WBV and Serial Casting for Children with Cerebral Palsy

Not Applicable

Recruiting

• Conditions: Cerebral Palsy (CP); Cerebral Palsy

• Registration Number: NCT06693388
• Lead Sponsor: Ben Reader

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-11
• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-14
• Study First Posted: 2024-11-18
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ankle Dorsiflexion Range of Motion (Goniometer)	Longitudinal through study completion, an average of 6 weeks but upto 12 weeks	Measured with Goniometer in degrees. Knee flexed and knee extended.

Secondary Outcome Measures

Name	Time	Method
Pain (Visual Analogue Scale/Wong-Baker Faces)	Longitudinal through study completion, an average of 6 weeks but upto 12 weeks	Wong-Baker Faces will be used for those unable to provide a visual analogue scale score. Visual Analogue Scale = 0 (no pain) - 10 (worst pain). Wong-Baker Faces = ordinal level categories of pain. Categories = 0 no hurt, 2 hurts little bit, 4 hurts little more, 6 hurts even more, 8 hurst whole lot, 10 hurts worst. On both scales, higher number will be worst outcomes.
Length of Casting Episode (Weeks)	Longitudinal through study completion, an average of 6 weeks but upto 12 weeks	Measured in weeks from the date of first serial cast application to date of last cast applied. This will be extracted from the electronic health record.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States