Internet Stroke Center Home Stroke Trials Registry
 
National Institute of Neurological Disorders & Stroke
American Stroke Association
Washington University School of Medicine
 
 Trials Directories
Ongoing Trials
Completed Trials
Acute Stroke Trials
Hemorrhage Trials
Prevention Trials
Recovery Trials
 Interventions
Drugs - By Name
Drugs - By Category
Procedures
Recovery Therapies
 Assessment Scales
Specific Stroke Scales
Stroke Scales Overview
 Stroke Trial Links
Government Sites
Independent Sites
 News & Updates
Update List
General Stroke News
About this Site
Submit Your Trial
Send Feedback

 Search for Trials

PubMed
We comply with the "Health on the Net" (HON) code of standards for trustworthy health information: verify here.



 
Stroke Interventions in Clinical Trials
Printable Version
EXCITE
Extremity Constraint-Induced Therapy



Principal Investigator
Steven L. Wolf, Ph, DPT, FAPTA

PI Address
Department of Rehabilitation Medicine
Emory University School of Medicine
1441 Clifton Road NE
Atlanta, Georgia 30322

Contact Email
swolf@emory.edu

Sponsor



Study Size Actual:229
Study Size Planned:240
Centers Actual:7
Centers Planned:7
Max Time from onset:12 Months
Follow-up Duration:2 Years
ISRCTN#NCT00057018
Status:
Recruitment is complete with 94% (229) enrolled, 14 publications, and outcome papers in press. Results will be available later this year when they are published.

Purpose:
To determine whether constraint-induced movement therapy (CIMT) is as effective in subacute stroke patients (3 - 9 months poststroke) as it is in chronic stroke patients ( > 12 months post-stroke)

Interventions:
Constraint-induced therapy
Rehabilation approach: increased use of the affected extremity after stroke may promote recovery.

Location(s):
Georgia, Alabama, California, Ohio, North Carolina, Florida

Year Started: 2001
Year Published: 2006


Design:
Multi-center, randomized, blinded crossover study.

Inclusion Criteria
Patients presenting within 3 - 9 months of stroke (< 12 months) causing upper extremity impairment, and who have at least some ability to extend the disabled wrist and digits, will be eligible for this trial.

Patient Involvement:
Eligible patients will be randomized into subacute and chronic treatment groups. Upon randomization, the subacute group will receive CIMT, which involves constraining the functional arm during waking hours for two weeks, and training the disabled arm to perform basic activities for 6 hours every weekday during that period. The chronic treatment group will receive CIMT at 1 year post-randomization. Patients will be provided with standard medical and rehabilitative care throughout.

Primary Outcome:
The Wolf Motor Function Test (WMFT), a measure of laboratory time and strength-based ability and quality of movement (functional ability), and the Motor Activity Log (MAL), a measure of how well and how often 30 common daily activities are performed.

Secondary Outcome:
Changes in psychosocial functioning.

Results:
The CIMT group achieved significant improvements in hand/arm movement that lasted up to a year following treatment, with the CIMT group having a faster performance time of 19.3 seconds to 9.3 seconds [52% reduction] over the control group's time of 24.0 seconds to 17.7 seconds [26% reduction] on the WMFT. Also the CIMT group achieved an increase from 1.21 to 2.13 vs from 1.15 to 1.65 in the control group in the MAL Amount of Use, and increase from 1.26 to 2.23 vs 1.18 to 1.66 on the MAL Quality of Movement scale.
2 year follow-up results:
The effects at 24 months after treatment did not decline from those at 12 months for time taken to complete the WMFT (-0.32 s, 95% CI -3.70 to 3.06), for weight lifted in the WMFT (-1.39 kg, -2.74 to -0.04), for WMFT grip strength (-4.39 kg, -6.91 to -1.86), for amount of use in the MAL (-0.17, -0.38 to 0.04), or for how well the limb was used in the MAL (-0.14, -0.34 to 0.06). The additional changes were in the direction of increased therapeutic effect. For the strength components of the WMFT, p<0.0001. INTERPRETATION: Patients who have mild to moderate impairments 3-9 months poststroke have substantial improvement in functional use of the paretic upper limb and quality of life 2 years after a 2-week CIMT intervention. Thus, this intervention has persistent benefits.

Source of Information:
EXCITE web site.

Web Links and Publications:
EXCITe Trial Web Site

Retention of upper limb function in stroke survivors who have received constraint-induced movement therapy: the EXCITE randomised trial.
Lancet Neurol 2008 Jan;7(1):33-40

The EXCITE trial: a major step forward for restorative therapies in stroke.
Stroke 2007 Jul;38(7):2204-5

Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial.
JAMA 2006 Nov 1;296(17):2095-104

The EXCITE trial: attributes of the Wolf Motor Function Test in patients with subacute stroke.
Neurorehabil Neural Repair 2005 Sep;19(3):194-205

Methods for a multisite randomized trial to investigate the effect of constraint-induced movement therapy in improving upper extremity function among adults recovering from a cerebrovascular stroke.
Neurorehabil Neural Repair 2003 Sep;17(3):137-52

ClinicalTrials.gov
http://clinicaltrials.gov/ct2/show/NCT00057018?term=NCT00057018&rank=1

This information last updated on: 1/28/2009

Reviewed on: 01/28/2009.

UID: 186

   

Internet Stroke Center at Washington University:
HOME | ABOUT | PRIVACY POLICY | CONTACT

Copyright © 1997-2009 - Internet Stroke Center. All rights reserved.                                           Last modified: Friday, November 20, 2009