WBV and Serial Casting for Children with Cerebral Palsy

NCT ID: NCT06693388

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-11
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Serial Casting Only

Group Type: ACTIVE_COMPARATOR

Serial Casting

Intervention Type: OTHER

Serial Casting as provided by standard of care

Serial Casting + Exercise

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

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

Serial Casting

Intervention Type: OTHER

Serial Casting as provided by standard of care

Serial Casting + Exercise + WBV

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

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

Whole-Body Vibration

Intervention Type: OTHER

WBV prior to serial casting

Serial Casting

Intervention Type: OTHER

Serial Casting as provided by standard of care

Interventions

Exercise

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

Intervention Type: OTHER

Whole-Body Vibration

WBV prior to serial casting

Intervention Type: OTHER

Serial Casting

Serial Casting as provided by standard of care

Intervention Type: OTHER

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;
• 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ben Reader

OTHER

Sponsor Role: lead

Responsible Party

Ben Reader

Research Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ben Reader, DPT

Role: CONTACT

ben.reader@nationwidechildrens.org

614-722-8374

Facility Contacts

Ben Reader, DPT

Role: primary

ben.reader@nationwidechildrens.org

614-722-8374

Other Identifiers

STUDY00004078

Identifier Type: -

Identifier Source: org_study_id