Cerebral PalsyNCT04561232
Locomotor Learning in Infants at High Risk for Cerebral Palsy
A study testing Prone and Upright Locomotor Training in people with Cerebral Palsy, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The objective of this project is to characterize the evolution of locomotor learning over the first 18 months of life in infants at high risk for cerebral palsy (CP). To characterize how locomotor skill is learned (or not learned) during this critical period, the investigators will combine established protocols using… Read more about this study
- Who is it for?
- Ages Up to 6 weeks
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Prone and Upright Locomotor Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 4 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 6 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- less than 6 weeks of age (corrected for prematurity, if applicable)
- have a history of an early brain injury associated with high risk for cerebral palsy including periventricular leukomalacia, hypoxic-ischemic encephalopathy, intraventricular hemorrhage, hydrocephalus, stroke, neonatal seizures, or intracranial cystic lesion
- family is able to commit to study visits
Who cannot join
- known genetic condition unrelated to cerebral palsy (CP) or congenital abnormalities
- Infants with fidgety movements on the General Movements Assessments (GMA) at 3 months of age or a score greater than -0.5sd below the mean on the Test of Infant Motor Performance at 4 months of age will not progress in the study because these infants are unlikely to have CP.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
The objective of this project is to characterize the evolution of locomotor learning over the first 18 months of life in infants at high risk for cerebral palsy (CP). To characterize how locomotor skill is learned (or not learned) during this critical period, the investigators will combine established protocols using robust, unbiased robotic and sensor technology to longitudinally study infant movement across three consecutive stages during the development of impaired human motor control - early spontaneous movement, prone locomotion (crawling), and upright locomotion (walking).
Read the detailed description
Early spontaneous leg movements will be measured monthly from 1-4 months of age. Infants who remain at high risk for CP by month 4 as measured by the General Movements Assessment and the Test of Infant Motor Performance (TIMP) at 4 months of age will continue to locomotor training phases. Prone locomotor training using the Self-Initiated Prone Progression Crawler (SIPPC) will be delivered from 5-9 months of age. Upright locomotor training with dynamic weight support (DWS) will be delivered from 9-18 months of age. Repeated assessments of locomotor skill, movement quality, training characteristics, and variables that may mediate locomotor learning will be collected at time points from 1 month to 18 months of post-term age.
Investigators will examine the relationships between motor error and locomotor skill acquisition over time, anticipating that experiencing and correcting movement errors is critical to skill acquisition in infants at risk for CP; the contribution of other training characteristics (movement time, movement variability, and postural control) to locomotor learning; and how learning is mediated by neurobehavioral factors outside of training. Investigators will develop comprehensive models of training predictors and mediators for prone and upright locomotor learning.
- Conditions
- Cerebral Palsy
- Being tested
- Prone and Upright Locomotor Training
- Keywords
- cerebral palsy, infant, physical therapy, motor learning, robotics
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone and Upright Locomotor TrainingBehavioural
Also called Crawling therapy, Walking therapy
During the movement observation phase, infants will wear a wireless movement sensor at each ankle for two days. Research staff will show the caregivers how to place the sensors in the morning and charge them overnight.
The training protocol for the prone training will consist of: 1) Warm-up. 2) Assisted movement of the arms and legs. 3) Calibration of the infant's arm and leg positions. 4) Self-initiated mobility for up to five minutes.
For upright training, the environment will be arranged to encourage active motor exploration and variability in walking activities.The therapist will assist the child as needed to encourage upright locomotor activities, but only the minimum amount needed to perform the task. Weight assistance will be gradually reduced as postural control and coordination improve.
| Study group | Role | What they receive |
|---|---|---|
| Locomotor Learning | Other | This study has three phases. The first phase of the study will be the observation of early spontaneous leg movements which will be measured monthly from 1-4 months of age.
The prone locomotor intervention phase using the Self-Initiated Prone Progression Crawler (SIPPC) will occur from 5-9 months of post-term age, or end earlier if the child achieves the ability to crawl six feet. Treatment will occur at an intensity of 3 times per week for 15-30 minutes. Infants will use the SIPPC for the duration of each therapy session
The upright locomotor intervention phase using DWS will occur from 9-18 months of age, or begin earlier if the child achieves the ability to crawl six feet before 9 months of age, and end earlier if the child achieves independent walking before 18 months of age. Treatment will occur at an intensity of 3 times per week for 30 minutes. Infants will receive dynamic weight support (DWS) for the duration of the 30-minute therapy session. Receives: Behavioral: Prone and Upright Locomotor Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure-66
The Gross Motor Function Measure-66 (GMFM-66) is a Rasch-analyzed measure of gross motor function designed for children with cerebral palsy (CP). Computation of the GMFM-66 score involves statistical weighting of the raw item scores for difficulty. Scores range from 0 to 100 with higher scores indicating more functional ability.
