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WBV and Serial Casting for Children With Cerebral Palsy

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06693388
Enrollment
45
Registered
2024-11-18
Start date
2024-11-11
Completion date
2026-12-31
Last updated
2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy (CP), Cerebral Palsy

Keywords

Serial Casting, Whole body Vibration, Cerebral Palsy, Pediatrics

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.

Interventions

OTHERExercise

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

WBV prior to serial casting

Serial Casting as provided by standard of care

Sponsors

Ben Reader
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 17 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Ankle Dorsiflexion Range of Motion (Goniometer)Longitudinal through study completion, an average of 6 weeks but upto 12 weeksMeasured with Goniometer in degrees. Knee flexed and knee extended.

Secondary

MeasureTime frameDescription
Pain (Visual Analogue Scale/Wong-Baker Faces)Longitudinal through study completion, an average of 6 weeks but upto 12 weeksWong-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.
Length of Casting Episode (Weeks)Longitudinal through study completion, an average of 6 weeks but upto 12 weeksMeasured 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.

Countries

United States

Contacts

CONTACTBen Reader, DPT
ben.reader@nationwidechildrens.org614-722-8374

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026