Activities-based Locomotor Training in Children With Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Activities-based locomotor training, physical therapy.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy (CP). Basic parameters: 2 years — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Activities-based Locomotor Training in Children With Cerebral Palsy.
Overview
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
- Other Activities-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. - Other physical therapy
In this intervention, the child will attend their usual physical therapy sessions.
Primary outcome measures
- Gross Motor Function Measure (GMFM-66) [Time frame: 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.]
Secondary outcome measures (2)
- functional near infrared spectroscopy (fNIRS) [Time frame: 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.]
- Child Engagement in Daily Life (CEDL) [Time frame: 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Fortis Therapy Center — Dripping Springs
Identifiers
NCT: NCT07184411 · 2245497 · 1R15HD119622-01