Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059696
Status:
COMPLETED
Last Update Posted:
2016-09-26
First Post:
2003-05-01
Brief Title:
Treatment for Movement Problems in Elderly Stroke Patients
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
A Treatment for Excess Motor Disability in the Aged
Status:
COMPLETED
Status Verified Date:
2011-05
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:
After a stroke many patients are left with an impaired arm Restricting the use of the good arm may improve the use of the bad arm In Constraint-Induced Movement therapy CI therapy the good arm is put in a sling to force increased use of the bad arm The bad arm is also trained each day for several weeks This study will evaluate the effectiveness of CI therapy in patients with chronic disability after stroke and whether the rate of recovery is decreased in elderly patients
Detailed Description:
Stroke afflicts over 700000 Americans each year Behavioral techniques that impact plasticity of the nervous system need to be incorporated into practical evidence-based therapeutic interventions This is especially true at a time when the duration of treatments reimbursed by third party payers has shortened
CI therapy was derived from basic research with animal subjects and human volunteers Randomized controlled studies indicate that it can substantially reduce the motor deficit of patients with mild to moderate chronic strokes and can increase their independence over a period of years CI therapy involves motor restriction of the less affected upper extremity for a period of 2 to 3 weeks while concurrently training the more affected upper limb This gives rise to massed or concentrated repetitive use of the more affected extremity CI therapy leads to a large increase in use-dependent cortical reorganization involving the recruitment of other regions of the brain in the innervation of the more affected extremity movement
One of the main aims of the proposed research is to determine if CI therapy can be used with therapeutic success for increasing the amount of real-world extremity use in patients with chronic stroke Another aim is to ascertain whether the locus of the lesion and its size as determined by MRI are factors influencing the extent to which motor function can be recovered through the use of CI therapy
Eighty patients with chronic stroke will be randomly assigned to receive either CI therapy or a General Fitness control intervention Two years after study entry the patients in the control group will be crossed over to receive CI therapy Primary outcome measures will be a laboratory motor function test and amount of extremity use in the real-world setting Changes in psychosocial functioning will also be measured
CI therapy was derived from basic research with animal subjects and human volunteers Randomized controlled studies indicate that it can substantially reduce the motor deficit of patients with mild to moderate chronic strokes and can increase their independence over a period of years CI therapy involves motor restriction of the less affected upper extremity for a period of 2 to 3 weeks while concurrently training the more affected upper limb This gives rise to massed or concentrated repetitive use of the more affected extremity CI therapy leads to a large increase in use-dependent cortical reorganization involving the recruitment of other regions of the brain in the innervation of the more affected extremity movement
One of the main aims of the proposed research is to determine if CI therapy can be used with therapeutic success for increasing the amount of real-world extremity use in patients with chronic stroke Another aim is to ascertain whether the locus of the lesion and its size as determined by MRI are factors influencing the extent to which motor function can be recovered through the use of CI therapy
Eighty patients with chronic stroke will be randomly assigned to receive either CI therapy or a General Fitness control intervention Two years after study entry the patients in the control group will be crossed over to receive CI therapy Primary outcome measures will be a laboratory motor function test and amount of extremity use in the real-world setting Changes in psychosocial functioning will also be measured
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