Cerebral PalsyNCT04886895
Motor Training for Infants With Cerebral Palsy
A study testing Let's Move Motor Intervention in people with Cerebral Palsy, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The intervention in this study, Let's Move, is a motor intervention for infants at risk for cerebral palsy. We will test the feasibility and acceptability of the intervention as well as preliminary effectiveness. Read more about this study
- Who is it for?
- Ages 3 to 8 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Let's Move Motor Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2022to 1 Jan 2028
- 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 3 to 8 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age at enrollment: between 3-8 months corrected age
- Caregivers fluent in English
- Preterm infants with objectively defined severe diffuse white matter abnormality on MRI at term OR
- High-risk infants (e.g., preterm, neonatal hypoxic-ischemic encephalopathy, perinatal stroke) with moderate-severe injury on structural MRI or cranial ultrasound (e.g., basal ganglia/thalamic signal intensity, cystic periventricular leukomalacia, encephalomalacia, large stroke, and/or severe intraventricular/periventricular hemorrhage) at around term-equivalent age or before Neonatal Intensive Care Unit discharge AND either:
- "Absent" fidgety movements based on the Prechtl General Movement Assessment (GMA) between 3-4 months corrected age OR
- A score of 56 or below on the Hammersmith Infant Neuromotor Examination (HINE) between 3-6 months corrected age (31)
Who cannot join
- Medical conditions that restrict active participation such as oxygen dependence
- Infants with significant visual deficits defined by the inability to track an object horizontally
- Living in a remote location prohibiting drives to the hospital every other week.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Karen L Harpster, PhD, OTR/L, 513-803-3604, karen.harpster@cchmc.org
Nehal A Parikh, DO, MS, 513 517-1044, nehal.parikh@cchmc.org
About this study
Official title: Motor Training Intervention for Infants at High-Risk for Cerebral Palsy: Feasibility and Acceptability
The intervention in this study, Let's Move, is a motor intervention for infants at risk for cerebral palsy. We will test the feasibility and acceptability of the intervention as well as preliminary effectiveness.
Read the detailed description
The aims of this study are to test the feasibility, acceptability, and operationalize a novel motor intervention, called "Let's Move" delivered using a combined clinic and home (video telehealth) therapy model.
- Conditions
- Cerebral Palsy
- Being tested
- Let's Move Motor Intervention
- Keywords
- motor skills, occupational therapy, 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.
Let's Move Motor InterventionOther
Let's Move intervention will be administered and videotaped with infant/caregiver dyads. Therapy will occur weekly (30-60 minutes per session) for 16 weeks, alternating between clinic and home (video telehealth) sessions. Each month, we will attempt to schedule two clinic-based sessions followed by 2 telehealth-based sessions
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Infants randomized to the usual care arm will receive usual care for 4 months. Therapy services provided to infants at this age vary in terms of frequency, location, and provider. Usual care is prescribed by the child's primary care provider (PCP), and in this population, usual care typically consists of one or both of the following: Early intervention therapy services provided by the state or Therapy in an outpatient clinic. Control group participants will be offered the Let's Move interventions after 16 weeks of control group. Receives: Other: Let's Move Motor Intervention |
| Intervention group: Let's Move | Experimental | Infants randomized to the Let's Move intervention group will be scheduled for therapy one time per week for 16 sessions (approximately 30-60 minutes per session). The intervention setting will involve both in-person (CCHMC clinic or in-home) and telehealth (in-home, video-based) sessions. The therapist will provide the caregivers with home programs to complete between therapy sessions (5 days per week). The home program will be based on the infant's goals set collaboratively between the caregiver and the evaluating therapist at the baseline assessment using the Canadian Occupational Performance Measure (COPM). At least half of the intervention sessions will be video recorded to assess feasibility and monitor intervention fidelity. Receives: Other: Let's Move Motor Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up
Motor test
Measured: Baseline,16 weeks, 28 weeks
Secondary outcomes (4)
Change on Pediatric Evaluation of Disability Inventory-Computer Adaptive Test before and after intervention and follow-up
Parent reported test for functional performance
Measured: Baseline,16 weeks, 28 weeks
Change on Canadian Occupational Performance Measure before and after intervention and follow-up
Caregivers perception of child's performance on functional goals
Measured: Baseline,16 weeks, 28 weeks
Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up
Neurological exam
Measured: Baseline,16 weeks, 28 weeks
Preverbal visual assessment (PreViAs
Screening tool for the development of visual maturation
Measured: Enrollment, 4 months later, 8 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start7 Jan 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Crossover
- Model description
- Single cohort
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Harpster, Children's Hospital Medical Center, Cincinnati
- Investigators
- Karen Harpster, PhD, OTR/L, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886895
- Sponsor's protocol ID
- 2021-0305
- Status last verified
- Sep 2025
- First submitted
- 29 Apr 2021
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Training Intervention for Infants at High-Risk for Cerebral Palsy: Feasibility and Acceptability
- ClinicalTrials.gov ID
- NCT04886895
- Acronym / sponsor ID
- 2021-0305
- Conditions
- Cerebral Palsy
- Keywords
- motor skills, occupational therapy, physical therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 14 May 2021 (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 intervention in this study, Let's Move, is a motor intervention for infants at risk for cerebral palsy. We will test the feasibility and acceptability of the intervention as well as preliminary effectiveness.
