Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057018
Status:
COMPLETED
Last Update Posted:
2016-09-26
First Post:
2003-03-26
Brief Title:
Improving Arm Mobility and Use After Stroke
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:
The Extremity Constraint Induced Therapy Evaluation EXCITE Trial
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:
An individual suffering a stroke or other brain injury may lose function on one side of the body partial paralysis As the individual shifts activities to favor the unaffected side the problem worsens Constraint induced CI therapy forces the individual to use the neglected arm by restraining the good arm in a sling This study examines the effectiveness of CI therapy for improving arm motion after stroke
Detailed Description:
Profoundly impaired motor dysfunction is a major consequence of stroke As a result a large number of the more than 700000 people in America sustaining a stroke each year have limitations in motor ability and compromised quality of life Therapeutic interventions designed to enhance motor function and promote independent use of an impaired upper extremity are quite limited
CI movement therapy or forced use involves motor restriction of the less effected upper extremity for 2 weeks Over this time repetitive use of the more effected upper extremity is promoted for many hours a day This treatment produces long lasting improvements in extremity use among patients who are more than 1 year post-stroke and who have an ability to initiate some extension in wrist and digit joints
This study will determine if CI therapy for a hemiparetic upper extremity in patients with sub-acute 3 to 9 months post-cerebral infarct stroke will lead to functional improvements and enhanced quality of life measures more than usual care
Patients are randomized into a treatment or usual care group and stratified by movement capability into higher and lower functioning categories Higher functioning patients are defined as those who have at least 20 degrees of active wrist extension and 10 degrees of active finger extension at each digit joint Lower functioning patients are defined as those with at least 10 degrees of wrist extension and 10 degrees of extension at each thumb joint and all joints of two other digits Patients randomized into the control group receive treatment one year later to permit replication efforts for findings using this therapy in patients with chronic stroke
The intervention consists of making patients use their impaired arms by constraining movement in the less impaired limb for most waking hours over a 2 week period The constraint is a taped splint in which the hand rests to prevent limb use but enable protective responses A micro-switch within the splint will permit monitoring of contact time wearing Each weekday for 2 weeks patients come to the cliniclaboratory for specific task training Evaluations in laboratory and actual use tests are made prior to treatment 2 weeks later and at 4 month intervals thereafter Changes in psychosocial functioning will also be measured Primary outcomes include the Wolf Motor Function Test and the Motor Activity Log Secondary outcomes include Stroke Impact Scale Actual Amount of Use Test and accelerometry
CI movement therapy or forced use involves motor restriction of the less effected upper extremity for 2 weeks Over this time repetitive use of the more effected upper extremity is promoted for many hours a day This treatment produces long lasting improvements in extremity use among patients who are more than 1 year post-stroke and who have an ability to initiate some extension in wrist and digit joints
This study will determine if CI therapy for a hemiparetic upper extremity in patients with sub-acute 3 to 9 months post-cerebral infarct stroke will lead to functional improvements and enhanced quality of life measures more than usual care
Patients are randomized into a treatment or usual care group and stratified by movement capability into higher and lower functioning categories Higher functioning patients are defined as those who have at least 20 degrees of active wrist extension and 10 degrees of active finger extension at each digit joint Lower functioning patients are defined as those with at least 10 degrees of wrist extension and 10 degrees of extension at each thumb joint and all joints of two other digits Patients randomized into the control group receive treatment one year later to permit replication efforts for findings using this therapy in patients with chronic stroke
The intervention consists of making patients use their impaired arms by constraining movement in the less impaired limb for most waking hours over a 2 week period The constraint is a taped splint in which the hand rests to prevent limb use but enable protective responses A micro-switch within the splint will permit monitoring of contact time wearing Each weekday for 2 weeks patients come to the cliniclaboratory for specific task training Evaluations in laboratory and actual use tests are made prior to treatment 2 weeks later and at 4 month intervals thereafter Changes in psychosocial functioning will also be measured Primary outcomes include the Wolf Motor Function Test and the Motor Activity Log Secondary outcomes include Stroke Impact Scale Actual Amount of Use Test and accelerometry
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