WBV and Serial Casting for Children with Cerebral Palsy

Ben Reader

Status: Enrolling

Conditions: Cerebral Palsy; Cerebral Palsy (CP)

Treatments: Other: Whole-Body Vibration; Other: Exercise; Other: Serial Casting

Study type: Interventional

Funder types: Other

Identifiers

NCT06693388

STUDY00004078

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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;
• No Botox or changes in oral medication to reduce spasticity within 6 months prior to enrollment;
• skin, circulation, vascular conditions;
• Previous history of cancer;
• Reduced ankle/foot sensation;
• Allergies to casting materials.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Serial Casting Only

Active Comparator group

Treatment:

Other: Serial Casting

Serial Casting + Exercise

Active Comparator group

Treatment:

Other: Serial Casting

Other: Exercise

Serial Casting + Exercise + WBV

Active Comparator group

Treatment:

Other: Serial Casting

Other: Exercise

Other: Whole-Body Vibration