1):100590. doi: 10.1016/j.bjpt.2024.100590. Epub 2024 Feb 9.
- Derived from this study: PubMed 35350970Koziol NA, Butera CD, Kretch KS, Harbourne RT, Lobo MA, McCoy SW, Hsu LY, Willett SL, Kane AE, Bovaird JA, Dusing SC. Effect of the START-Play Physical Therapy Intervention on Cognitive Skills Depends on Caregiver-Provided Learning Opportunities. Phys Occup Ther Pediatr. 2022;42(5):510-525. doi: 10.1080/01942638.2022.2054301. Epub 2022 Mar 29.
- Derived from this study: PubMed 33382406Harbourne RT, Dusing SC, Lobo MA, McCoy SW, Koziol NA, Hsu LY, Willett S, Marcinowski EC, Babik I, Cunha AB, An M, Chang HJ, Bovaird JA, Sheridan SM. START-Play Physical Therapy Intervention Impacts Motor and Cognitive Outcomes in Infants With Neuromotor Disorders: A Multisite Randomized Clinical Trial. Phys Ther. 2021 Feb 4;101(2):pzaa232. doi: 10.1093/ptj/pzaa232.
- Derived from this study: PubMed 31012090Marcinowski EC, Tripathi T, Hsu LY, Westcott McCoy S, Dusing SC. Sitting skill and the emergence of arms-free sitting affects the frequency of object looking and exploration. Dev Psychobiol. 2019 Nov;61(7):1035-1047. doi: 10.1002/dev.21854. Epub 2019 Apr 22.
- 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.
Regina T Harbourne, PhD principal investigator
Duquesne University
Sarah W McCoy, PhD principal investigator
University of Washington
Michele A. Lobo, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing START-Play intervention and Business as usual in people with Cerebral Palsy and Developmental Delay, run by Duquesne University at 1 site 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 1 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bayley Scales of Infant Development III (time frame: Baseline, at end of 3 month intervention, and at 12 months post-baseline). 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 NCT02593825, which also lists 6 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 18 Mar 2024.