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Sponsors and Collaborators: |
Vanderbilt University Allergan Medtronic |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00179114 |
People with severe developmental disabilities frequently have comorbidities that make providing care to them more difficult. Spasticity is one such comorbidity. It produces increased muscle tone that can cause stiffness in joints and bodily contortions that can interfere with all of the major types of care provided to participants. Typically, care areas include splinting, hygiene, dressing, transfers, positioning, ambulation, and engaging in other functional activities. Moreover, persons with spasticity often experience pain.
Typically, spasticity is managed by health care providers using a combination of the following therapies:
Condition | Intervention | Phase |
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Spasticity |
Drug: Botulinum Toxin Type A Drug: Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Vanderbilt University Spasticity Management Program Evaluation Plan |
Estimated Enrollment: | 20 |
Study Start Date: | August 2002 |
Estimated Study Completion Date: | February 2006 |
As individuals are identified as appropriate participants for the Program and consent is obtained, the care team for each person, consisting of both medical and caregiver staff, will define up to three specific care area goals and related tasks for treatment. A comprehensive spasticity management program will then be developed for the individual. Clinical and outcome assessments at baseline and at follow-up will include measures of range of motion, global spasticity according to a modified Ashworth scale, and the time and number of staff required for the task. In addition, video will be obtained of caregivers performing each participant's care area tasks at baseline and follow-up to allow an independent external reviewer to judge task difficulty. Treatment will be provided as outlined by the spasticity management plan. Follow-up evaluations will be conducted when the participant is at least one year from their initial Botulinum injection, or are one year post-implant for ITB participants. When the participant is exited from the study, Survey Physician will be asked to rate the overall impact of the Program on each of the individual's care area tasks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37212 |
Principal Investigator: | David Charles, MD | Vanderbilt University Department of Neurology |
Study ID Numbers: | SMPEP-9.1 |
Study First Received: | September 13, 2005 |
Last Updated: | August 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00179114 |
Health Authority: | United States: Food and Drug Administration |
Spasticity Developmental Disabilities Intrathecal baclofen (ITB) Botulinum Toxin Type A (Botox) |
Developmental Disabilities Signs and Symptoms Muscle Spasticity Botulinum Toxins Muscular Diseases |
Musculoskeletal Diseases Muscle Hypertonia Baclofen Neurologic Manifestations Botulinum Toxin Type A |
Neuromuscular Manifestations Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Neuromuscular Agents |
Pharmacologic Actions Muscle Relaxants, Central Therapeutic Uses GABA Agonists GABA Agents Peripheral Nervous System Agents Central Nervous System Agents |