Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179114
Status:
COMPLETED
Last Update Posted:
2007-08-20
First Post:
2005-09-13
Brief Title:
Vanderbilt University Spasticity Management Program Evaluation Plan
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Vanderbilt University Spasticity Management Program Evaluation Plan
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 participants 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 individuals care area tasks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None