Vanderbilt University Spasticity Management Program Evaluation Plan

NCT00179114 | Completed Phase 4

• 1 other identifier: SMPEP-9.1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spasticity

Keywords

Spasticity; Developmental Disabilities; Intrathecal baclofen (ITB); Botulinum Toxin Type A (Botox)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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.

Interventions

Botulinum Toxin Type A DRUG

Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• Allergan: collaborator
• Medtronic: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Muscle Spasticity; Developmental Disabilities

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• David Charles, MD

  Vanderbilt University Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: August 1, 2002
• Study Completion: February 1, 2006
• Last Updated: August 20, 2007

Record last verified: 2007-08

Locations

US (1)