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ClinicalTrials.gov Identifier: NCT05867628
Recruitment Status : Enrolling by invitation
First Posted : May 22, 2023
Last Update Posted : May 22, 2023
Sponsor:
Information provided by (Responsible Party):
Baylor University
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Brief 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.
Cerebral Palsy
Other: Activities-based locomotor training (physical therapy)
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Study Type :
Observational
Estimated Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Impact of an Intensive Activities-based Locomotor Training Program on Activity Capacity, Performance, and Participation in Children With Cerebral Palsy
Actual Study Start Date :
February 1, 2023
Estimated Primary Completion Date :
May 30, 2026
Estimated Study Completion Date :
May 30, 2026
Resource links provided by the National Library of Medicine
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Intervention Details:
Other: Activities-based locomotor training (physical therapy)
AB-LT is implemented through a combination of partial body weight supported treadmill training, overground walking, and play-based activities.
Other Name: play-based physical therapy
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Primary Outcome Measures :
Gross Motor Function Measure-66 (GMFM) [ Time Frame: 6.5 months ]
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 (PedsNRS) [ Time Frame: 6.5 months ]
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.
Pediatric Evaluation of Disability Inventory (PEDI-CAT) [ Time Frame: 6.5 months ]
Pediatric Evaluation of Disability Inventory:
Pediatric Quality of Life Inventory CP Module (PedsQL-CP) [ Time Frame: 6.5 months ]
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.
Functional near-infrared spectroscopy [ Time Frame: 6.5 months ]
Non-invasive, continuous wave functional near-infrared spectroscopy using an OctaMon+ (Artinis Medical Systems, Lieden, Netherlands) to identify metabolic changes and track oxygenation status.
Electromyography [ Time Frame: 6.5 months ]
Electrodes will measure voluntary (child is asked to perform a movement) and reflex activities (patellar reflex, achilles reflex, triceps reflex) of the dominant limbs.
ActiGraph sensors [ Time Frame: 6.5 months ]
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).
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Information from the National Library of Medicine
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Ages Eligible for Study: Â
2 Years to 12 Years  (Child)
Sexes Eligible for Study: Â
All
Sampling Method: Â
Non-Probability Sample
Community sample
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.
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05867628
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Baylor University
Waco, Texas, United States, 76798
Baylor University
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Principal Investigator:
Megan B Flores
Baylor University
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Responsible Party:
Baylor University
ClinicalTrials.gov Identifier:
NCT05867628 Â Â
Other Study ID Numbers:
1922152-2
First Posted:
May 22, 2023 Â Â Key Record Dates
Last Update Posted:
May 22, 2023
Last Verified:
April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Baylor University:
cerebral palsychildrenactivities-based locomotor trainingneuroplasticity
Additional relevant MeSH terms:
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ParalysisCerebral PalsyNeurologic ManifestationsNervous System Diseases
Brain Damage, ChronicBrain DiseasesCentral Nervous System Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
