Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-03-10 @ 11:32 PM
Study NCT ID:
NCT00004751
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Randomized Study of Selective Dorsal Rhizotomy and Physiotherapy Vs Physiotherapy Alone for Spastic Diplegia
Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
1997-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
OBJECTIVES:
I. Assess the efficacy and safety of selective dorsal rhizotomy and physiotherapy compared with physiotherapy alone in improving gross motor function and reducing spasticity in children with spastic diplegia.
I. Assess the efficacy and safety of selective dorsal rhizotomy and physiotherapy compared with physiotherapy alone in improving gross motor function and reducing spasticity in children with spastic diplegia.
Detailed Description:
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by age and the ability to ambulate 50 feet unaided. Each stratum is block randomized.
Patients are randomly assigned to surgery plus intensive physical therapy versus intensive physical therapy alone.
The surgical procedure is a selective dorsal rhizotomy. Physical therapy (PT) includes passive and active range of motion, facilitation of isolated muscle control, transitional movements, strengthening, transfer skills, and gait training. The PT schedule is 2-hour sessions 5 days a week for 1 month, 1-hour sessions 5 days a week for 5 months, then a standard therapy program for the remainder of the study (total of 6 months). Parents supervise exercise on non-PT days.
Patients are followed at 6, 12, and 24 months.
Patients are randomly assigned to surgery plus intensive physical therapy versus intensive physical therapy alone.
The surgical procedure is a selective dorsal rhizotomy. Physical therapy (PT) includes passive and active range of motion, facilitation of isolated muscle control, transitional movements, strengthening, transfer skills, and gait training. The PT schedule is 2-hour sessions 5 days a week for 1 month, 1-hour sessions 5 days a week for 5 months, then a standard therapy program for the remainder of the study (total of 6 months). Parents supervise exercise on non-PT days.
Patients are followed at 6, 12, and 24 months.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CHS-01699211 | None | None | View |