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Upper Limb Robotic Rehabilitation After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Robotic passive mobilization
Sponsored by
Università degli Studi di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • first event of cerebrovascular stroke; unilateral paresis; ability to remain in sitting position

Exclusion Criteria:

  • bilateral impairment; cognitive or behaviorql dysfunctions; finger flexion contracture; degenerative or non degenerative neurological conditions; refusal or inability to provide informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Passive mobilization

    Arm Description

    Upper limb passive mobilization assisted with robotic device

    Outcomes

    Primary Outcome Measures

    Forearm perfusion
    Amount of total hemoglobin circulating in the forearm muscle tissues.
    Muscle tone
    The tone of the muscle assessed with Modified Ashworth Scale

    Secondary Outcome Measures

    Full Information

    First Posted
    August 3, 2017
    Last Updated
    August 7, 2017
    Sponsor
    Università degli Studi di Brescia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03243123
    Brief Title
    Upper Limb Robotic Rehabilitation After Stroke
    Official Title
    Passive Mobilization With Robotic Assistance Improve Hemiparetic Upper Limb Circulation and Functional Status in Stroke Survivors.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2014 (Actual)
    Primary Completion Date
    November 15, 2014 (Actual)
    Study Completion Date
    December 23, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Università degli Studi di Brescia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a single arm study aimed at evaluating the acute effects induced by a single session of robot-assisted passive hand mobilization on local perfusion and upper limb function in post-stroke hemiparetic patients. Twenty-three participants with subacute or chronic stroke received 20 min passive mobilization of the paretic hand with robotic assistance. After the intervention, significant improvements were found in forearm perfusion, muscle tone significantly decreased and subjects reported decreased upper limb heaviness, stiffness and pain. This study supports novel evidence that hand robotic assistance promotes local forearm circulation, may help in the management of spasticity and acutely alleviates reported symptoms of heaviness, stiffness and pain in subjects with post-stroke hemiparesis.

    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
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Passive mobilization
    Arm Type
    Experimental
    Arm Description
    Upper limb passive mobilization assisted with robotic device
    Intervention Type
    Device
    Intervention Name(s)
    Robotic passive mobilization
    Intervention Description
    The intervention was performed using the Gloreha (Idrogenet, Italy) robotic system. The system consists of a soft exoskeleton similar to a glove. Passive hand joints mobilization is provided by a hydraulic system. Each patient underwent a session of 20 min passive mobilization of the paretic hand.
    Primary Outcome Measure Information:
    Title
    Forearm perfusion
    Description
    Amount of total hemoglobin circulating in the forearm muscle tissues.
    Time Frame
    30 minutes
    Title
    Muscle tone
    Description
    The tone of the muscle assessed with Modified Ashworth Scale
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: first event of cerebrovascular stroke; unilateral paresis; ability to remain in sitting position Exclusion Criteria: bilateral impairment; cognitive or behaviorql dysfunctions; finger flexion contracture; degenerative or non degenerative neurological conditions; refusal or inability to provide informed consent.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29094043
    Citation
    Gobbo M, Gaffurini P, Vacchi L, Lazzarini S, Villafane J, Orizio C, Negrini S, Bissolotti L. Hand Passive Mobilization Performed with Robotic Assistance: Acute Effects on Upper Limb Perfusion and Spasticity in Stroke Survivors. Biomed Res Int. 2017;2017:2796815. doi: 10.1155/2017/2796815. Epub 2017 Sep 28.
    Results Reference
    derived

    Learn more about this trial

    Upper Limb Robotic Rehabilitation After Stroke

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