Vanderbilt University Spasticity Management Program Evaluation Plan

Spasticity Clinical Trial

Official title: Vanderbilt University Spasticity Management Program Evaluation Plan

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity

• NCT number: NCT00179114
• Study type: Interventional
• Source: Vanderbilt University
• Status: Completed
• Phase: Phase 4
• Start date: August 2002
• Completion date: February 2006