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

NCT06352814 | Completed

• 1 other identifier: 1977152
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; children; activities-based locomotor training; neuroplasticity

Outcome Measures

Primary Outcomes (7)

• Gross Motor Function Measure-66 (GMFM)

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

  9 weeks

• Pediatric Neuromuscular Recovery Scale (PedsNRS)

  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.

  9 weeks

• Pediatric Evaluation of Disability Inventory (PEDI-CAT)

  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.

  9 weeks

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

  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.

  9 weeks

• Functional near-infrared spectroscopy

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

  9 weeks

• Electromyography

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

  9 weeks

• ActiGraph sensors

  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.

  9 weeks

Study Arms (1)

ABLT vs traditional PT

Activities-based locomotor training is implemented through a combination of partial body weight supported treadmill training, overground walking, and play-based activities.

Other: Activities-based locomotor training (physical therapy)

Interventions

Activities-based locomotor training (physical therapy) OTHER

AB-LT is implemented through a combination of partial body weight supported treadmill training, overground walking, and play-based activities.

ABLT vs traditional PT

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Community sample (central Texas)

You may qualify if:

• 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.

You may not qualify if:

• Surgery or botulinum toxin injections in the previous 6 months
• Uncontrolled epilepsy or cardiovascular disease.

Sponsors & Collaborators

• Baylor University: lead

Study Sites (1)

Baylor University

Waco, Texas, 76798, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Megan Flores

  Baylor University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 8, 2024
• Study Start: March 8, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)