Cerebral PalsyNCT05867628
Intensive Activities-based Locomotor Training Program in Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by Baylor University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Activities-based locomotor training (physical therapy)
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Child
Study population: Community sample
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of an Intensive Activities-based Locomotor Training Program on Activity Capacity, Performance, and Participation in Children With Cerebral Palsy
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.
- Conditions
- Cerebral Palsy
- Being tested
- Activities-based locomotor training (physical therapy)
- Keywords
- cerebral palsy, children, activities-based locomotor training, neuroplasticity
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activities-based locomotor training (physical therapy)Other
Also called play-based physical therapy
AB-LT is implemented through a combination of partial body weight supported treadmill training, overground walking, and play-based activities.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6.5 months
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.
Measured: 6.5 months
Pediatric Evaluation of Disability Inventory (PEDI-CAT)
Pediatric Evaluation of Disability Inventory:
Measured: 6.5 months
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.
Measured: 6.5 months
Functional near-infrared spectroscopy
Non-invasive, continuous wave functional near-infrared spectroscopy using an OctaMon+ (Artinis Medical Systems, Lieden, Netherlands) to identify metabolic changes and track oxygenation status.
Measured: 6.5 months
Electromyography
Electrodes will measure voluntary (child is asked to perform a movement) and reflex activities (patellar reflex, achilles reflex, triceps reflex) of the dominant limbs.
Measured: 6.5 months
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).
Measured: 6.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan B Flores, Principal investigator, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867628
- Sponsor's protocol ID
- 1922152-2
- Status last verified
- Sep 2025
- First submitted
- 17 Apr 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Intensive Activities-based Locomotor Training Program on Activity Capacity, Performance, and Participation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05867628
- Acronym / sponsor ID
- 1922152-2
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, children, activities-based locomotor training, neuroplasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Community sample
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activities-based locomotor training (physical therapy)Also: play-based physical therapyAB-LT is implemented through a combination of partial body weight supported treadmill training, overground walking, and play-based activities. | Other | – |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan B Flores principal investigator
Baylor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Baylor University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure-66 (GMFM) (time frame: 6.5 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.