Whole-Body Vibration and Serial Casting for Cerebral Palsy

Overseen By Ben Reader, DPT

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Ben Reader

Must not be taking: Botox

Disqualifiers: Rhizotomy, Orthopedic interventions, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-12 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help children with cerebral palsy improve ankle movement. Researchers are testing the effects of whole-body vibration—a technique that uses vibrations to stimulate muscles—alongside traditional methods like exercises and serial casting, which involves repeatedly applying casts to improve joint movement. The goal is to determine if this combination speeds up progress and reduces treatment time and costs. Children aged 3 to 17 with cerebral palsy who have difficulty moving their ankles may be suitable candidates for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance future treatment options for cerebral palsy.

Will I have to stop taking my current medications?

The trial requires that there be no changes in oral medication to reduce spasticity within 6 months prior to enrollment, so you may need to maintain your current medication regimen.

What prior data suggests that this protocol is safe for children with cerebral palsy?

Research has shown that serial casting is generally safe for children with cerebral palsy, improving joint movement and managing muscle tightness, known as spasticity. One study found that serial casting can be a cost-effective and safe way to manage tight muscles, though methods may vary.

For whole-body vibration (WBV), studies indicate it can enhance balance and movement in children with cerebral palsy. Importantly, no serious side effects have been reported. However, caution is advised, as risks may exist for children with other disabilities. Overall, both treatments have been well-tolerated in various settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative techniques for managing cerebral palsy. Unlike traditional therapies such as physical therapy alone, this trial combines serial casting, a method that helps improve muscle and joint alignment, with whole-body vibration (WBV), known for its potential to enhance muscle strength and balance. By integrating WBV with conventional exercises and casting, this approach could offer a more comprehensive and effective way to improve mobility and function in those with cerebral palsy. The trial aims to provide insights into whether these combined methods can deliver faster or more significant improvements compared to standard treatments, potentially transforming care for individuals with this condition.

What evidence suggests that this trial's treatments could be effective for cerebral palsy?

Research has shown that serial casting, one of the treatments in this trial, can help children with cerebral palsy improve ankle movement by gently stretching stiff muscles. In this trial, some participants will receive serial casting alone, while others will receive it combined with exercise. Studies also indicate that combining serial casting with therapy can accelerate improvements in movement skills for children.

Whole-body vibration (WBV), another treatment option in this trial, has been found to enhance balance and walking in people with cerebral palsy. It can be more effective than some traditional therapies for improving leg function. In this trial, some participants will receive a combination of serial casting, exercise, and WBV. Adding WBV to exercise programs can further enhance motor skills. These findings suggest that using both serial casting and WBV together could be a promising treatment for children with cerebral palsy. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children with cerebral palsy who have increased muscle tone leading to limited movement in their ankles. It's not clear what specific age range or other health conditions might be included or excluded.

Inclusion Criteria

I (or my family) can communicate in English without an interpreter.

I am willing to attend all therapy sessions at the specified clinic for the study period.

I can walk with or without limitations.

Exclusion Criteria

Reduced ankle/foot sensation

Allergies to casting materials

I have skin or blood circulation issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo serial casting, with or without whole-body vibration and exercises, to improve ankle range of motion

6-12 weeks

Weekly visits for casting

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Serial Casting
• Whole-Body Vibration

Trial Overview The study is testing a new treatment approach that combines whole-body vibration (WBV) and active exercises with serial casting, which involves applying casts regularly to improve ankle motion.

How Is the Trial Designed?

Group I: Serial Casting + Exercise + WBV Active Control 3 Interventions

Group II: Serial Casting + Exercise Active Control 2 Interventions

Group III: Serial Casting Only Active Control 1 Intervention

Who Is Running the Clinical Trial?

Ben Reader

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

A single session of whole-body vibration (WBV) significantly reduced spasticity and improved motor function in children with cerebral palsy, regardless of whether a low (1 mm) or high (2 mm) amplitude was used.

Both WBV amplitudes enhanced postural control and gait patterns, with high-amplitude WBV further increasing ankle range of motion, suggesting that low-amplitude WBV can be an effective alternative for children who may not tolerate stronger vibrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular response to a single session of whole-body vibration in children with cerebral palsy: A pilot study. Liang, V., Henderson, G., Wu, J.[2021]

Whole-body vibration (WBV) training significantly improved ankle joint-position sense in children with cerebral palsy after just 3 weeks of treatment.

Children receiving WBV in addition to conventional physical therapy showed greater improvements in gait speed and step width compared to those who only received conventional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Three Weeks of Whole-Body Vibration Training on Joint-Position Sense, Balance, and Gait in Children with Cerebral Palsy: A Randomized Controlled Study. Ko, MS., Sim, YJ., Kim, DH., et al.[2019]

Whole-body vibration training was found to be an effective method for strengthening in an 8-year-old boy with cerebral palsy who required crutches for walking, showing improvements in gross motor function after 5 weeks of therapy.

The training led to a reduction in spasticity and improved crutch-walking ability, as evidenced by better performance in a 5-meter walk test, indicating its potential as a beneficial intervention for moderately impaired children with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-body vibration training improves the walking ability of a moderately impaired child with cerebral palsy: a case study. Yabumoto, T., Shin, S., Watanabe, T., et al.[2020]

Whole body vibration therapy (WBVT) was found to be feasible and well-tolerated in a pilot study involving 14 participants with moderate cerebral palsy, with a high attendance rate of over 90% and no adverse events reported.

