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NCT Number: NCT06693388

WBV and Serial Casting for Children With Cerebral Palsy

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.

Recruiting

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43228, United States

Location status: Recruiting

Location contact

Ben Reader, DPT

CONTACT

[email protected]

614-722-8374

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

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

Whole-Body Vibration

Other

WBV prior to serial casting

Serial Casting

Other

Serial Casting as provided by standard of care

Primary outcomes

  1. 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

  1. Pain (Visual Analogue Scale/Wong-Baker Faces)

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

    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.

  2. Length of Casting Episode (Weeks)

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

Other outcomes

  1. Adverse effects

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

    skin breakdown, early removal etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Ben Reader, DPT

CONTACT

[email protected]

614-722-8374

Sponsors and collaborators

Lead sponsor

Ben Reader

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2024
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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