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

Not Applicable

Terminated

• Conditions: Cerebral Palsy
• Interventions: Procedure: Upper Extremity Tendon transfer; Procedure: Botulinum Toxin injections in Upper Extremity; Procedure: Regularly ongoing therapy

• Registration Number: NCT00250081
• Lead Sponsor: Shriners Hospitals for Children

Brief 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.

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 Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-11-03
• Study First Submitted QC: 2005-11-03
• Study First Posted: 2005-11-07
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery Group	Upper Extremity Tendon transfer	surgical intervention
Botox Injections	Botulinum Toxin injections in Upper Extremity	botulinum toxin
Therapy Group	Regularly ongoing therapy	Therapy only

Primary Outcome Measures

Name	Time	Method
Shriners Hospitals Upper Extremity Evaluation (SHUEE)	Initial, 6 mon, 1 year
Box & Blocks	Initial, 6 mon, 1 year
Assisting Hand Assessment (AHA)	Initial, 6 mon, 1 year

Secondary Outcome Measures

Name	Time	Method
Scores on questionnaires that assess participation and patient satisfaction at initial, 6 month and 1 year post intervention.	Initial, 6 mon, 1 year

Trial Locations

Locations (9)

Shriners Hosptials for Children, Intermountain; 🇺🇸 Salt Lake City, Utah, United States

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

Alfred I duPont Childrens Hospital; 🇺🇸 Wilmington, Delaware, United States

Shriners Hospitals for Children Chicago; 🇺🇸 Chicago, Illinois, United States

Shriners Hospitals for Children, Twin Cities; 🇺🇸 Minneapolis, Minnesota, United States

Shriners Hospitals for Children; 🇺🇸 Greenville, South Carolina, United States

Shriners Hospitals for Children Northern California; 🇺🇸 Sacramento, California, United States

Shriners Hosptials for Children; 🇺🇸 Tampa, Florida, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States