Back to resultsEfficacy of Leg Casts With Heel Off-loaded in Children
Primary Purpose
Orthopedic Disorders
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
custom made splint
standard off-load plaster cast
Sponsored by
About this trial
This is an interventional supportive care trial for Orthopedic Disorders
Eligibility Criteria
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
Sites / Locations
- Istituto Ortopedico Rizzoli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
splint
standard care
Arm Description
Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
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
Full Information
NCT ID
NCT02468154
First Posted
November 24, 2014
Last Updated
April 12, 2016
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT02468154
Brief Title
Efficacy of Leg Casts With Heel Off-loaded in Children
Official Title
Efficacy of Leg Casts With Heel Off-loaded in Children: Open Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
splint
Arm Type
Experimental
Arm Description
Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.
Arm Title
standard care
Arm Type
Active Comparator
Arm Description
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
Device
Intervention Name(s)
custom made splint
Intervention Description
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
Other
Intervention Name(s)
standard off-load plaster cast
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain Score on the "Numeric Rating Scale" or "Visual Rating Scale" or "Face, Legs Activity Cry Consolability" According to Age Group
Description
All scales had values from 0 to 10 where zero represented no pain and 10 the worst possible pain
Time Frame
up to the first 2 days during hospitalization and at cast removal (maximum 30 days).
Secondary Outcome Measure Information:
Title
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.
Time Frame
one time at cast removal (expected average of 30 days).
Title
Health Staff/Caregiver Interventions
Description
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
Time Frame
up to the first 2 days during hospitalization
Title
Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10
Description
The scales had values from 0 to 10 where zero represented no comfort perceived and 10 the best comfort perceived
Time Frame
one time at cast removal (expected average of 30 days).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luisa Veronesi, RN
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
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Efficacy of Leg Casts With Heel Off-loaded in Children
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