NCT00281359

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

3.4 years

First QC Date

January 23, 2006

Last Update Submit

November 4, 2014

Conditions

Cerebral Palsy

Keywords

cerebral palsydynamic splintingcontracturesheat therapy

Outcome Measures

Primary Outcomes (1)

  • Range of motion

    15 degree change in RoM

    12 weeks

Study Arms (2)

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

With heatDEVICE

heat pad followed by dynamic splinting

Also known as: heat pad followed by dynamic splinting
With heat
No heatDEVICE

No heat added to tissue prior to dynamic splinting

Without heat

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children with cerebral palsy -

You may not qualify if:

  • absent thermal sensation -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust

Oswestry, Shropshire, SY10 7AG, United Kingdom

Location

MeSH Terms

Conditions

Cerebral PalsyContractureHyperthermia

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesJoint DiseasesMusculoskeletal DiseasesMuscular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Study Officials

  • John Patrick

    Robert Jones and Agnes Hunt Orthopaedic Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2006

First Posted

January 24, 2006

Study Start

April 1, 2003

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

GB(1)