NCT00057018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2000

Longer than P75 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

September 26, 2016

Status Verified

May 1, 2011

Enrollment Period

4.9 years

First QC Date

March 26, 2003

Last Update Submit

September 23, 2016

Conditions

Cerebrovascular Accident

Keywords

strokecerebrovascular accidentupper extremityphysical therapyconstraint-induced therapy

Interventions

Constraint-induced movement therapyPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 9 months post cerebral infarct or 1 year post injury
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Southern California

Los Angeles, California, 9009-9006, United States

Location

University of Florida

Gainesville, Florida, 32610-0154, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7135, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Ohio State University

Columbus, Ohio, 43210-1234, United States

Location

Related Publications (20)

  • 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.

    PMID: 7243897BACKGROUND

  • 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.

    PMID: 2707361BACKGROUND

  • 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.

    PMID: 8169577BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 8466415BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 27620374BACKGROUND

  • 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.

    PMID: 11389792BACKGROUND

  • 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.

    PMID: 27620372BACKGROUND

  • 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.

    PMID: 12801434BACKGROUND

  • 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.

    PMID: 12732800BACKGROUND

  • 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.

    PMID: 12817653BACKGROUND

  • 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.

    PMID: 14503435BACKGROUND

  • 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.

    PMID: 15222091BACKGROUND

  • 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.

    PMID: 15228805BACKGROUND

  • 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.

    PMID: 15261852BACKGROUND

  • 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.

    PMID: 17077374RESULT

  • Schweighofer N, Ye D, Luo H, D'Argenio DZ, Winstein C. Long-term forecasting of a motor outcome following rehabilitation in chronic stroke via a hierarchical bayesian dynamic model. J Neuroeng Rehabil. 2023 Jun 29;20(1):83. doi: 10.1186/s12984-023-01202-y.

    PMID: 37386512DERIVED

  • 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.

    PMID: 20814005DERIVED

  • 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.

    PMID: 18077218DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Steven L Wolf, PhD/PT/FAPTA

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

March 26, 2003

First Posted

March 28, 2003

Study Start

April 1, 2000

Primary Completion

March 1, 2005

Study Completion

January 1, 2006

Last Updated

September 26, 2016

Record last verified: 2011-05

Locations

US(7)