Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Action Medical Research
Information provided by (Responsible Party):
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
ClinicalTrials.gov Identifier:
NCT00281359
First received: January 23, 2006
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

This study is looking at new ways to stretch knee contractures in children with cerebral palsy using a specially designed splint.


Condition Intervention
Cerebral Palsy
Device: With heat
Device: No heat

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Study of the Effectiveness of Treatment of Contractures With Mechanically Applied Stretch and Heat.

Resource links provided by NLM:


Further study details as provided by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust:

Primary Outcome Measures:
  • Range of motion [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    15 degree change in RoM


Enrollment: 20
Study Start Date: April 2003
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

children with cerebral palsy -

Exclusion Criteria:

absent thermal sensation -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281359

Locations
United Kingdom
Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Oswestry, Shropshire, United Kingdom, SY10 7AG
Sponsors and Collaborators
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Action Medical Research
Investigators
Principal Investigator: John Patrick Robert Jones and Agnes Hunt Orthopaedic Hospital
  More Information

No publications provided

Responsible Party: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
ClinicalTrials.gov Identifier: NCT00281359     History of Changes
Other Study ID Numbers: RL1 230
Study First Received: January 23, 2006
Last Updated: November 4, 2014
Health Authority: United Kingdom: Department of Health

Keywords provided by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust:
cerebral palsy
dynamic splinting
contractures
heat therapy

Additional relevant MeSH terms:
Cerebral Palsy
Contracture
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Joint Diseases
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 24, 2014