Efficacy of Leg Casts With Heel Off-loaded in Children

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-09-30

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.

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Detailed Description

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Conditions

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Orthopedic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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splint

Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.

Group Type EXPERIMENTAL

custom made splint

Intervention Type DEVICE

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.

standard care

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

Group Type ACTIVE_COMPARATOR

standard off-load plaster cast

Intervention Type OTHER

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

Interventions

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custom made splint

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.

Intervention Type DEVICE

standard off-load plaster cast

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

Intervention Type OTHER

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No