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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 2 June 2014
Main ID:  NCT00255073
Date of registration: 15/11/2005
Primary sponsor: University of Southern California
Public title: Does Reducing Spasticity Permit an Increase in Strength?
Scientific title: Does Reducing Spasticity Permit an Increase in Strength?
Date of first enrolment: January 2005
Target sample size: 10
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00255073
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
United States
Contacts
Name:   Terence Sanger, md,phd
Address: 
Telephone:
Email:
Affiliation:  Stanford University
Key inclusion & exclusion criteria

Inclusion Criteria:

- 1. Diagnosis of Cerebral Palsy 2. Spasticity at extensor muscle groups of one or both
ankles according to the definition of the Task Force on Childhood Motor Disorders,
and as evidenced by the presence of a spastic catch or velocity-dependent hypertonia
on rapid passive muscle lengthening while the subject attempts to maintain a relaxed
state 3. Ambulatory without assistive devices 4. Sufficient ability to follow
instructions to be able to comply with the strengthening program and strength testing

Exclusion Criteria:

- 1. Contracture at the ankle, or a limitation of the passive range of motion such that
neutral position is not achievable with the knee extended.

2. Hypersensitivity or allergy to Baclofen or related medications, or any medical
condition that would be expected to increase the risks of this study 3. Respiratory
difficulty due to weakness, restrictive lung disease, obstructive lung disease,
tracheomalacia, or laryngeal weakness 4. Renal failure or chronic kidney disease 5.
Pregnancy or planned pregnancy (sexually active girls will be asked to take a urine
pregnancy test prior to study entry) 6. Difficulty maintaining head position while
standing or seated 7. Current use of other anti-spasticity agents, including valium,
tizanidine, clonidine, dantrolene, or similar agents 8. Use of oral baclofen within 3
months prior to study entry 9. Injection of botulinum toxin into the calf muscles
within 3 months prior to study entry 10. Prior implantation of a baclofen pump or
deep-brain stimulator 11. Seizure within previous two years 12. Lower extremity
dystonia 13. Bradykinesia or evidence of parkinsonism 14. Spinal cord injury 15.
Neurodegenerative disease 16. Ankle, foot, lower leg, or Achilles tendon surgery
within the previous year 17. Dorsal rhizotomy or neurotomy



Age minimum: 5 Years
Age maximum: 18 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Spastic Diplegic Cerebral Palsy
Intervention(s)
Drug: baclofen
Primary Outcome(s)
Maximal Voluntary Contraction
Secondary Outcome(s)
H reflex
Secondary ID(s)
BACLOFEN
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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