Cerebral PalsyNCT06027580
Orthosis to Improve Trunk Control in Infants Age 6-18 Months
An observational study of Cerebral Palsy, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this study is to determine the impact of the SPIO® Core-MAX® Expedition orthosis on an infant's head, trunk and upper limb function. Read more about this study
- Who is it for?
- Ages 6 to 18 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- SPIO® Core-MAX® Expedition thoracolumbosacral orthosis
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2026to 6 Aug 2026
- 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 6 to 18 months
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 6 months to 18 months age corrected with abnormal muscle tone assessed by a provider as likely to benefit from use of a compression garment.
Who may be able to join
- Study subjects aged 6 months to 18 months age corrected with abnormal muscle tone
- No previous use of SPIO® or similar Lycra/compression garments
- Assessed by provider as likely to benefit from use of compression garment
Who cannot join
- Non-English speaking
- Inability for family to bring study subject to assessments
- Orthosis or casting that contraindicate SPIO® Core-MAX® during the study period
- Botulinum toxin injections within 3 months, or during study participation
- Having prior orthopedic or neurosurgery surgeries within one year
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin/Children's Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Assessing Functional Improvements With Use of the SPIO Core-Max Expedition TLSO
The purpose of this study is to determine the impact of the SPIO® Core-MAX® Expedition orthosis on an infant's head, trunk and upper limb function.
Read the detailed description
This study will observe the difference in outcomes between two courses of standard clinical care: therapy or therapy with the SPIO® Core-MAX® Expedition orthosis. Families will self-select that standard care option that works best for their family, and outcomes will be observed at baseline, 3 months and 6 months.
- Conditions
- Cerebral Palsy
- Being tested
- SPIO® Core-MAX® Expedition thoracolumbosacral orthosis, Standard Care Therapy option
- Keywords
- abnormal muscle tone, cerebral palsy, hypotonia, muscle tone, spasticity
- Medical subject headings
- Cerebral Palsy, Muscle Hypotonia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPIO® Core-MAX® Expedition thoracolumbosacral orthosisDevice
SPIO® Core-MAX® Expedition thoracolumbosacral orthosis use 2 hours per day for 6 months
Standard Care Therapy optionOther
Standard of care Therapy without the use of trunk orthosis
| Study group | Role | What they receive |
|---|---|---|
| SPIO group | Standard Care Therapy option 1: parents may self-select this standard care combined option of therapy and use of SPIO® Core-MAX® Expedition thoracolumbosacral orthosis Receives: Device: SPIO® Core-MAX® Expedition thoracolumbosacral orthosis | |
| Control group | Standard Care Therapy option 2: parents may self-select this standard care option of therapy alone Receives: Other: Standard Care Therapy option |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in head and trunk position from centerline at baseline, 3-months and 6-months.
Degree change in head and trunk position from centerline as assessed by motion capture.
Measured: Through study completion, an average of 2 years
Change from baseline to 3-months and 6-months on the Pediatric Quality of Life Inventory Infant Scale.
The Pediatric Quality of Life Inventory Infant Scales (PedQL-I) is used to assess parent-reported health-related quality of life for children with ages 1-12 months or 12-24 months. It has the same five components, including physical functioning (6 items), physical symptoms (10 items), emotional functions (12 items), social functioning (4 items), and cognitive functioning (4 items) with scale from 0 to 4.
0 if it is never a problem
- if it is almost never a problem
- if it is sometimes a problem
- if it is often a problem
- if it is almost always a problem
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start6 Aug 2026
- Primary completion6 Aug 2026
- Study completion6 Aug 2026
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.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- SPIO
- Responsible party
- Principal investigator, Mitchell O'Neill, Medical College of Wisconsin
- Investigators
- Mitchell O'Neill, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027580
- Sponsor's protocol ID
- PRO00048530
- Status last verified
- Jan 2026
- First submitted
- 9 Aug 2023
- Last updated
- 8 Oct 2026
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Functional Improvements With Use of the SPIO Core-Max Expedition TLSO
- ClinicalTrials.gov ID
- NCT06027580
- Acronym / sponsor ID
- PRO00048530
- Conditions
- Cerebral Palsy
- Keywords
- abnormal muscle tone, cerebral palsy, hypotonia, muscle tone, spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- SPIO
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 6 Aug 2026 (actual)
- Study completion
- 6 Aug 2026 (actual)
- First posted
- 7 Sep 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 purpose of this study is to determine the impact of the SPIO® Core-MAX® Expedition orthosis on an infant's head, trunk and upper limb function.
Detailed description
This study will observe the difference in outcomes between two courses of standard clinical care: therapy or therapy with the SPIO® Core-MAX® Expedition orthosis. Families will self-select that standard care option that works best for their family, and outcomes will be observed at baseline, 3 months and 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPIO group | – | Device: SPIO® Core-MAX® Expedition thoracolumbosacral orthosisStandard Care Therapy option 1: parents may self-select this standard care combined option of therapy and use of SPIO® Core-MAX® Expedition thoracolumbosacral orthosis |
| Control group | – | Other: Standard Care Therapy optionStandard Care Therapy option 2: parents may self-select this standard care option of therapy alone |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 6 months to 18 months age corrected with abnormal muscle tone assessed by a provider as likely to benefit from use of a compression garment.
Key inclusion criteria (3 listed)
- Study subjects aged 6 months to 18 months age corrected with abnormal muscle tone
- No previous use of SPIO® or similar Lycra/compression garments
- Assessed by provider as likely to benefit from use of compression garment
Key exclusion criteria (5 listed)
- Non-English speaking
- Inability for family to bring study subject to assessments
- Orthosis or casting that contraindicate SPIO® Core-MAX® during the study period
- Botulinum toxin injections within 3 months, or during study participation
- Having prior orthopedic or neurosurgery surgeries within one year
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 |
|---|---|---|
| SPIO® Core-MAX® Expedition thoracolumbosacral orthosisSPIO® Core-MAX® Expedition thoracolumbosacral orthosis use 2 hours per day for 6 months | Device | SPIO group |
| Standard Care Therapy optionStandard of care Therapy without the use of trunk orthosis | Other | Control group |
Primary outcome
Change in head and trunk position from centerline at baseline, 3-months and 6-months.
Time frame: Through study completion, an average of 2 years
Degree change in head and trunk position from centerline as assessed by motion capture.
Change from baseline to 3-months and 6-months on the Pediatric Quality of Life Inventory Infant Scale.
Time frame: Through study completion, an average of 2 years
The Pediatric Quality of Life Inventory Infant Scales (PedQL-I) is used to assess parent-reported health-related quality of life for children with ages 1-12 months or 12-24 months. It has the same five components, including physical functioning (6 items), physical symptoms (10 items), emotional functions (12 items), social functioning (4 items), and cognitive functioning (4 items) with scale from 0 to 4. 0 if it is never a problem 1. if it is almost never a problem 2. if it is sometimes a problem 3. if it is often a problem 4. if it is almost always a problem
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 8 Oct 2026.
- 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.
Mitchell O'Neill, MD principal investigator
Medical College of Wisconsin
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 Medical College of Wisconsin 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 3 inclusion and 5 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 8 Oct 2026. 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?
Change in head and trunk position from centerline at baseline, 3-months and 6-months. (time frame: Through study completion, an average of 2 years). The study lists 2 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 8 Oct 2026.