Vanderbilt University Spasticity Management Program Evaluation Plan

This study has been completed.
Sponsor:
Collaborators:
Allergan
Medtronic
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00179114
First received: September 13, 2005
Last updated: August 17, 2007
Last verified: August 2007
  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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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
Detailed Description:

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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179114

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Allergan
Medtronic
Investigators
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 April 16, 2014