Vanderbilt University Spasticity Management Program Evaluation Plan

Spasticity Clinical Trial

Official title:

Vanderbilt University Spasticity Management Program Evaluation Plan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179114
• Other study ID #: SMPEP-9.1
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: August 17, 2007
• Start date: August 2002
• Est. completion date: February 2006

Study information

• Verified date: August 2007
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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

Intervention

Drug:
• Botulinum Toxin Type A

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University	Allergan, Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total time (in seconds) spent by caregivers to complete a defined care area task at one year followup.
Primary	Categorical rating by blinded, independent reviewer of baseline and one-year care area task videos.
Secondary	Range of motion score for each care area goal, assigned by physical therapist and compared at baseline vs. one-year followup.
Secondary	Differences in the number of hospital admissions 12 months pre- and 12 months post-program.
Secondary	Differences in costs associated with caregiving 12 months pre- and 12 months post-treatment.
Secondary	Difference in Physician's global assessment of spasticity at baseline and one-year followup.