A Comparative Study of the Effectiveness of Treatment of... | NCT00281359

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

NCT00281359

Sponsor

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Status

Completed

Last Update Posted

Nov 5, 2014Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Cerebral Palsy

Interventions

With heat
No heat

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Sep 2006Actual

Completion Date

Sep 2006Actual

First Submitted Date

Jan 23, 2006

First Submission Date that Met QC Criteria

Jan 23, 2006

First Posted Date

Jan 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2014

Last Update Posted Date

Nov 5, 2014Estimated

Name	Class
Action Medical Research	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With heat	Experimental	heat applied to contracted tissues prior to using the active stretching orthosis.	Device: With heat
Without heat	Placebo Comparator	No heat applied to the contracted tissues prior to using the stretching orthosis	Device: No heat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
With heat	Device	heat pad followed by dynamic splinting	With heat

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children with cerebral palsy -

Exclusion Criteria:

absent thermal sensation -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Patrick	Robert Jones and Agnes Hunt Orthopaedic Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust		Oswestry	Shropshire	SY10 7AG	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy
D003286	Contracture
D000084462	Hyperthermia

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided