Does Reducing Spasticity Permit an Increase in Strength?

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00255073
• Date of registration: 15/11/2005
• Primary sponsor: Stanford University
• 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
• 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