Vanderbilt University Spasticity Management Program Evaluation Plan

NCT ID: NCT00179114

Last Updated: 2007-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2006-02-28

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

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.

Conditions

Spasticity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Botulinum Toxin Type A

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Medtronic

INDUSTRY

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Principal Investigators

David Charles, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Department of Neurology

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

SMPEP-9.1

Identifier Type: -

Identifier Source: org_study_id