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Power-Assisted Therapeutic Electrical Stimulation to Upper Extremities (TES)

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
therapeutic electrical stimulation
Sponsored by
Fujita Health University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

10 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acute or subacute phase of stroke

Exclusion Criteria:

  • chronic phase of stroke

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 14, 2009
    Last Updated
    January 14, 2009
    Sponsor
    Fujita Health University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00823537
    Brief Title
    Power-Assisted Therapeutic Electrical Stimulation to Upper Extremities
    Acronym
    TES
    Official Title
    Power-Assisted Therapeutic Electrical Stimulation to Upper Extremities in Acute Stroke Patients. A Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    December 2010 (Anticipated)
    Study Completion Date
    February 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Fujita Health University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Power-assisted therapeutic electrical stimulation (TES) or conventional TES to upper extremities in acute stroke patients were performed in a randomized controlled trial. The changes in finger and hand function will be evaluated. The hypothesis is that a power-assisted TES is more effective than a conventional TES.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    therapeutic electrical stimulation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: acute or subacute phase of stroke Exclusion Criteria: chronic phase of stroke
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hitoshi Kagaya, MD
    Email
    hkagaya2@fujita-hu.ac.jp

    12. IPD Sharing Statement

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    Power-Assisted Therapeutic Electrical Stimulation to Upper Extremities

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