Cerebral Palsy (CP)NCT06693388
WBV and Serial Casting for Children With Cerebral Palsy
A study testing Exercise, Whole-Body Vibration and Serial Casting in people with Cerebral Palsy (CP) and Cerebral Palsy, run by Ben Reader at 1 site in United States.
Trial summary
Children with cerebral palsy have increased muscle tone which often results in decreased active and passive movement at the ankle. While many management strategies exist (including passive stretching, WBV, serial casting, Botox, and surgical tendon lengthening), the utilization of WBV in combination with active… Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Cerebral Palsy (CP), Cerebral Palsy
- What is being tested?
- Exercise, Whole-Body Vibration and Serial Casting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 3-17 and 32 weeks exclusive years;
- Diagnosis of cerebral palsy;
- GMFCS levels I-III;
- Stands with upper extremity support or less support;
- Active referral from a prescribing provider for serial casting with ankle DF of <10 degrees;
- Willing to pursue care at [primary site] outpatient physical therapy clinic for the duration of the study;
- Subjects/families must be able to communicate in the English language without the need for interpreter.
Who cannot join
- History of selective dorsal rhizotomy;
- previous Achilles tendon lengthening or other orthopedic interventions to the lower extremities in 1 year prior to enrollment;
- skin, circulation, vascular conditions;
- Previous history of cancer;
- Reduced ankle/foot sensation;
- Allergies to casting materials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43228
Ben Reader, DPT, 614-722-8374, ben.reader@nationwidechildrens.org
About this study
Official title: Whole-body Vibration for Children With Cerebral Palsy Undergoing Serial Casting
Children with cerebral palsy have increased muscle tone which often results in decreased active and passive movement at the ankle. While many management strategies exist (including passive stretching, WBV, serial casting, Botox, and surgical tendon lengthening), the utilization of WBV in combination with active exercises and serial casting has not been previously explored. Serial casting is the repeated application of a fiberglass cast (such as that applied to manage stable fractures) on a scheduled (usually weekly basis) to gradually increase the range of motion at a specific joint. It is theorized that combining previously established standard of care practices may result in more rapid clinical change, and hence reduce the need for prolonged intervention; ultimately reducing healthcare costs.
- Conditions
- Cerebral Palsy (CP), Cerebral Palsy
- Being tested
- Exercise, Whole-Body Vibration, Serial Casting
- Keywords
- Serial Casting, Whole body Vibration, Cerebral Palsy, Pediatrics
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
2 minutes each exercise with 30 sec break - 4 exercises prior to serial casting
Whole-Body VibrationOther
WBV prior to serial casting
Serial CastingOther
Serial Casting as provided by standard of care
| Study group | Role | What they receive |
|---|---|---|
| Serial Casting Only | Active comparator | Not described Receives: Other: Serial Casting |
| Serial Casting + Exercise | Active comparator | Not described Receives: Other: Exercise; Other: Serial Casting |
| Serial Casting + Exercise + WBV | Active comparator | Not described Receives: Other: Exercise; Other: Whole-Body Vibration; Other: Serial Casting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle Dorsiflexion Range of Motion (Goniometer)
Measured with Goniometer in degrees. Knee flexed and knee extended.
Measured: Longitudinal through study completion, an average of 6 weeks but upto 12 weeks
Secondary outcomes (2)
Pain (Visual Analogue Scale/Wong-Baker Faces)
Wong-Baker Faces will be used for those unable to provide a visual analogue scale score. Visual Analogue Scale = 0 (no pain) - 10 (worst pain). Wong-Baker Faces = ordinal level categories of pain. Categories = 0 no hurt, 2 hurts little bit, 4 hurts little more, 6 hurts even more, 8 hurst whole lot, 10 hurts worst. On both scales, higher number will be worst outcomes.
Measured: Longitudinal through study completion, an average of 6 weeks but upto 12 weeks
Length of Casting Episode (Weeks)
Measured in weeks from the date of first serial cast application to date of last cast applied. This will be extracted from the electronic health record.
Measured: Longitudinal through study completion, an average of 6 weeks but upto 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start11 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ben Reader
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ben Reader, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693388
- Sponsor's protocol ID
- STUDY00004078
- Status last verified
- Mar 2026
- First submitted
- 12 Nov 2024
- Last updated
- 25 Mar 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-body Vibration for Children With Cerebral Palsy Undergoing Serial Casting
- ClinicalTrials.gov ID
- NCT06693388
- Acronym / sponsor ID
- STUDY00004078
- Conditions
- Cerebral Palsy (CP), Cerebral Palsy
- Keywords
- Serial Casting, Whole body Vibration, Cerebral Palsy, Pediatrics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ben ReaderUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Nov 2024 (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.
Children with cerebral palsy have increased muscle tone which often results in decreased active and passive movement at the ankle. While many management strategies exist (including passive stretching, WBV, serial casting, Botox, and surgical tendon lengthening), the utilization of WBV in combination with active exercises and serial casting has not been previously explored. Serial casting is the repeated application of a fiberglass cast (such as that applied to manage stable fractures) on a scheduled (usually weekly basis) to gradually increase the range of motion at a specific joint. It is theorized that combining previously established standard of care practices may result in more rapid clinical change, and hence reduce the need for prolonged intervention; ultimately reducing healthcare costs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Serial Casting Only | Active comparator | Other: Serial Casting |
| Serial Casting + Exercise | Active comparator | Other: Exercise, Other: Serial Casting |
| Serial Casting + Exercise + WBV | Active comparator | Other: Exercise, Other: Whole-Body Vibration, Other: Serial Casting |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Ages 3-17 and 32 weeks exclusive years;
- Diagnosis of cerebral palsy;
- GMFCS levels I-III;
- Stands with upper extremity support or less support;
- Active referral from a prescribing provider for serial casting with ankle DF of <10 degrees;
Key exclusion criteria (6 listed)
- History of selective dorsal rhizotomy;
- previous Achilles tendon lengthening or other orthopedic interventions to the lower extremities in 1 year prior to enrollment;
- skin, circulation, vascular conditions;
- Previous history of cancer;
- Reduced ankle/foot sensation;
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 |
|---|---|---|
| Exercise2 minutes each exercise with 30 sec break - 4 exercises prior to serial casting | Other | Serial Casting + Exercise, Serial Casting + Exercise + WBV |
| Whole-Body VibrationWBV prior to serial casting | Other | Serial Casting + Exercise + WBV |
| Serial CastingSerial Casting as provided by standard of care | Other | Serial Casting + Exercise, Serial Casting + Exercise + WBV, Serial Casting Only |
Primary outcome
Ankle Dorsiflexion Range of Motion (Goniometer)
Time frame: Longitudinal through study completion, an average of 6 weeks but upto 12 weeks
Measured with Goniometer in degrees. Knee flexed and knee extended.
2 secondary outcomes
Pain (Visual Analogue Scale/Wong-Baker Faces)
Time frame: Longitudinal through study completion, an average of 6 weeks but upto 12 weeks
Length of Casting Episode (Weeks)
Time frame: Longitudinal through study completion, an average of 6 weeks but upto 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Whole-Body Vibration and Serial Casting in people with Cerebral Palsy (CP) and Cerebral Palsy, run by Ben Reader 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 25 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ben Reader, DPT (614-722-8374, ben.reader@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle Dorsiflexion Range of Motion (Goniometer) (time frame: Longitudinal through study completion, an average of 6 weeks but upto 12 weeks). 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 25 Mar 2026.