20 Participants NeededMy employer runs this trial

Treadmill Training and Whole-body Vibration for Cerebral Palsy

GH
JW
GP
Overseen ByGena Priest, PT, DPT, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether combining whole-body vibration (WBV) with treadmill training (TT) can improve walking and reduce muscle tightness in children with cerebral palsy (CP). WBV alone provides short-term benefits, so researchers aim to determine if adding TT extends these benefits. Children with spastic CP who can walk and have not experienced recent injuries or Botox treatments are suitable candidates for this trial. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could enhance treatment options for cerebral palsy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had Botox injections to the lower extremities in the past 3 months, you would not be eligible to participate.

What prior data suggests that whole-body vibration and treadmill training are safe for children with cerebral palsy?

Research shows that treadmill training is safe and effective for children with cerebral palsy (CP). Studies have found it helps improve walking distance and speed, which enhances movement. These studies report no major side effects from treadmill use, indicating it is well-tolerated.

Whole-body vibration (WBV) therapy has also been researched for children with CP. It has been shown to improve balance and reduce muscle stiffness. While WBV is generally considered safe, providers should remain aware of potential risks for children with disabilities. Overall, both treatments have proven effective and are usually well-tolerated in children with cerebral palsy.12345

Why are researchers excited about this trial?

Researchers are excited about the use of treadmill training and whole-body vibration for cerebral palsy because these techniques offer a new approach to enhancing mobility and muscle function. Unlike traditional therapies that often focus on physical exercises and muscle strengthening, treadmill training provides a controlled environment for repetitive walking practice, potentially improving gait and endurance. Whole-body vibration, on the other hand, may stimulate muscle activity and improve muscle tone, offering a complementary benefit to the treadmill training. This combination could lead to more efficient and effective improvements in motor skills for individuals with cerebral palsy.

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

Research has shown that treadmill training, a treatment in this trial, can help children with cerebral palsy improve walking and movement skills. One study found that treadmill training boosts recovery and physical responses in children with movement disorders. Similarly, whole-body vibration (WBV), another treatment option in this trial, shows promise in reducing muscle tightness and improving balance and strength in these children. Studies indicate that WBV can enhance lower limb function and prove more effective than other physical therapies. This trial will explore the potential benefits of combining these treatments to improve movement patterns and reduce muscle stiffness.12678

Who Is on the Research Team?

JW

Jianhua Wu, PhD

Principal Investigator

Georgia State University

Are You a Good Fit for This Trial?

This trial is for children aged 6-17 with spastic Cerebral Palsy who can follow instructions on a treadmill. They should be able to walk (GMFCS level I, II, or III). Kids with recent musculoskeletal injuries, Botox treatments in the legs, significant heart issues, or uncontrolled seizures cannot participate.

Inclusion Criteria

You have a Gross Motor Function Classification System (GMFCS) level of I, II, or III.
You are between 6 and 17 years old when the data is collected.
You have been diagnosed with spastic cerebral palsy.
See 3 more

Exclusion Criteria

You have trouble understanding and following instructions while walking on the treadmill.
History of significant cardiac abnormalities and/or uncontrolled seizures
You have had a muscle or bone injury in the last 3 months.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 10-minute bout of treadmill training, rest for 15 minutes, followed by a 12-minute bout of whole-body vibration, and a second 10-minute bout of treadmill training

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in gait parameters and spasticity immediately after the intervention

immediate
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Treadmill Training
  • Whole Body Vibration

Trial Overview

The study tests if adding Whole-body Vibration (WBV) to Treadmill Training (TT) helps improve walking and reduce muscle stiffness better than TT alone in kids with Cerebral Palsy. It looks at how one session of WBV might boost the benefits of a TT session.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Intervention GroupExperimental Treatment2 Interventions

Treadmill Training is already approved in China for the following indications:

🇨🇳
Approved in China as Remote Ischemic Conditioning for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials
71
Recruited
33,600+

Citations

Feasibility, Safety, and Tolerability of Remote Ischemic ... - PMC

Remote ischemic conditioning (RIC) was feasible in children with unilateral cerebral palsy (CP), with excellent recruitment, retention, and full ...

effects of ischemic conditioning along with bimanual task ...

These results show that ischemic conditioning combined with bimanual task training greatly improves motor function and task efficiency in children with UCP.

Remote Limb Ischemic Conditioning to Enhance Muscle ...

conditioning (RLIC) can enhance quadriceps muscle power, dynamic balance and walking performance in children with cerebral palsy (CP).

Comparative analysis of the beneficial effects of treadmill ...

These results suggest that treadmill training and EA stimulation contribute to the enhancement of behavioral recovery following hypoxia-ischemia ...

Remote ischaemic conditioning combined with bimanual task ...

Studies comparing the efficacy of constraint-induced movement therapy and bimanual training in children with unilateral cerebral palsy: a systematic review.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41153554/

Feasibility, Safety, and Tolerability of Remote Ischemic ...

Repeated RIC is feasible, safe, and tolerable in children with unilateral CP. These findings support the design of future trials using RIC ...

Remote Ischaemic Conditioning Combined With Bimanual ...

Expected outcomes. We predict that as compared with sham condition- ing+training, RIC+training will significantly: (1) increase cortical ...

Remote Ischemic Conditioning for Cerebral Palsy

Research has shown that Remote Ischemic Conditioning (RIC) is safe and well-tolerated in children with unilateral cerebral palsy, a movement ...