Vanderbilt University Spasticity Management Program Evaluation Plan
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Purpose
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:
- Physical / occupational therapy (PT / OT)
- Oral medication
- Botox injections
- Intrathecal baclofen administered by the Medtronic SyncroMed pump (ITB)
- Orthopedic / neurological surgery
| Condition | Intervention | Phase |
|---|---|---|
|
Spasticity |
Drug: Botulinum Toxin Type A Drug: Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Vanderbilt University Spasticity Management Program Evaluation Plan |
- Total time (in seconds) spent by caregivers to complete a defined care area task at one year followup.
- Categorical rating by blinded, independent reviewer of baseline and one-year care area task videos.
- Range of motion score for each care area goal, assigned by physical therapist and compared at baseline vs. one-year followup.
- Differences in the number of hospital admissions 12 months pre- and 12 months post-program.
- Differences in costs associated with caregiving 12 months pre- and 12 months post-treatment.
- Difference in Physician's global assessment of spasticity at baseline and one-year followup.
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult with spasticity residing at Clover Bottom Developmental Center in Nashville, Tennessee.
- Spasticity must interfere with daily functioning.
- Care team must be able to identify at least one treatment goal for the potential participant.
Exclusion Criteria:
- Family or guardian is unwilling to provide written informed consent.
- Spasticity does not interfere with patient's day-to-day care.
- Staff who provide daily care are unable to identify a clear treatment goal.
Contacts and Locations| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37212 | |
| Principal Investigator: | David Charles, MD | Vanderbilt University Department of Neurology |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00179114 History of Changes |
| Other Study ID Numbers: | SMPEP-9.1 |
| Study First Received: | September 13, 2005 |
| Last Updated: | August 17, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Vanderbilt University:
|
Spasticity Developmental Disabilities Intrathecal baclofen (ITB) Botulinum Toxin Type A (Botox) |
Additional relevant MeSH terms:
|
Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Baclofen Botulinum Toxins Botulinum Toxins, Type A GABA-B Receptor Agonists |
GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Muscle Relaxants, Central Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Dyskinesia Agents |
ClinicalTrials.gov processed this record on May 23, 2013