Whole-Body Vibration and Serial Casting for Cerebral Palsy

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ben Reader

Must not be taking: Botox

Disqualifiers: Rhizotomy, Orthopedic interventions, Cancer, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Whole-Body Vibration and Serial Casting for Cerebral Palsy?

Research shows that serial casting can help improve lower limb function in children with cerebral palsy, and whole-body vibration therapy can enhance balance, gait, and motor function. Combining these treatments may offer benefits for managing cerebral palsy symptoms. ^{1 2 3 4 5}

Is serial casting safe for humans?

Serial casting is commonly used in children with cerebral palsy and is generally considered safe, with studies showing improvements in movement and muscle control when used with other therapies. ^{1 6 7 8 9}

How does the whole-body vibration and serial casting treatment for cerebral palsy differ from other treatments?

Whole-body vibration (WBV) is a unique treatment for cerebral palsy that involves standing on a vibrating platform to improve muscle strength, balance, and motor function. Unlike traditional physical therapy, WBV can be particularly beneficial for children with moderate impairments who have difficulty with conventional strength training exercises. ^{2 3 4 10 11}

Research Team

Eligibility Criteria

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 am between 3 and 17 years old.

Exclusion Criteria

Allergies to casting materials

Reduced ankle/foot sensation

I have had a selective dorsal rhizotomy surgery.

Trial Timeline

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

Treatment Details

Interventions

• Serial Casting (Procedure)
• Whole-Body Vibration (Behavioural Intervention)

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.

Participant Groups

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

Group II: Serial Casting Only Active Control 1 Intervention

Group III: Serial Casting + Exercise Active Control 2 Interventions

Who Is Running the Clinical Trial?

Ben Reader

Lead Sponsor

Trials

1

Recruited

50+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Use of whole body vibration therapy in individuals with moderate severity of cerebral palsy- a feasibility study. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Neuromuscular response to a single session of whole-body vibration in children with cerebral palsy: A pilot study. [2021]

4. Canada 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. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Systematic review of whole body vibration exercises in the treatment of cerebral palsy: Brief report. [2018]

6. United States 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. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Intermittent serial casting for wrist flexion deformity in children with spastic cerebral palsy: a randomized controlled trial. [2021]

8. England pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

A pilot study of delayed versus immediate serial casting after botulinum toxin injection for partially reducible spastic equinus. [2022]

10. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Effect of whole-body vibration on abdominal thickness and sitting ability in children with spastic diplegia. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

Whole-body vibration training improves the walking ability of a moderately impaired child with cerebral palsy: a case study. [2020]