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

Cerebral Palsy Clinical Trial

— UECP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00250081
• Other study ID #: 83004-278826
• Status: Terminated
• Phase: N/A
• First received: November 3, 2005
• Last updated: November 18, 2014
• Start date: February 2005
• Est. completion date: May 2013

Study information

• Verified date: November 2014
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Procedure:
• Upper Extremity Tendon transfer

• Botulinum Toxin injections in Upper Extremity

• Regularly ongoing therapy

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children Chicago	Chicago	Illinois
United States	Shriners Hospitals for Children	Greenville	South Carolina
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Shriners Hospitals for Children, Twin Cities	Minneapolis	Minnesota
United States	Shriners Hospitals for Children Northern California	Sacramento	California
United States	Shriners Hosptials for Children, Intermountain	Salt Lake City	Utah
United States	Shriners Hospitals for Children	Shreveport	Louisiana
United States	Shriners Hosptials for Children	Tampa	Florida
United States	Children's National Medical Center	Washington	District of Columbia
United States	Alfred I duPont Childrens Hospital	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

References & Publications (34)

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Wallen MA, O'flaherty SJ, Waugh MC. Functional outcomes of intramuscular botulinum toxin type A in the upper limbs of children with cerebral palsy: a phase II trial. Arch Phys Med Rehabil. 2004 Feb;85(2):192-200. Erratum in: Arch Phys Med Rehabil. 2994 May;85(5):862. — View Citation

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shriners Hospitals Upper Extremity Evaluation (SHUEE)		Initial, 6 mon, 1 year	No
Primary	Box & Blocks		Initial, 6 mon, 1 year	No
Primary	Assisting Hand Assessment (AHA)		Initial, 6 mon, 1 year	No
Secondary	Scores on questionnaires that assess participation and patient satisfaction at initial, 6 month and 1 year post intervention.		Initial, 6 mon, 1 year	No

External Links

•   Official website for Shriners Hospitals for Children, a network of 22 hospitals that provide expert, no-cost orthopaedic and burn care to children under 18