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RecruitingNCT06693388Updated Mar 25, 2026

WBV and Serial Casting for Children With Cerebral Palsy

An interventional study of Exercise and Whole-Body Vibration in Cerebral Palsy (CP) and Cerebral Palsy, sponsored by Ben Reader. Recruiting at 1 site in United States. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-03-25.

Sponsored by Ben Reader · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
3 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cerebral Palsy (CP)
  • Cerebral Palsy

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Keywords

  • Serial Casting
  • Whole body Vibration
  • Cerebral Palsy
  • Pediatrics
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's planned enrollment of 45 is above the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

This is the only study on the registry with Ben Reader as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
45 participants (estimated)

Study arms

  • Active comparator
    Serial Casting Only

    Other: Serial Casting

  • Active comparator
    Serial Casting + Exercise

    Other: Exercise · Other: Serial Casting

  • Active comparator
    Serial Casting + Exercise + WBV

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

Interventions

  • OtherExercise

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

  • OtherWhole-Body Vibration

    WBV prior to serial casting

  • OtherSerial Casting

    Serial Casting as provided by standard of care

06

What researchers measure

Primary outcomes

  1. Ankle Dorsiflexion Range of Motion (Goniometer)

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

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

Other outcomes

  1. Adverse effects

    skin breakdown, early removal etc.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06693388
Lead sponsor
Ben Reader
Responsible party
Ben Reader (Research Scientist, Nationwide Children's Hospital) — Sponsor-investigator
First posted
Nov 18, 2024
Start date
Nov 11, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 25, 2026

Study contacts

Ben Reader, DPT
Contact
ben.reader@nationwidechildrens.org
614-722-8374

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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