CompletedNot Applicable

Intensive Activities-based Locomotor Training Program in Children With Cerebral Palsy

United States7 participantsStarted 2023-02-01

Plain-language summary

The goal of the proposed work is to investigate the impact of an intensive 3-week activities-based locomotor training (AB-LT) program on activity capacity, activity performance, and participation in children with cerebral palsy (CP). Caregiver perspectives will provide a holistic assessment of the program.

Who can participate

Age range

2 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Intervention: Participants will be included if they have a diagnosis of CP and are between the ages of 2 to 12 years. They must also be enrolled in the 3-week AB-LT program at Fortis Therapy Center. Parent Interview: Participants will be included if they are the parent or guardian (any age) of a child who participated in the 3-week AB-LT program and attended at least 3 sessions with their child. Exclusion Criteria: * Intervention study: Participants will be excluded if they have had surgery or botulinum toxin injections in the previous 6 months or have uncontrolled epilepsy or cardiovascular disease. Parent Interview: Participants will be excluded if they have not attended at least 3 AB-LT sessions with their child.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gross Motor Function Measure-66 (GMFM)

Timeframe: 6.5 months

Pediatric Neuromuscular Recovery Scale (PedsNRS)

Timeframe: 6.5 months

Pediatric Evaluation of Disability Inventory (PEDI-CAT)

Timeframe: 6.5 months

Pediatric Quality of Life Inventory CP Module (PedsQL-CP)

Timeframe: 6.5 months

Functional near-infrared spectroscopy

Timeframe: 6.5 months

Electromyography

Timeframe: 6.5 months

ActiGraph sensors

Timeframe: 6.5 months

Trial details

NCT IDNCT05867628

SponsorBaylor University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-01

View on ClinicalTrials.gov More Cerebral Palsy trials

Plain-language summary

Who can participate

Age range

2 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Gross Motor Function Measure-66 (GMFM)

Timeframe: 6.5 months

Pediatric Neuromuscular Recovery Scale (PedsNRS)

Timeframe: 6.5 months

Pediatric Evaluation of Disability Inventory (PEDI-CAT)

Timeframe: 6.5 months

Pediatric Quality of Life Inventory CP Module (PedsQL-CP)

Timeframe: 6.5 months

Functional near-infrared spectroscopy

Timeframe: 6.5 months

Electromyography

Timeframe: 6.5 months

ActiGraph sensors

Timeframe: 6.5 months