Measured: Up to 18 months
Movement Observation Coding System
The Movement Observation Coding System will use video coding to assess postural control, arm and leg movements, and goal directed movement.
Measured: Up to 18 months
Secondary outcomes (7)
Early spontaneous movement
Wearable sensor data will be analyzed to describe leg movements produced across in the natural environment.
Measured: Up to 4 months
Error rate - prone
Error during prone locomotor training will measured using the Self-Initiated Prone Progression Crawler (SIPPC).
Measured: Up to 18 months
Error rate - upright
Error during upright locomotor training will measured using the dynamic weight support (DWS) technology.
Measured: Up to 18 months
Movement index
Movement index is the percent of time moving during each therapy session which will be recorded by sensors.
Measured: Up to 18 months
Postural control
Postural control will be measured from video coding of therapy sessions.
Measured: Up to 18 months
Movement variability - prone
Movement variability during prone locomotor training will be measured using the Self-Initiated Prone Progression Crawler (SIPPC).
Measured: Up to 18 months
Movement variability - upright
Movement variability during upright locomotor training will be measured by video coding.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start15 Dec 2020
- Primary completion4 Aug 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Children's Hospital of PhiladelphiaThe 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Los Angeles, University of Oklahoma, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Laura Prosser, PhD, Principal investigator, Research Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561232
- Sponsor's protocol ID
- 19-016773
- Other IDs
- 1R01HD098364-01A1
- Status last verified
- Jun 2026
- First submitted
- 10 Sep 2020
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pierce SR, Skorup J, Kolobe THA, Smith BA, Prosser LA. Agreement Between the Gross Motor Ability Estimator-2 and the Gross Motor Ability Estimator-3 in Young Children With Cerebral Palsy. Pediatr Phys Ther. 2024 Jan 1;36(1):37-40. doi: 10.1097/PEP.0000000000001065. Epub 2023 Nov 30.
PubMed 38033276Prosser LA, Skorup J, Pierce SR, Jawad AF, Fagg AH, Kolobe THA, Smith BA. Locomotor learning in infants at high risk for cerebral palsy: A study protocol. Front Pediatr. 2023 Feb 23;11:891633. doi: 10.3389/fped.2023.891633. eCollection 2023.
PubMed 36911033
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locomotor Learning in Infants at High Risk for Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04561232
- Acronym / sponsor ID
- 19-016773
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, infant, physical therapy, motor learning, robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Children's Hospital Los Angeles, University of Oklahoma, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 23 Sep 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 objective of this project is to characterize the evolution of locomotor learning over the first 18 months of life in infants at high risk for cerebral palsy (CP). To characterize how locomotor skill is learned (or not learned) during this critical period, the investigators will combine established protocols using robust, unbiased robotic and sensor technology to longitudinally study infant movement across three consecutive stages during the development of impaired human motor control - early spontaneous movement, prone locomotion (crawling), and upright locomotion (walking).
Detailed description
Early spontaneous leg movements will be measured monthly from 1-4 months of age. Infants who remain at high risk for CP by month 4 as measured by the General Movements Assessment and the Test of Infant Motor Performance (TIMP) at 4 months of age will continue to locomotor training phases. Prone locomotor training using the Self-Initiated Prone Progression Crawler (SIPPC) will be delivered from 5-9 months of age. Upright locomotor training with dynamic weight support (DWS) will be delivered from 9-18 months of age. Repeated assessments of locomotor skill, movement quality, training characteristics, and variables that may mediate locomotor learning will be collected at time points from 1 month to 18 months of post-term age.
