Completed

Activities-based Locomotor Training Program Versus Traditional Physical Therapy in Children With Cerebral Palsy

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What is being collected

Data Collection

Collected from today forward - Prospective
Other
Who is being recruted

Cerebral Palsy

From 2 to 6 Years
+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Case-Crossover

Comparing exposures during disease occurrence and non-occurrence in order to assess the short-term effects of triggers.
Observational
Study Start: March 2024

See protocol details

Summary

Principal SponsorBaylor University
Last updated: July 18, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: March 8, 2024Actual date on which the first participant was enrolled.

The purpose of this study is to investigate the impact of an intensive activities-based locomotor training program as compared to traditional physical therapy on activity, participation, and central and peripheral neurophysiological adaptation in children with cerebral palsy. Observational research will be performed to assess the change in outcome measure scores over time among participants after the AB-LT intervention. Outcome measures will be obtained 4 times, occurring every 3 weeks over a period of 9 weeks: pre-intervention, post-intervention, pre-traditional therapy, and post-traditional therapy. A washout period of 3 weeks will occur between the AB-LT intervention and traditional therapy.

Official TitleImpact of an Activities-based Locomotor Training Program Versus Traditional Physical Therapy in Children With Cerebral Palsy on Activity, Participation, and Neurophysiological Adaptations 
Principal SponsorBaylor University
Last updated: July 18, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
6 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Case-Crossover
In this design, participants serve as their own control. Researchers compare a person's exposures just before a health event with exposures at other times, helping identify short-term triggers or risk factors.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective: These studies use existing medical records or past data.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 2 to 6 YearsRange of ages for which participants are eligible to join.
Conditions
Pathology
Cerebral Palsy
Criteria
3 inclusion criteria required to participate
Diagnosis of CP
Between the ages of 2 to 12 years
Enrolled in a 3-week AB-LT program and/or participate in traditional physical therapy
2 exclusion criteria prevent from participating
Surgery or botulinum toxin injections in the previous 6 months
Uncontrolled epilepsy or cardiovascular disease

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Activities-based locomotor training is implemented through a combination of partial body weight supported treadmill training, overground walking, and play-based activities.
Study Objectives
Primary Objectives

Gross Motor Function Measure-66: Items scored on 0-3 scale. Minimum value: 0. Maximum value: 99. Higher scores indicate better outcome.

Pediatric Neuromuscular Recovery Scale: Each of the 13 items on the Peds NRS have 12 phases. Each item is scored on a 12-point scale, with one point allocated to each phase of the item. The age-appropriate item cards instruct the rater to begin at a designated "start phase" indicated by a bold box around the phase within the 12 phases on each card. If the child cannot perform the movement as listed in the start phase (which may be midway through the card), the rater starts at the beginning of the item card and assesses the child's performance at the first phase for that item. The rater continues sequentially through the 12 phases on the card until the child is unable to perform a phase. The rater scores the highest phase achieved by the child and moves on to the next item card, through all 13 items. Items are then summed into a summary Peds NRS score using an algorithm.

Parent questionnaire about child's mobility and activitiies of daily living. Normative Standard Scores: provided as age percentiles and T-scores Scaled Scores (criterion scores): 20-80 scale.

For each of the 4 domains, in addition to scaled scores, normative standard scores (provided as T-scores and age percentiles) are calculated. Normative scores describe the child's performance in comparison to other children of the same age (in one year intervals). For T-scores, the mean for each age group is 50, with a standard deviation of 10 (same format used for normative scores in the original PEDI). Typically, T-scores between 30 and 70 (i.e. mean ± 2 standard deviations) are considered within the expected range for age. Scores below 30 indicate decreased functional ability compared to what is typically expected for that age range. Scores above 70 indicate scores above what is typically expected for that age range. Higher scores indicate better outcome.

Non-invasive, continuous wave functional near-infrared spectroscopy using an OctaMon+ (Artinis Medical Systems, Lieden, Netherlands) to track oxygenation status.

Electrodes will measure electrical activity in response to reflex stimulation of the muscle of the dominant limbs.

Activity performance will be measured using ActiGraph accelerometers, which are motion sensors worn as a bracelet around the rist designed to detect movement when worn. They have excellent inter-instrument reliability (ICC = 0.98). Physical activity data will be expressed in average counts per minute (CPM) on the basis of the vector magnitude of the triaxial accelerometer. In general, higher average CPM represents a more active child.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Baylor UniversityWaco, United StatesSee the location
CompletedOne Study Center