WBV and Serial Casting for Children With Cerebral Palsy

NCT06693388 | Recruiting

• 1 other identifier: STUDY00004078
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy (CP); Cerebral Palsy

Keywords

Serial Casting; Whole body Vibration; Cerebral Palsy; Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain (Visual Analogue Scale/Wong-Baker Faces)

  Longitudinal through study completion, an average of 6 weeks but upto 12 weeks

• Length of Casting Episode (Weeks)

  Longitudinal through study completion, an average of 6 weeks but upto 12 weeks

Other Outcomes (1)

• Adverse effects

  Longitudinal through study completion, an average of 6 weeks but upto 12 weeks

Study Arms (3)

Serial Casting Only

ACTIVE COMPARATOR

Other: Serial Casting

Serial Casting + Exercise

ACTIVE COMPARATOR

Other: Exercise; Other: Serial Casting

Serial Casting + Exercise + WBV

ACTIVE COMPARATOR

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

Interventions

Exercise OTHER

2 minutes each exercise with 30 sec break - 4 exercises prior to serial casting

Serial Casting + Exercise; Serial Casting + Exercise + WBV

Whole-Body Vibration OTHER

WBV prior to serial casting

Serial Casting + Exercise + WBV

Serial Casting OTHER

Serial Casting as provided by standard of care

Serial Casting + Exercise; Serial Casting + Exercise + WBV; Serial Casting Only

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ben Reader: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43228, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ben Reader, DPT

CONTACT

614-722-8374; ben.reader@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 18, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)