Comparison of Tendon Transfer, Botox Injections and Ongoing Treatment in Hemiplegic Cerebral Palsy (UECP)

November 18, 2014 updated by: Michelle James, Shriners Hospitals for Children

Multi Center Project: Comparison of Functional Outcomes of Tendon Transfer Surgery, Botulinum Toxin Injections and Regular Ongoing Treatment in Hemiplegic Upper Extremity Cerebral Palsy

Doctors use different treatments for people with Cerebral Palsy. Surgery is one option. Botulinum toxin injections are another option; these are given directly into spastic muscles to weaken them temporarily. Regular ongoing treatment (splinting, stretching and exercises) is another option. The investigators want to find out if surgery works better than Botulinum Toxin (Botox) injections or regular ongoing treatment (therapy), and if the effects of Botulinum Toxin injections last for longer than six months.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The specific aims of this study and the methodology for achieving them are:

  1. To determine if tendon surgery for the forearm, wrist and thumb deformities of UECP is more effective than Botulinum toxin injections or regular ongoing treatment at improving function and quality of life for children with UECP. Children who are candidates for tendon surgery will be prospectively randomized to one of three treatment groups: standard tendon surgery, a series of three Botulinum toxin injections over a period of 12 months, and regular ongoing treatment. Validated tests of cognition, function and quality of life with tests of stereognosis and range of motion will be administered before, during and after treatment in order to compare outcomes of the three treatment groups.
  2. To determine if serial Botulinum toxin injections have long-term beneficial effects on upper extremity function which outlast their paralytic effects.

Botulinum toxin has been shown to have beneficial effects on UE function while the muscles injected remain weakened by the toxin. Clinicians have theorized that improvements in UE function are maintained after the toxin wears off, but this has not been proven. Children randomized to the Botulinum toxin injection group will receive 3 injections. Their function will be tested before the first injection, while the paralytic results of the second injection are still in effect, and after the paralytic effects of the third injection have worn off, and the results compared in order to determine if functional improvements outlast the medicinal effects.

Study Type

Interventional

Enrollment (Actual)

38

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 States
    • California
      • Sacramento, California, United States, 95817
        • Shriners Hospitals For Children Northern California
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Alfred I duPont Childrens Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2970
        • Children's National Medical Center
    • Florida
      • Tampa, Florida, United States, 33612
        • Shriners Hosptials for Children
    • Illinois
      • Chicago, Illinois, United States, 60707
        • Shriners Hospitals for Children Chicago
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Shriners Hospitals for Children
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • Shriners Hospitals for Children, Twin Cities
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Shriners Hospitals for Children
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • Shriners Hosptials for Children, Intermountain

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

4 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of UECP
  • aged four to 17 years
  • candidate for standard surgical management (tendon transfer)

Exclusion Criteria:

  • subject could benefit from procedures in addition to standard surgical management and releases, and these procedures could be performed at the same anesthetic (for example, elbow flexor release)
  • previous Botulinum toxin injection session in the affected UE in < 1 year
  • previous ipsilateral UE surgery
  • primary language other than English or Spanish
  • subject and/or parent unwilling to attend eight therapy sessions and perform home exercise protocol

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Therapy Group
Therapy only
Procedure: Regularly ongoing therapy
Active Comparator: Surgery Group
surgical intervention
Procedure: Upper Extremity Tendon transfer
Active Comparator: Botox Injections
botulinum toxin
Procedure: Botulinum Toxin injections in Upper Extremity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Shriners Hospitals Upper Extremity Evaluation (SHUEE)
Time Frame: Initial, 6 mon, 1 year
Initial, 6 mon, 1 year
Box & Blocks
Time Frame: Initial, 6 mon, 1 year
Initial, 6 mon, 1 year
Assisting Hand Assessment (AHA)
Time Frame: Initial, 6 mon, 1 year
Initial, 6 mon, 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Scores on questionnaires that assess participation and patient satisfaction at initial, 6 month and 1 year post intervention.
Time Frame: Initial, 6 mon, 1 year
Initial, 6 mon, 1 year

Collaborators and Investigators

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

Sponsor

Shriners Hospitals for Children

Investigators

  • Principal Investigator: Michelle James, MD, Shriners Hospitals for Children, Northern Calfiornia
  • Principal Investigator: Ann Van Heest, MD, Shriners Hospitals for Children, Twin Cities
  • Principal Investigator: Anita Bagley, PhD, Shriners Hospitals for Children, Northern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2005

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

November 3, 2005

First Submitted That Met QC Criteria

November 3, 2005

First Posted (Estimate)

November 7, 2005

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83004-278826

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.

Clinical Trials on Cerebral Palsy

Clinical Trials on Regularly ongoing therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe