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

NCT ID: NCT00281359

Last Updated: 2014-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-09-30

Brief Summary

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

Detailed Description

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

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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With heat

heat applied to contracted tissues prior to using the active stretching orthosis.

Group Type EXPERIMENTAL

With heat

Intervention Type DEVICE

heat pad followed by dynamic splinting

Without heat

No heat applied to the contracted tissues prior to using the stretching orthosis

Group Type PLACEBO_COMPARATOR

No heat

Intervention Type DEVICE

No heat added to tissue prior to dynamic splinting

Interventions

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With heat

heat pad followed by dynamic splinting

Intervention Type DEVICE

No heat

No heat added to tissue prior to dynamic splinting

Intervention Type DEVICE

Other Intervention Names

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heat pad followed by dynamic splinting

Eligibility Criteria

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Inclusion Criteria

children with cerebral palsy -

Exclusion Criteria

absent thermal sensation -
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Action Medical Research

OTHER

Sponsor Role collaborator

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Patrick

Role: PRINCIPAL_INVESTIGATOR

Robert Jones and Agnes Hunt Orthopaedic Hospital

Locations

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Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust

Oswestry, Shropshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RL1 230

Identifier Type: -

Identifier Source: org_study_id

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