NCT00681434

Brief Summary

This randomized, single-blind study compares the effectiveness of bilateral training to unilateral training for individuals with moderate hemiparesis. We hypothesize that bilateral training will be superior to unilateral in the proximal extremity but not the distal one.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2 stroke

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
Last Updated

August 4, 2014

Status Verified

August 1, 2014

Enrollment Period

2.3 years

First QC Date

May 19, 2008

Last Update Submit

August 1, 2014

Conditions

StrokeHemiparesis

Keywords

strokeupper extremityhemiparesis

Outcome Measures

Primary Outcomes (2)

  • Motor Assessment Scale

    pre and post (week one and week 8)

  • Motor Status Scale

    pre and post, Week 0 and Week eight

Secondary Outcomes (1)

  • Reaching Performance Scale

    pre and post training (Week 0 and week 8)

Study Arms (2)

1

EXPERIMENTAL

bilateral training

Behavioral: bilateral upper extremity training

2

ACTIVE COMPARATOR

Unilateral training

Behavioral: Unilateral upper extremity training

Interventions

bilateral upper extremity trainingBEHAVIORAL

Bilateral symmetrical upper extremity training for proximal control for three hours per week for eight weeks.

1
Unilateral upper extremity trainingBEHAVIORAL

Unilateral upper extremity training for proximal extremity for three hours a week for eight weeks.

2

Eligibility Criteria

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

You may qualify if:

  • cortical or subcortical stroke
  • chronic condition (at least six months prior)
  • ability to follow 2-step commands
  • ability to give consent

You may not qualify if:

  • lesion in brain stem or cerebellum
  • visual field cut
  • neglect
  • uncontrolled hypertension
  • angina
  • COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Stoykov ME, Lewis GN, Corcos DM. Comparison of bilateral and unilateral training for upper extremity hemiparesis in stroke. Neurorehabil Neural Repair. 2009 Nov;23(9):945-53. doi: 10.1177/1545968309338190. Epub 2009 Jun 16.

    PMID: 19531608RESULT

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mary E Stoykov, PhD

    University of Illinois at Chicago Department of Kinesiology and Nutrition

    PRINCIPAL INVESTIGATOR

  • Daniel M Corcos, PhD

    University of Illinois at Chicago Department of Kinesiology and Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2008

First Posted

May 21, 2008

Study Start

May 1, 2005

Primary Completion

August 1, 2007

Last Updated

August 4, 2014

Record last verified: 2014-08