Vibration Therapy for Cerebral Palsy

Overseen By Sydni V Wilhoite, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Georgia

Must not be taking: Bisphosphonates

Disqualifiers: Fractures, Surgery, Athetoid CP, others

Compensation: Varies

Number of Visits: 8

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how low-magnitude vibration therapy might help children with spastic cerebral palsy improve muscle strength, physical activity, and balance. Participants will stand on a special vibration platform for 10 minutes daily for 6 months, while others will use a placebo platform that doesn't vibrate. Ideal candidates are children who can walk independently and have spastic cerebral palsy. The research aims to find new ways to enhance daily life for these children. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could significantly improve the quality of life for children with spastic cerebral palsy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking bisphosphonates.

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

Research has shown that vibration therapy is generally safe for children with cerebral palsy. Some studies have found that whole-body vibration (WBV) therapy can improve walking, balance, and muscle strength. This treatment is considered efficient and can positively impact mobility and overall quality of life.

However, like any treatment, possible risks exist. One report advised caution, especially with children who have disabilities. Despite these concerns, many studies have tested the therapy, and it is usually well-tolerated.

Overall, current research suggests that vibration therapy could be a safe option with potential benefits, but monitoring for any side effects during treatment is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for cerebral palsy, which often involve physical therapy, medications, or even surgery, vibration therapy uses a unique delivery method that involves standing on a gently vibrating platform. This non-invasive approach may help improve muscle function and coordination by stimulating the body's proprioceptive system, which is responsible for balance and spatial orientation. Researchers are excited about this therapy because it offers a novel, potentially low-risk way to enhance mobility and quality of life for individuals with cerebral palsy without the side effects associated with drugs or the recovery time of surgical procedures.

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

Research has shown that whole-body vibration (WBV) can help children with cerebral palsy improve muscle strength and balance. In this trial, participants will join either a Vibration Platform group or a Placebo Platform group. One study found that WBV exercises improved balance and muscle strength more effectively than other treatments. Another study confirmed that vibration therapy helped young children move better, improved muscle function, and enhanced overall quality of life. Additionally, WBV has reduced leg stiffness, a common issue in cerebral palsy. Overall, evidence suggests that WBV can be a helpful treatment for improving physical abilities in children with this condition. ^{1 2 4 6 7}

Who Is on the Research Team?

Christopher M Modlesky, PhD

Principal Investigator

University of Georgia

Are You a Good Fit for This Trial?

This trial is for children with spastic cerebral palsy who can walk on their own without help. They shouldn't have had certain treatments like Botox in the past year, be taking specific bone medications, or have a Baclofen pump. Also, they must not have had recent leg surgery or fractures in both femurs or tibias.

Inclusion Criteria

You can walk without help or devices.

You have spastic cerebral palsy.

Exclusion Criteria

Children with only athetoid cerebral palsy.

You are currently using bisphosphonates.

You cannot stand on your own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants stand on a vibration or placebo platform for 10 minutes per day for 6 months

6 months

Baseline, 1 month, 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment with no treatment follow-up

6 months

7 months, 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Platform
• Vibration Platform

Trial Overview The study tests if standing on a vibration platform for six months can improve muscle condition, physical activity, and balance compared to a placebo platform. After the initial period, there's another six months where no treatment is given to see lasting effects.

How Is the Trial Designed?

Group I: Vibration Platform Experimental Treatment 1 Intervention

The vibration group will stand on a platform that emits a mild vibration 10 minutes per day for 6 months. There will also be a 6 month no-treatment period.

Group II: Placebo Platform Placebo Group 1 Intervention

The placebo group will stand on a placebo platform 10 minutes per day for 6 months. There will also be a 6 month no-treatment period.

Who Is Running the Clinical Trial?

University of Georgia

Lead Sponsor

Trials

109

Recruited

43,500+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10695530/

Effectiveness of whole-body vibration in patients with cerebral ... The results suggest that WBV exercises were relatively more effective for balance and muscle strength than the other goals in cerebral palsy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4593045/

Whole body vibration and cerebral palsy: a systematic review Whole body vibration may improve spasticity, muscle strength and coordination. There is a lack of research to conclusively determine whether it does alter bone ...

3. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/s12887-022-03786-1

Vibration therapy in young children with mild to moderate ... The study confirms that side-alternating VT has positive effects on mobility, gross motor function, body composition, muscle function, and quality of life.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04087330

Whole-body Vibration in Spastic Hemiplegic Cerebral ... Whole body vibration has shown to be effective in reducing lower limb spasticity after first application of WBV with a vibration frequency of 12 Hz to 18 Hz ( 2 ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0282604

The effect of whole-body vibration on lower extremity function ... WBV training is more effective than other types of conventional physical therapy in improving the lower limb motor function of children with cerebral palsy.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2590109523000605

Whole Body Vibration Therapy for Children with Disabilities The purpose of this report is to remind providers of the potential risks of Whole Body Vibration Therapy (WBVT) for children with disabilities.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0960896622006009

Feasibility, safety, and efficacy of 12-week side-to- ... This pilot study explored the feasibility and effectiveness of vibration therapy (VT) on muscle and bone health, motor performance, and respiratory function