Cerebral PalsyUECPNCT00250081

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

A study testing Upper Extremity Tendon transfer, Botulinum Toxin injections in Upper Extremity and Regularly ongoing therapy in people with Cerebral Palsy, run by Shriners Hospitals for Children at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 4 to 17 years
Conditions the study is for: Cerebral Palsy
What is being tested?: Upper Extremity Tendon transfer, Botulinum Toxin injections in Upper Extremity and Regularly ongoing therapy
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 10 sitesUnited States
Study dates: Feb 2005to May 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

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

Other trials in United States

About this study

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

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.

Read the detailed description

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

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.
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.

Conditions: Cerebral Palsy
Being tested: Upper Extremity Tendon transfer, Botulinum Toxin injections in Upper Extremity, Regularly ongoing therapy
Keywords: Cerebral Palsy, Tendon Transfer, Botulinum Toxin Type A, Occupational Therapy, Child
Medical subject headings: Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Upper Extremity Tendon transferProcedure or surgery
Botulinum Toxin injections in Upper ExtremityProcedure or surgery
Regularly ongoing therapyProcedure or surgery

Study groups in NCT00250081
Study group	Role	What they receive
Therapy Group	Active comparator	Therapy only Receives: Procedure: Regularly ongoing therapy
Surgery Group	Active comparator	surgical intervention Receives: Procedure: Upper Extremity Tendon transfer
Botox Injections	Active comparator	botulinum toxin Receives: Procedure: Botulinum Toxin injections in Upper Extremity

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2005May 2013

First posted7 Nov 2005 (estimated)
Study startFeb 2005
Primary completionMay 2013
Study completionMay 2013

Why it stopped: Accrual is complete.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (34)Papers the sponsor has linked to this study.
Other trials for Cerebral PalsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00250081
Sponsor's protocol ID: 83004-278826
Acronym: UECP
Status last verified: Nov 2014
First submitted: 3 Nov 2005
Last updated: 19 Nov 2014
Results posted: No
Data monitoring committee: Yes

Publications

BAX MC. TERMINOLOGY AND CLASSIFICATION OF CEREBRAL PALSY. Dev Med Child Neurol. 1964 Jun;6:295-7. doi: 10.1111/j.1469-8749.1964.tb10791.x. No abstract available.
PubMed 14155190
Autti-Ramo I, Larsen A, Taimo A, von Wendt L. Management of the upper limb with botulinum toxin type A in children with spastic type cerebral palsy and acquired brain injury: clinical implications. Eur J Neurol. 2001 Nov;8 Suppl 5:136-44. doi: 10.1046/j.1468-1331.2001.00046.x.
PubMed 11851742
Autti-Ramo I, Larsen A, Peltonen J, Taimo A, von Wendt L. Botulinum toxin injection as an adjunct when planning hand surgery in children with spastic hemiplegia. Neuropediatrics. 2000 Feb;31(1):4-8. doi: 10.1055/s-2000-15289.
PubMed 10774988
Wall SA, Chait LA, Temlett JA, Perkins B, Hillen G, Becker P. Botulinum A chemodenervation: a new modality in cerebral palsied hands. Br J Plast Surg. 1993 Dec;46(8):703-6. doi: 10.1016/0007-1226(93)90203-n.
PubMed 8298785
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. doi: 10.1016/j.apmr.2003.05.008.
PubMed 14966702
Fehlings D, Rang M, Glazier J, Steele C. An evaluation of botulinum-A toxin injections to improve upper extremity function in children with hemiplegic cerebral palsy. J Pediatr. 2000 Sep;137(3):331-7. doi: 10.1067/mpd.2000.108393.
PubMed 10969256
El-Said NS. Selective release of the flexor origin with transfer of flexor carpi ulnaris in cerebral palsy. J Bone Joint Surg Br. 2001 Mar;83(2):259-62. doi: 10.1302/0301-620x.83b2.10763.
PubMed 11284577
Hoffer MM, Lehman M, Mitani M. Long-term follow-up on tendon transfers to the extensors of the wrist and fingers in patients with cerebral palsy. J Hand Surg Am. 1986 Nov;11(6):836-40. doi: 10.1016/s0363-5023(86)80232-5.
PubMed 3794239
Thometz JG, Tachdjian M. Long-term follow-up of the flexor carpi ulnaris transfer in spastic hemiplegic children. J Pediatr Orthop. 1988 Jul-Aug;8(4):407-12. doi: 10.1097/01241398-198807000-00005.
PubMed 3392191
Tonkin M, Gschwind C. Surgery for cerebral palsy: Part 2. Flexion deformity of the wrist and fingers. J Hand Surg Br. 1992 Aug;17(4):396-400. doi: 10.1016/s0266-7681(05)80261-x.
PubMed 1402265
Wenner SM, Johnson KA. Transfer of the flexor carpi ulnaris to the radial wrist extensors in cerebral palsy. J Hand Surg Am. 1988 Mar;13(2):231-3. doi: 10.1016/s0363-5023(88)80055-8.
PubMed 3351249
Wolf TM, Clinkscales CM, Hamlin C. Flexor carpi ulnaris tendon transfers in cerebral palsy. J Hand Surg Br. 1998 Jun;23(3):340-3. doi: 10.1016/s0266-7681(98)80054-5.
PubMed 9665522
Beach WR, Strecker WB, Coe J, Manske PR, Schoenecker PL, Dailey L. Use of the Green transfer in treatment of patients with spastic cerebral palsy: 17-year experience. J Pediatr Orthop. 1991 Nov-Dec;11(6):731-6. doi: 10.1097/01241398-199111000-00006.
PubMed 1960196
Strecker WB, Emanuel JP, Dailey L, Manske PR. Comparison of pronator tenotomy and pronator rerouting in children with spastic cerebral palsy. J Hand Surg Am. 1988 Jul;13(4):540-3. doi: 10.1016/s0363-5023(88)80091-1.
PubMed 3418056
Manske PR. Redirection of extensor pollicis longus in the treatment of spastic thumb-in-palm deformity. J Hand Surg Am. 1985 Jul;10(4):553-60. doi: 10.1016/s0363-5023(85)80082-4.
PubMed 4020069

