A Comparative Study of the Effectiveness of Treatment of Contractures With Mechanically Applied Stretch and Heat.

November 4, 2014 updated by: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
This study is looking at new ways to stretch knee contractures in children with cerebral palsy using a specially designed splint.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

When using active orthoses to treat contractures, is the effectiveness of treatment improved by heating the contracted tissue prior to treatment?

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Shropshire
      • Oswestry, Shropshire, United Kingdom, SY10 7AG
        • Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

children with cerebral palsy -

Exclusion Criteria:

absent thermal sensation -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With heat
heat applied to contracted tissues prior to using the active stretching orthosis.
Device: With heat
heat pad followed by dynamic splinting
Other Names:
  • heat pad followed by dynamic splinting
Placebo Comparator: Without heat
No heat applied to the contracted tissues prior to using the stretching orthosis
Device: No heat
No heat added to tissue prior to dynamic splinting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion
Time Frame: 12 weeks
15 degree change in RoM
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Collaborators

Action Medical Research

Investigators

  • Principal Investigator: John Patrick, Robert Jones and Agnes Hunt Orthopaedic Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

January 23, 2006

First Submitted That Met QC Criteria

January 23, 2006

First Posted (Estimate)

January 24, 2006

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RL1 230

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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