Detailed description
The aims of this study are to test the feasibility, acceptability, and operationalize a novel motor intervention, called "Let's Move" delivered using a combined clinic and home (video telehealth) therapy model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single cohort
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Let's Move Motor InterventionInfants randomized to the usual care arm will receive usual care for 4 months. Therapy services provided to infants at this age vary in terms of frequency, location, and provider. Usual care is prescribed by the child's primary care provider (PCP), and in this population, usual care typically consists of one or both of the following: Early intervention therapy services provided by the state or Therapy in an outpatient clinic. Control group participants will be offered the Let's Move interventions after 16 weeks of control group. |
| Intervention group: Let's Move | Experimental | Other: Let's Move Motor InterventionInfants randomized to the Let's Move intervention group will be scheduled for therapy one time per week for 16 sessions (approximately 30-60 minutes per session). The intervention setting will involve both in-person (CCHMC clinic or in-home) and telehealth (in-home, video-based) sessions. The therapist will provide the caregivers with home programs to complete between therapy sessions (5 days per week). The home program will be based on the infant's goals set collaboratively between the caregiver and the evaluating therapist at the baseline assessment using the Canadian Occupational Performance Measure (COPM). At least half of the intervention sessions will be video recorded to assess feasibility and monitor intervention fidelity. |
Who may qualify
- Ages
- 3 to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age at enrollment: between 3-8 months corrected age
- Caregivers fluent in English
- Preterm infants with objectively defined severe diffuse white matter abnormality on MRI at term OR
- High-risk infants (e.g., preterm, neonatal hypoxic-ischemic encephalopathy, perinatal stroke) with moderate-severe injury on structural MRI or cranial ultrasound (e.g., basal ganglia/thalamic signal intensity, cystic periventricular leukomalacia, encephalomalacia, large stroke, and/or severe intraventricular/periventricular hemorrhage) at around term-equivalent age or before Neonatal Intensive Care Unit discharge AND either:
Key exclusion criteria (3 listed)
- Medical conditions that restrict active participation such as oxygen dependence
- Infants with significant visual deficits defined by the inability to track an object horizontally
- Living in a remote location prohibiting drives to the hospital every other week.
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 |
|---|---|---|
| Let's Move Motor InterventionLet's Move intervention will be administered and videotaped with infant/caregiver dyads. Therapy will occur weekly (30-60 minutes per session) for 16 weeks, alternating between clinic and home (video telehealth) sessions. Each month, we will attempt to schedule two clinic-based sessions followed by 2 telehealth-based sessions | Other | Control group, Intervention group: Let's Move |
Primary outcome
Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up
Time frame: Baseline,16 weeks, 28 weeks
Motor test
4 secondary outcomes
Change on Pediatric Evaluation of Disability Inventory-Computer Adaptive Test before and after intervention and follow-up
Time frame: Baseline,16 weeks, 28 weeks
Change on Canadian Occupational Performance Measure before and after intervention and follow-up
Time frame: Baseline,16 weeks, 28 weeks
Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up
Time frame: Baseline,16 weeks, 28 weeks
Preverbal visual assessment (PreViAs
Time frame: Enrollment, 4 months later, 8 months later
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 25 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Karen Harpster, PhD, OTR/L principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Let's Move Motor Intervention in people with Cerebral Palsy, run by Children's Hospital Medical Center, Cincinnati 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 6 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: looking for participants now, as of the sponsor's last update on 25 Sep 2025. 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?
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?
Contact Karen Harpster, PhD, OTR/L (513-803-3604, karen.harpster@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up (time frame: Baseline,16 weeks, 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2025.