Activities-based Locomotor Training in Children With Cerebral Palsy
ConditionCerebral Palsy (CP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-6
SponsorBaylor University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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.
Disqualifiers
• Surgery or botulinum toxin injections in the previous 6 months;
Uncontrolled epilepsy; and
Uncontrolled cardiovascular disease
Trial design
Design model
Crossover
Treatments tested in this trial
Activities-based locomotor training
Other interventionActivities-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.
physical therapy
Other interventionIn this intervention, the child will attend their usual physical therapy sessions.
Treatment groups
19 Participants
are divided into 2 treatment groupsGroup A: Activities-based locomotor training (AB-LT)Experimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.Secondary outcomes
1
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.
Time frame
4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.2
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.
Time frame
4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Baylor University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov