WBV and Serial Casting for Children With Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise, Whole-Body Vibration, Serial Casting.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy (CP), Cerebral Palsy. Basic parameters: 3 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Whole-body Vibration for Children With Cerebral Palsy Undergoing Serial Casting
Overview
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.
Interventions
- Other Exercise
2 minutes each exercise with 30 sec break - 4 exercises prior to serial casting - Other Whole-Body Vibration
WBV prior to serial casting - Other Serial Casting
Serial Casting as provided by standard of care
Primary outcome measures
- Ankle Dorsiflexion Range of Motion (Goniometer) [Time frame: Longitudinal through study completion, an average of 6 weeks but upto 12 weeks]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Nationwide Children's Hospital — Columbus
Identifiers
NCT: NCT06693388 · STUDY00004078