WBV and Serial Casting for Children With Cerebral Palsy

Whole-body Vibration for Children With Cerebral Palsy Undergoing Serial Casting

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Cerebral Palsy (CP)
• Intervention / Treatment: Other: Serial Casting; Other: Exercise; Other: Whole-Body Vibration

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ben Reader, DPT; Phone Number: 614-722-8374; Email: ben.reader@nationwidechildrens.org

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43228
      • Recruiting
      • Nationwide Children's Hospital
      • Contact: Ben Reader, DPT; Phone Number: 614-722-8374; Email: ben.reader@nationwidechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Serial Casting Only	Other: Serial Casting; Serial Casting as provided by standard of care
Active Comparator: Serial Casting + Exercise	Other: Serial Casting; Serial Casting as provided by standard of care; Other: Exercise; 2 minutes each exercise with 30 sec break - 4 exercises prior to serial casting
Active Comparator: Serial Casting + Exercise + WBV	Other: Serial Casting; Serial Casting as provided by standard of care; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain (Visual Analogue Scale/Wong-Baker Faces)	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.	Longitudinal through study completion, an average of 6 weeks but upto 12 weeks
Length of Casting Episode (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.	Longitudinal through study completion, an average of 6 weeks but upto 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	skin breakdown, early removal etc.	Longitudinal through study completion, an average of 6 weeks but upto 12 weeks

Collaborators and Investigators

• Sponsor: Ben Reader

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Pediatrics; Whole body Vibration; Serial Casting
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: STUDY00004078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No