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Improving Arm Mobility and Use After Stroke

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Constraint-induced movement therapy
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring stroke, cerebrovascular accident, upper extremity, physical therapy, constraint-induced therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria 3 to 9 months post cerebral infarct or 1 year post injury 2.5 or lower on the Motor Activity Log scale >= 10 degrees of active wrist extension >= 10 degrees of extension of all joints of thumb and two other digits Ability to perform wrist/finger extension movements three times within one minute

Sites / Locations

  • University of Alabama at Birmingham
  • University of Southern California
  • University of Florida
  • Emory University
  • University of North Carolina at Chapel Hill
  • Wake Forest University School of Medicine
  • Ohio State University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 26, 2003
Last Updated
September 23, 2016
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00057018
Brief Title
Improving Arm Mobility and Use After Stroke
Official Title
The Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
January 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

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 700,000 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 clinic/laboratory 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
stroke, cerebrovascular accident, upper extremity, physical therapy, constraint-induced therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
229 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Constraint-induced movement therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 3 to 9 months post cerebral infarct or 1 year post injury 2.5 or lower on the Motor Activity Log scale >= 10 degrees of active wrist extension >= 10 degrees of extension of all joints of thumb and two other digits Ability to perform wrist/finger extension movements three times within one minute
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven L Wolf, PhD/PT/FAPTA
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
9009-9006
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0154
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7135
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1234
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7243897
Citation
Ostendorf CG, Wolf SL. Effect of forced use of the upper extremity of a hemiplegic patient on changes in function. A single-case design. Phys Ther. 1981 Jul;61(7):1022-8. doi: 10.1093/ptj/61.7.1022.
Results Reference
background
PubMed Identifier
2707361
Citation
Wolf SL, Lecraw DE, Barton LA, Jann BB. Forced use of hemiplegic upper extremities to reverse the effect of learned nonuse among chronic stroke and head-injured patients. Exp Neurol. 1989 May;104(2):125-32. doi: 10.1016/s0014-4886(89)80005-6.
Results Reference
background
PubMed Identifier
8169577
Citation
Taub E, Crago JE, Burgio LD, Groomes TE, Cook EW 3rd, DeLuca SC, Miller NE. An operant approach to rehabilitation medicine: overcoming learned nonuse by shaping. J Exp Anal Behav. 1994 Mar;61(2):281-93. doi: 10.1901/jeab.1994.61-281.
Results Reference
background
Citation
Taub E: Somatosensory deafferentation research with monkeys: Implications for rehabilitation medicine. In Ince LP (ed.) Behavioral Psychology in Rehabilitation Medicine: Clinical Applications. New York: Williams Wilkins, 1980, 370-401
Results Reference
background
PubMed Identifier
8466415
Citation
Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.
Results Reference
background
Citation
Taub E, Pidikiti RD, DeLuca SC, Crago JE: Effects of motor restriction of an unimpaired upper extremity and training on improving functional tasks and altering brain/behaviors. In J. Toole (ed.), Imaging and Neurologic Rehabilitation. New York::Demos, 1996, 133-154.
Results Reference
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PubMed Identifier
27620374
Citation
Taub E, Wolf SL. Constraint Induced Movement Techniques To Facilitate Upper Extremity Use in Stroke Patients. Top Stroke Rehabil. 1997 Jan;3(4):38-61. doi: 10.1080/10749357.1997.11754128.
Results Reference
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PubMed Identifier
11389792
Citation
Taub E, Morris DM. Constraint-induced movement therapy to enhance recovery after stroke. Curr Atheroscler Rep. 2001 Jul;3(4):279-86. doi: 10.1007/s11883-001-0020-0.
Results Reference
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PubMed Identifier
27620372
Citation
Duncan PW. Synthesis of Intervention Trials To Improve Motor Recovery following Stroke. Top Stroke Rehabil. 1997 Jan;3(4):1-20. doi: 10.1080/10749357.1997.11754126.
Results Reference
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PubMed Identifier
12801434
Citation
Wolf SL, Blanton S, Baer H, Breshears J, Butler AJ. Repetitive task practice: a critical review of constraint-induced movement therapy in stroke. Neurologist. 2002 Nov;8(6):325-38. doi: 10.1097/01.nrl.0000031014.85777.76.
Results Reference
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PubMed Identifier
12732800
Citation
Clark PC, Shields CG, Aycock D, Wolf SL. Preliminary reliability and validity of a family caregiver conflict scale for stroke. Prog Cardiovasc Nurs. 2003 Spring;18(2):77-82, 92.
Results Reference
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PubMed Identifier
12817653
Citation
Butler AJ, Wolf SL. Transcranial magnetic stimulation to assess cortical plasticity: a critical perspective for stroke rehabilitation. J Rehabil Med. 2003 May;(41 Suppl):20-6. doi: 10.1080/16501960310010106.
Results Reference
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PubMed Identifier
14503435
Citation
Winstein CJ, Miller JP, Blanton S, Taub E, Uswatte G, Morris D, Nichols D, Wolf S. 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. doi: 10.1177/0888439003255511.
Results Reference
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PubMed Identifier
15222091
Citation
Aycock DM, Blanton S, Clark PC, Wolf SL. What is constraint-induced therapy? Rehabil Nurs. 2004 Jul-Aug;29(4):114-5, 121. doi: 10.1002/j.2048-7940.2004.tb00326.x. No abstract available.
Results Reference
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PubMed Identifier
15228805
Citation
Park SW, Butler AJ, Cavalheiro V, Alberts JL, Wolf SL. Changes in serial optical topography and TMS during task performance after constraint-induced movement therapy in stroke: a case study. Neurorehabil Neural Repair. 2004 Jun;18(2):95-105. doi: 10.1177/0888439004265113.
Results Reference
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PubMed Identifier
15261852
Citation
Wolf SL, Butler AJ, Campana GI, Parris TA, Struys DM, Weinstein SR, Weiss P. Intra-subject reliability of parameters contributing to maps generated by transcranial magnetic stimulation in able-bodied adults. Clin Neurophysiol. 2004 Aug;115(8):1740-7. doi: 10.1016/j.clinph.2004.02.027.
Results Reference
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PubMed Identifier
17077374
Citation
Wolf SL, Winstein CJ, Miller JP, Taub E, Uswatte G, Morris D, Giuliani C, Light KE, Nichols-Larsen D; EXCITE Investigators. 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. doi: 10.1001/jama.296.17.2095.
Results Reference
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PubMed Identifier
20814005
Citation
Wolf SL, Thompson PA, Winstein CJ, Miller JP, Blanton SR, Nichols-Larsen DS, Morris DM, Uswatte G, Taub E, Light KE, Sawaki L. The EXCITE stroke trial: comparing early and delayed constraint-induced movement therapy. Stroke. 2010 Oct;41(10):2309-15. doi: 10.1161/STROKEAHA.110.588723. Epub 2010 Sep 2.
Results Reference
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PubMed Identifier
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Citation
Wolf SL, Winstein CJ, Miller JP, Thompson PA, Taub E, Uswatte G, Morris D, Blanton S, Nichols-Larsen D, Clark PC. 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. doi: 10.1016/S1474-4422(07)70294-6.
Results Reference
derived

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Improving Arm Mobility and Use After Stroke

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