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Clinical Trials/NCT06693388
NCT06693388
Recruiting
Not Applicable

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

Ben Reader1 site in 1 country45 target enrollmentNovember 11, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy (CP)
Sponsor
Ben Reader
Enrollment
45
Locations
1
Primary Endpoint
Ankle Dorsiflexion Range of Motion (Goniometer)
Status
Recruiting
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 11, 2024
End Date
December 31, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ben Reader
Responsible Party
Sponsor Investigator
Principal Investigator

Ben Reader

Research Scientist

Nationwide Children's Hospital

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;
  • skin, circulation, vascular conditions;
  • Previous history of cancer;
  • Reduced ankle/foot sensation;
  • Allergies to casting materials.

Outcomes

Primary Outcomes

Ankle Dorsiflexion Range of Motion (Goniometer)

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

Measured with Goniometer in degrees. Knee flexed and knee extended.

Secondary Outcomes

  • 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)

Study Sites (1)

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