Cerebral Palsy (CP), Spastic/Dystonic Quadriplegia
Conditions
Keywords
CP, Cerebral Palsy, Tone Management, Dystonic, Spastic, Spasticity, Intrathecal Baclofen Pump, Combined Dorsal/Ventral Rhizotomy
Brief summary
Patients with spastic/dystonic quadriplegia (GMFCS IV/V) are often severely disabled by their tone, and require surgical tone management to improve quality of life, allow for better function, improve comfort, and range of motion. This has historically been limited to Intrathecal Baclofen (ITB) pumps, which are effective for up to 85% of patients but carry significant morbidity / complications and are not appropriate for many patients. More recently, combined dorsal/ventral rhizotomy (CR) has emerged as an alternative means for tone control, a one-time surgery with no required hardware implantation. However, more information is needed regarding long-term outcomes of this procedure in addition to comparative outcomes of ITB. This information will lead to improved patient selection, counseling, and care. This is a prospectively enrolled, single-center study, involving survey administration and clinical observation of outcomes pre- and post-surgery.
Interventions
None listed
Sponsors
Boston Children's Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Any patients undergoing intrathecal baclofen pump insertion or combined dorsal ventral rhizotomy at Boston Children's Hospital. * Must be at least 6 years of age at time of enrollment
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improved Spasticity Score | From enrollment to 5 years | We will study changes in Spasticity using the Modified Ashworth Scale in participants over the course of this study. |
| Improved Dystonia Score | From enrollment to 5 years. | We will use the Barry Albright Dystonia Scale to measure changes in dystonia in participants over the course of this study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Quality of Life Improvements | From enrollment to 5 years | We will use the CP-Child survey to measure quality of life changes in participants over the course of this study. Specifically looking at trends in caregiver satisfaction with hygiene, and comfort. |
| Reduced Surgical Complications | From enrollment to 5 years. | We will review outcomes for our participants to quantify surgical complications such as infection, malfunction, re-operation, spinal fluid leak, prolonged urinary retention, muscle wasting, and decubitus ulcer formation. |
Countries
United States
Contacts
CONTACTAdam Porter, Research Manager, MPH
PRINCIPAL_INVESTIGATORWeston Northam, MD
Boston Children's Hospital
Outcome results
None listed