Efficacy of Leg Casts With Heel Off-loaded in Children

Study Overview
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Brief Summary
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Assess whether by placing a custom made splint with heel in the immediate postoperative period until removal of the cast, the rate of pain, the number of healthcare interventions to maintain the off-loaded heel position and number of pressure sores in children wearing lower limb plaster casts is reduced.

Official Title
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Efficacy of Leg Casts With Heel Off-loaded in Children: Open Randomized Controlled Trial

Conditions
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Orthopedic Disorders

Intervention / Treatment
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* Device: custom made splint
* Other: standard off-load plaster cast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treated by operations to the lower limbs which require immediate plaster casts that include the foot Treated by osteotomy, joint fusion, patella repositioning and fracture fixation Children with intact skin at the heel Exclusion Criteria: Caregivers who cannot speak Italian Those who refuse to give their consent to take part in the study Patients with lower limb casts that are allowed to load the limb

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: splint<br>Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded. | Device: custom made splint<br>* Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs.<br>|
| Active Comparator: standard care<br>To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane | Other: standard off-load plaster cast<br>* To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score on the Numeric Rating Scale or Visual Rating Scale or Face, Legs Activity Cry Consolability According to Age Group | All scales had values from 0 to 10 where zero represented no pain and 10 the worst possible pain | up to the first 2 days during hospitalization and at cast removal (maximum 30 days). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of Participants With Heel Pressure Sores Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P. |  | one time at cast removal (expected average of 30 days). | 
| Health Staff/Caregiver Interventions | daily number of interventions by health staff /caregiver to maintain the cast in an off-loaded position, marked on a form given daily to the family/caregiver | up to the first 2 days during hospitalization | 
| Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10 | The scales had values from 0 to 10 where zero represented no comfort perceived and 10 the best comfort perceived | one time at cast removal (expected average of 30 days). |