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| ID | Type | Description | Link |
|---|---|---|---|
| 1R15HD119622-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This project aims to improve the quality of life and functional outcomes for young non-ambulatory children with Cerebral Palsy (CP) by investigating the efficacy of an Activities-Based Locomotor Training (AB-LT) program compared to usual care. By targeting the body structures, activities, and participation components of the World Health Organization's International Classification of Functioning, Disability, and Health (ICF) framework, this study seeks to enhance our understanding of neuroplasticity and motor learning in this population, offering a novel approach to rehabilitation. Results from this research will lead to more effective, individualized therapies that improve motor function, reduce disability, and ultimately lower the long-term healthcare needs associated with CP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activities-based locomotor training (AB-LT) | Experimental | Child will participate in a 3-week intensive AB-LT training program. The child will attend the AB-LT session for a total of 3 hours, 5 days a week for 3 weeks. The AB-LT session will consist of 1 hour of walking and standing in a harness on a treadmill, followed by an hour of play-based physical therapy, then followed by a final 1 hour of walking and standing in a harness on a treadmill. All sessions will be run by a licensed physical therapist who is trained in AB-LT. |
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| Usual care | Active Comparator | During this arm, the child will resume or continue their usual therapy schedule, which may include physical therapy, occupational therapy, and/or speech language pathology. No restrictions will be placed on the type or amount of therapy in which the child can participate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activities-based locomotor training | Other | Activities-based locomotor training involves placing the child in a partial body-weight supported (PBWS) system over a treadmill. The child is given assistance by trained clinicians to attempt standing and walking on the treadmill for 1 hour. The child then participates in play-based activities aimed to foster independence in an overground (regular) environment for 1 hour. The final hour of the 3-hour session is conducted in the PBWS system with a focus on standing and walking. |
| Measure | Description | Time Frame |
|---|---|---|
| Gross Motor Function Measure (GMFM-66) | The GMFM-66 is the gold standard for measuring gross motor function in children with CP. A child's capabilities are scored across five dimensions (66 items), including Lying and Rolling (Dimension A), Sitting (Dimension B), Crawling and Kneeling (Dimension C), Standing (Dimension D), and Walking, Running, and Jumping (Dimension E). | 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7. |
| Measure | Description | Time Frame |
|---|---|---|
| functional near infrared spectroscopy (fNIRS) | functional near-infrared spectroscopy (fNIRS) is a non-invasive neuroimaging technique that uses infrared light to assess hemodynamic shifts in the prefrontal cortex during movement. It involves wearing a lightweight neoprene headband that contains sensors. | 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7. |
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Inclusion Criteria: To be eligible for this study, the child must be:
• Able to hold their head upright for 5 seconds when supported at the trunk in sitting (the minimal amount of head control necessary for safe walking on the partial body weight support system during the AB-LT intervention);
Exclusion Criteria: The child must not have:
• Surgery or botulinum toxin injections in the previous 6 months;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Ardolino, PhD, PT | Contact | 215-605-9319 | liz_ardolino@baylor.edu | |
| Megan Flores, PhD, PT | Contact | megan_flores@baylor.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Ardolino, PhD, PT | Baylor University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortis Therapy Center | Recruiting | Dripping Springs | Texas | 78620 | United States |
De-identified raw data includes child functional near infrared spectroscopy (fNIRS), child functional gross motor ability levels obtained from the Gross Motor Function Measure (GMFM-66), Child Engagement in Daily Life survey data collected from primary caregivers, and parent-reported demographic information.
Analyzed data that will be shared at the conclusion of the project includes statistical models, and descriptive analysis.
Data will be made available at the time of associated publication or by the end of the project, whichever comes first. Data will be available in REDCap for at least 10 years.
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| physical therapy | Other | In this intervention, the child will attend their usual physical therapy sessions. |
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| Child Engagement in Daily Life (CEDL) | The Child Engagement in Daily Life (CEDL) is a survey completed by parents or caregivers of children, 18 months through 12 years of age. The CEDL describes a child's participation in daily activities such as interactions with others, play, and self-care. | 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7. |