Status:
COMPLETED
Does Reducing Spasticity Permit an Increase in Strength?
Lead Sponsor:
University of Southern California
Conditions:
Spastic Diplegic Cerebral Palsy
Eligibility:
All Genders
5-18 years
Phase:
PHASE2
Brief Summary
Reduction of spasticity has been a major focus of the treatment of childhood cerebral palsy, resulting in numerous treatment strategies that target various parts of the motor system. However, in many ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00255073
Start Date
January 1 2005
End Date
April 1 2006
Last Update
May 23 2014
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305-5235