Cerebral Palsy (CP)
Conditions
Keywords
Cerebral Palsy, Locomotor Training, Physical Therapy
Brief summary
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.
Interventions
OTHERActivities-based locomotor training
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.
OTHERphysical therapy
In this intervention, the child will attend their usual physical therapy sessions.
Sponsors
Baylor University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
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); * Non-ambulatory or not walking as primary means of mobility; * Willing to attend the AB-LT intervention at Fortis Therapy Center in Dripping Springs, Texas for 3 hours/ day, 5 days/week, for 3 weeks; and * Willing to commit to a total of 7 weeks of the study, and to continue their usual care during the time period in which they are not enrolled in the AB-LT intervention.
Exclusion criteria
The child must not have: * • Surgery or botulinum toxin injections in the previous 6 months; * Uncontrolled epilepsy; and * Uncontrolled cardiovascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gross Motor Function Measure (GMFM-66) | 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| functional near infrared spectroscopy (fNIRS) | 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7. | 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. |
| Child Engagement in Daily Life (CEDL) | 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7. | 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. |
Countries
United States
Contacts
CONTACTElizabeth Ardolino, PhD, PT
CONTACTMegan Flores, PhD, PT
PRINCIPAL_INVESTIGATORElizabeth Ardolino, PhD, PT
Baylor University
Outcome results
None listed