The study suggests that WBVT could be a safe intervention for individuals with moderate severity of cerebral palsy, warranting further research with larger sample sizes and more rigorous designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of whole body vibration therapy in individuals with moderate severity of cerebral palsy- a feasibility study. Pin, TW., Butler, PB., Purves, S.[2020]

A 12-week whole-body vibration (WBV) intervention significantly improved abdominal muscle thickness in children with spastic diplegic cerebral palsy, with notable increases in all four abdominal muscle types measured.

Children receiving WBV training also demonstrated greater improvements in sitting ability compared to those who only received standard physical therapy, indicating that WBV can enhance motor function in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of whole-body vibration on abdominal thickness and sitting ability in children with spastic diplegia. Ali, MS., Abd El-Aziz, HG.[2022]

In a study involving 80 children with cerebral palsy, combining serial casting with botulinum toxin type A injections led to significant improvements in muscle tone and motor function compared to botulinum toxin treatment alone.

The serial casting group showed enhanced benefits, particularly in muscle spasticity as measured by the modified Ashworth scale, indicating that this combination therapy may be more effective for managing scissoring of the legs in these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serial Casting as an Adjunct to Botulinum Toxin Type A Treatment in Children With Cerebral Palsy and Spastic Paraparesis With Scissoring of the Lower Extremities. Dai, AI., Demiryürek, AT.[2018]

Serial casting is an effective treatment for spasticity, as it can improve range of motion and reduce clinical measures of spasticity in affected limbs.

The review highlights the need for further research to optimize the application of serial casting in treating spasticity, indicating that while it shows promise, more studies are necessary to establish best practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of serial casting on spasticity: a literature review. Preissner, KS.[2013]

Delaying serial casting for 4 weeks after botulinum toxin injections resulted in a greater improvement in dorsiflexion angle (27 degrees) compared to immediate casting (17 degrees) at 3 months, indicating enhanced efficacy of the delayed approach.

The delayed casting group experienced fewer painful episodes related to casting, suggesting that this method may not only improve outcomes but also enhance patient comfort and potentially reduce the need for more frequent botulinum toxin reinjections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of delayed versus immediate serial casting after botulinum toxin injection for partially reducible spastic equinus. Newman, CJ., Kennedy, A., Walsh, M., et al.[2022]

Whole body vibration (WBV) shows weak evidence for improving muscle strength and gait in individuals with cerebral palsy, based on a systematic review of five studies, but the results are inconclusive due to design limitations and poorly described intervention protocols.

There is currently no evidence that WBV can reduce spasticity in this population, highlighting the need for larger, more controlled studies to better understand the potential benefits of WBV on mobility, strength, and bone mineral density.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of whole body vibration exercises in the treatment of cerebral palsy: Brief report. Sá-Caputo, DC., Costa-Cavalcanti, R., Carvalho-Lima, RP., et al.[2018]

A systematic review of 25 studies involving children with Cerebral Palsy found that lower limb serial casting effectively improves ankle dorsiflexion range of motion, reduces hypertonicity, and enhances functional gait outcomes in the short to mid-term.

While serial casting combined with botulinum toxin type-A showed greater improvements in ankle dorsiflexion compared to casting alone, it did not significantly impact overall gross motor function, indicating that while beneficial, the clinical significance of the additional improvement may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of serial casting on lower limb function for children with Cerebral Palsy: a systematic review with meta-analysis. Milne, N., Miao, M., Beattie, E.[2021]

In a study of 34 children with cerebral palsy, those receiving intermittent serial casting along with botulinum neurotoxin A (BoNT-A) and occupational therapy showed significantly greater improvements in passive range of motion and muscle tone compared to the control group.

The results suggest that intermittent serial casting can be an effective complementary treatment for enhancing the benefits of BoNT-A and occupational therapy in children with spastic wrist flexion deformity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent serial casting for wrist flexion deformity in children with spastic cerebral palsy: a randomized controlled trial. Dursun, N., Gokbel, T., Akarsu, M., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7330971/

The effects of serial casting on lower limb function for children ... Serial casting was found to be effective for: Improving ankle dorsiflexion (DF) passive range of motion (PROM) in the immediate to short-term, decreasing ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0976566211600362

Efficacy of occupational therapy and serial casting in lower ... Serial casting when combined with occupational therapy after phenol block gives much better and quicker improvement in gross motor function and motor milestone ...

3. canchild.ca canchild.ca/resources/82-serial-casting-in-the-upper-extremity-of-children-with-cerebral-palsy/

Serial Casting in the Upper Extremity of Children with ... The current research suggests that serial casting may be an effective modality for lengthening muscles affected by spasticity in children with CP. Although this ...

4. ccm-resources.com ccm-resources.com/wp-content/uploads/2021/04/12-Dursun-Am-J-Phys-Med-Rehabil.pdf

Randomized Controlled Trial on Effectiveness of Intermittent ... 7 reported less painful episodes and better spasticity measurements at 3- and 6-month follow-ups with a combined treatment of delayed casting than immediate.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/dmcn.14765

Intermittent serial casting for wrist flexion deformity in ... Intermittent serial casting is a useful treatment option in children with cerebral palsy with spastic wrist flexion deformity.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06693388

WBV and Serial Casting for Children with Cerebral Palsy A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

7. mdpi.com mdpi.com/2076-3425/14/10/1000

A Pilot Study Comparing Orthoses and Barefoot Conditions Interventions like serial casting are commonly used to improve joint mobility and manage spasticity in children with CP.

8. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1502495/full

Serial casting for contractures in SMA: consensus derived ... While serial casting is cost-effective and safe for managing contractures, given the lack of direct evidence and standardization of procedures ...