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Cerebral Palsy trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00250081
Acronym / sponsor ID: UECP / 83004-278826
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy, Tendon Transfer, Botulinum Toxin Type A, Occupational Therapy, Child
Study type: Interventional
Recruitment status: TerminatedReason stopped: Accrual is complete.
Enrolment: 38 participants (actual)
Lead sponsor: Shriners Hospitals for ChildrenUniversity, hospital or other
Study start: Feb 2005
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 7 Nov 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

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.
To determine if serial Botulinum toxin injections have long-term beneficial effects on upper extremity function which outlast their paralytic effects.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Therapy Group	Active comparator	Procedure: Regularly ongoing therapyTherapy only
Surgery Group	Active comparator	Procedure: Upper Extremity Tendon transfersurgical intervention
Botox Injections	Active comparator	Procedure: Botulinum Toxin injections in Upper Extremitybotulinum toxin

Who may qualify

Ages: 4 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Upper Extremity Tendon transfer	Procedure or surgery	Surgery Group
Botulinum Toxin injections in Upper Extremity	Procedure or surgery	Botox Injections
Regularly ongoing therapy	Procedure or surgery	Therapy Group

Primary outcome

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

1 secondary outcome

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

Results and safety

The study was stopped early (reason given: Accrual is complete.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
Background: PubMed 14155190BAX MC. TERMINOLOGY AND CLASSIFICATION OF CEREBRAL PALSY. Dev Med Child Neurol. 1964 Jun;6:295-7. doi: 10.1111/j.1469-8749.1964.tb10791.x. No abstract available.
Background: PubMed 11851742Autti-Ramo I, Larsen A, Taimo A, von Wendt L. Management of the upper limb with botulinum toxin type A in children with spastic type cerebral palsy and acquired brain injury: clinical implications. Eur J Neurol. 2001 Nov;8 Suppl 5:136-44. doi: 10.1046/j.1468-1331.2001.00046.x.
Background: PubMed 10774988Autti-Ramo I, Larsen A, Peltonen J, Taimo A, von Wendt L. Botulinum toxin injection as an adjunct when planning hand surgery in children with spastic hemiplegia. Neuropediatrics. 2000 Feb;31(1):4-8. doi: 10.1055/s-2000-15289.
Background: PubMed 8298785Wall SA, Chait LA, Temlett JA, Perkins B, Hillen G, Becker P. Botulinum A chemodenervation: a new modality in cerebral palsied hands. Br J Plast Surg. 1993 Dec;46(8):703-6. doi: 10.1016/0007-1226(93)90203-n.
Background: PubMed 14966702Wallen 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. doi: 10.1016/j.apmr.2003.05.008.
Background: PubMed 10969256Fehlings D, Rang M, Glazier J, Steele C. An evaluation of botulinum-A toxin injections to improve upper extremity function in children with hemiplegic cerebral palsy. J Pediatr. 2000 Sep;137(3):331-7. doi: 10.1067/mpd.2000.108393.
Background: PubMed 11284577El-Said NS. Selective release of the flexor origin with transfer of flexor carpi ulnaris in cerebral palsy. J Bone Joint Surg Br. 2001 Mar;83(2):259-62. doi: 10.1302/0301-620x.83b2.10763.
Background: PubMed 3794239Hoffer MM, Lehman M, Mitani M. Long-term follow-up on tendon transfers to the extensors of the wrist and fingers in patients with cerebral palsy. J Hand Surg Am. 1986 Nov;11(6):836-40. doi: 10.1016/s0363-5023(86)80232-5.
Background: PubMed 3392191Thometz JG, Tachdjian M. Long-term follow-up of the flexor carpi ulnaris transfer in spastic hemiplegic children. J Pediatr Orthop. 1988 Jul-Aug;8(4):407-12. doi: 10.1097/01241398-198807000-00005.
Background: PubMed 1402265Tonkin M, Gschwind C. Surgery for cerebral palsy: Part 2. Flexion deformity of the wrist and fingers. J Hand Surg Br. 1992 Aug;17(4):396-400. doi: 10.1016/s0266-7681(05)80261-x.
Background: PubMed 3351249Wenner SM, Johnson KA. Transfer of the flexor carpi ulnaris to the radial wrist extensors in cerebral palsy. J Hand Surg Am. 1988 Mar;13(2):231-3. doi: 10.1016/s0363-5023(88)80055-8.
Background: PubMed 9665522Wolf TM, Clinkscales CM, Hamlin C. Flexor carpi ulnaris tendon transfers in cerebral palsy. J Hand Surg Br. 1998 Jun;23(3):340-3. doi: 10.1016/s0266-7681(98)80054-5.
Official website for Shriners Hospitals for Children, a network of 22 hospitals that provide expert, no-cost orthopaedic and burn care to children under 18Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michelle James, MD principal investigator

Shriners Hospitals for Children, Northern Calfiornia

Ann Van Heest, MD principal investigator

Shriners Hospitals for Children, Twin Cities

Anita Bagley, PhD principal investigator

Shriners Hospitals for Children, Northern California

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Accrual is complete.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shriners Hospitals Upper Extremity Evaluation (SHUEE) (time frame: Initial, 6 mon, 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00250081, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.