Investigators will examine the relationships between motor error and locomotor skill acquisition over time, anticipating that experiencing and correcting movement errors is critical to skill acquisition in infants at risk for CP; the contribution of other training characteristics (movement time, movement variability, and postural control) to locomotor learning; and how learning is mediated by neurobehavioral factors outside of training. Investigators will develop comprehensive models of training predictors and mediators for prone and upright locomotor learning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locomotor Learning | Other | Behavioral: Prone and Upright Locomotor TrainingThis study has three phases. The first phase of the study will be the observation of early spontaneous leg movements which will be measured monthly from 1-4 months of age. The prone locomotor intervention phase using the Self-Initiated Prone Progression Crawler (SIPPC) will occur from 5-9 months of post-term age, or end earlier if the child achieves the ability to crawl six feet. Treatment will occur at an intensity of 3 times per week for 15-30 minutes. Infants will use the SIPPC for the duration of each therapy session The upright locomotor intervention phase using DWS will occur from 9-18 months of age, or begin earlier if the child achieves the ability to crawl six feet before 9 months of age, and end earlier if the child achieves independent walking before 18 months of age. Treatment will occur at an intensity of 3 times per week for 30 minutes. Infants will receive dynamic weight support (DWS) for the duration of the 30-minute therapy session. |
Who may qualify
- Ages
- Up to 6 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- less than 6 weeks of age (corrected for prematurity, if applicable)
- have a history of an early brain injury associated with high risk for cerebral palsy including periventricular leukomalacia, hypoxic-ischemic encephalopathy, intraventricular hemorrhage, hydrocephalus, stroke, neonatal seizures, or intracranial cystic lesion
- family is able to commit to study visits
Key exclusion criteria (2 listed)
- known genetic condition unrelated to cerebral palsy (CP) or congenital abnormalities
- Infants with fidgety movements on the General Movements Assessments (GMA) at 3 months of age or a score greater than -0.5sd below the mean on the Test of Infant Motor Performance at 4 months of age will not progress in the study because these infants are unlikely to have CP.
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 |
|---|---|---|
| Prone and Upright Locomotor TrainingAlso: Crawling therapy, Walking therapyDuring the movement observation phase, infants will wear a wireless movement sensor at each ankle for two days. Research staff will show the caregivers how to place the sensors in the morning and charge them overnight. The training protocol for the prone training will consist of: 1) Warm-up. 2) Assisted movement of the arms and legs. 3) Calibration of the infant's arm and leg positions. 4) Self-initiated mobility for up to five minutes. For upright training, the environment will be arranged to encourage active motor exploration and variability in walking activities.The therapist will assist the child as needed to encourage upright locomotor activities, but only the minimum amount needed to perform the task. Weight assistance will be gradually reduced as postural control and coordination improve. | Behavioural | Locomotor Learning |
Primary outcome
Gross Motor Function Measure-66
Time frame: Up to 18 months
The Gross Motor Function Measure-66 (GMFM-66) is a Rasch-analyzed measure of gross motor function designed for children with cerebral palsy (CP). Computation of the GMFM-66 score involves statistical weighting of the raw item scores for difficulty. Scores range from 0 to 100 with higher scores indicating more functional ability.
Movement Observation Coding System
Time frame: Up to 18 months
The Movement Observation Coding System will use video coding to assess postural control, arm and leg movements, and goal directed movement.
7 secondary outcomes
Early spontaneous movement
Time frame: Up to 4 months
Error rate - prone
Time frame: Up to 18 months
Error rate - upright
Time frame: Up to 18 months
Movement index
Time frame: Up to 18 months
Postural control
Time frame: Up to 18 months
Movement variability - prone
Time frame: Up to 18 months
Movement variability - upright
Time frame: Up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Derived from this study: PubMed 38033276Pierce SR, Skorup J, Kolobe THA, Smith BA, Prosser LA. Agreement Between the Gross Motor Ability Estimator-2 and the Gross Motor Ability Estimator-3 in Young Children With Cerebral Palsy. Pediatr Phys Ther. 2024 Jan 1;36(1):37-40. doi: 10.1097/PEP.0000000000001065. Epub 2023 Nov 30.
- Derived from this study: PubMed 36911033Prosser LA, Skorup J, Pierce SR, Jawad AF, Fagg AH, Kolobe THA, Smith BA. Locomotor learning in infants at high risk for cerebral palsy: A study protocol. Front Pediatr. 2023 Feb 23;11:891633. doi: 10.3389/fped.2023.891633. eCollection 2023.
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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.
Laura Prosser, PhD principal investigator
Research Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone and Upright Locomotor Training in people with Cerebral Palsy, run by Children's Hospital of Philadelphia 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 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: finished, as of the sponsor's last update on 29 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gross Motor Function Measure-66 (time frame: Up to 18 months). The study lists 2 primary outcomes in all. 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 NCT04561232, which also lists 2 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 29 Jun 2026.