Recruiting

WBV & Serial Casting

Sponsor:

Ben Reader

Code:

NCT06693388

Conditions

Cerebral Palsy (CP)

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

Interventions

Exercise

Whole-Body Vibration

Serial Casting

Study Details

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 ID

NCT06693388

Start date

Nov 11, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Serial Casting Only

active comparator: Serial Casting + Exercise

active comparator: Serial Casting + Exercise + WBV

Interventions

Exercise

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

Whole-Body Vibration

WBV prior to serial casting

Serial Casting

Serial Casting as provided by standard of care

Primary outcome measure

  • Ankle Dorsiflexion Range of Motion (Goniometer) [ Time Frame: Longitudinal through study completion, an average of 6 weeks but upto 12 weeks ]

Central Contacts and Locations

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43228

Contacts

More Information

Sponsor

Ben Reader

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

  • Serial Casting
  • Whole body Vibration
  • Cerebral Palsy
  • Pediatrics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ben Reader on 2026-03-25.