Efficacy of Leg Casts With Heel Off-loaded in Children

NCT02468154 | Completed Results

• 1 other identifier: 79/14
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthopedic Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  up to the first 2 days during hospitalization

• Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10

  one time at cast removal (expected average of 30 days).

Study Arms (2)

splint

EXPERIMENTAL

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

Device: custom made splint

standard care

ACTIVE COMPARATOR

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

Interventions

custom made splint 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.

splint

standard off-load plaster cast 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

standard care

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Results Point of Contact

• Title: Luisa Veronesi
• Organization: Istituto Ortopedico Rizzoli

cristiana.forni@ior.it

0516366694

Study Officials

• Luisa Veronesi, RN

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: June 10, 2015
• Study Start: November 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 18, 2016
• Results First Posted: May 18, 2016

Record last verified: 2015-09

Locations

IT (1)