Back to resultsA Comparative Study of the Effectiveness of Treatment of Contractures With Mechanically Applied Stretch and Heat.
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
With heat
No heat
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, dynamic splinting, contractures, heat therapy
Eligibility Criteria
Inclusion Criteria: children with cerebral palsy - Exclusion Criteria: absent thermal sensation -
Sites / Locations
- Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
With heat
Without heat
Arm Description
heat applied to contracted tissues prior to using the active stretching orthosis.
No heat applied to the contracted tissues prior to using the stretching orthosis
Outcomes
Primary Outcome Measures
Range of motion
15 degree change in RoM
Secondary Outcome Measures
Full Information
NCT ID
NCT00281359
First Posted
January 23, 2006
Last Updated
November 4, 2014
Sponsor
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Collaborators
Action Medical Research
1. Study Identification
Unique Protocol Identification Number
NCT00281359
Brief Title
A Comparative Study of the Effectiveness of Treatment of Contractures With Mechanically Applied Stretch and Heat.
Official Title
A Comparative Study of the Effectiveness of Treatment of Contractures With Mechanically Applied Stretch and Heat.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Collaborators
Action Medical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is looking at new ways to stretch knee contractures in children with cerebral palsy using a specially designed splint.
Detailed Description
When using active orthoses to treat contractures, is the effectiveness of treatment improved by heating the contracted tissue prior to treatment?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, dynamic splinting, contractures, heat therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
With heat
Arm Type
Experimental
Arm Description
heat applied to contracted tissues prior to using the active stretching orthosis.
Arm Title
Without heat
Arm Type
Placebo Comparator
Arm Description
No heat applied to the contracted tissues prior to using the stretching orthosis
Intervention Type
Device
Intervention Name(s)
With heat
Other Intervention Name(s)
heat pad followed by dynamic splinting
Intervention Description
heat pad followed by dynamic splinting
Intervention Type
Device
Intervention Name(s)
No heat
Intervention Description
No heat added to tissue prior to dynamic splinting
Primary Outcome Measure Information:
Title
Range of motion
Description
15 degree change in RoM
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children with cerebral palsy -
Exclusion Criteria:
absent thermal sensation -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Patrick
Organizational Affiliation
Robert Jones and Agnes Hunt Orthopaedic Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
City
Oswestry
State/Province
Shropshire
ZIP/Postal Code
SY10 7AG
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Comparative Study of the Effectiveness of Treatment of Contractures With Mechanically Applied Stretch and Heat.
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