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Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental group
Control group
traditional rehabilitation
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Hand, Paralysis, Stroke

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • acute phase of stroke
  • first stroke episode.
  • no history of peripheral nerve injury or musculoskeletal disease
  • no contracture of the affected wrist or fingers (Modified Ashworth<3)
  • no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months prior to the start of this study.
  • paralysis of the wrist and fingers

Exclusion Criteria:

  • unstable medical disorders, active Complex Regional Pain Syndrome (CRPS) severe spatial neglect, aphasia, or cognitive problems.
  • scored greater than 4 points on the Beck Depression Inventory (BDI)
  • more than 30 points in the State Trait Anxiety Inventory (STAI)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental group

    Control group

    Arm Description

    Robotic device Gloreha (Gloreha, Idrogenet, Italy) and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).

    Physiotherapy, occupational therapy and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).

    Outcomes

    Primary Outcome Measures

    Change from National Institutes of Health Stroke Scale (NIHSS)

    Secondary Outcome Measures

    Change from Visual analogue scale (VAS)
    Change from Barthel Index (BI)
    Change from Modified Ashworth Scale (MAS)
    Change from Disabilities of the Arm, Shoulder and Hand (quickDASH)

    Full Information

    First Posted
    March 5, 2016
    Last Updated
    March 11, 2016
    Sponsor
    Fondazione Don Carlo Gnocchi Onlus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02711787
    Brief Title
    Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke
    Official Title
    Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fondazione Don Carlo Gnocchi Onlus

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Among robotic devices, Gloreha, with its compliant mechanical transmission, may represent an easily applied innovative solution to rehabilitation, because the hand can perform grasp and release activities wearing the device by mean of a flexible and light orthosis. Our objective on this research was to the robotic assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis.
    Detailed Description
    The investigators evaluated the effectiveness of a robotic-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis. A randomized controlled trial. The experimental group received a passive mobilization of the hand through the robotic device Gloreha and control group received a PT and OT for 3 consecutive weeks (3 days/week) in addition to traditional rehabilitation. Outcomes included the National Institutes of Health Stroke Scale (NIHSS), Modified Ashworth Scale (MAS), Barthel index (BI), Motricity index (MI), short version of the Disabilities of the Arm, Shoulder and Hand (quickDASH), and the Visual Analogue Scale (VAS) measurements. All measures were collected at baseline and end of the intervention (3 weeks).

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Robotic device Gloreha (Gloreha, Idrogenet, Italy) and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Physiotherapy, occupational therapy and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).
    Intervention Type
    Device
    Intervention Name(s)
    Experimental group
    Intervention Description
    Robotic assisted passive mobilization (Gloreha, Idrogenet, Italy) and traditional rehabilitation.
    Intervention Type
    Device
    Intervention Name(s)
    Control group
    Intervention Description
    Physiotherapy and occupational therapy.
    Intervention Type
    Device
    Intervention Name(s)
    traditional rehabilitation
    Intervention Description
    Assisted stretching, shoulder and arm exercises, and functional reaching tasks
    Primary Outcome Measure Information:
    Title
    Change from National Institutes of Health Stroke Scale (NIHSS)
    Time Frame
    baseline, immediately post-intervention (3 weeks).
    Secondary Outcome Measure Information:
    Title
    Change from Visual analogue scale (VAS)
    Time Frame
    baseline, immediately post-intervention (3 weeks).
    Title
    Change from Barthel Index (BI)
    Time Frame
    baseline, immediately post-intervention (3 weeks).
    Title
    Change from Modified Ashworth Scale (MAS)
    Time Frame
    baseline, immediately post-intervention
    Title
    Change from Disabilities of the Arm, Shoulder and Hand (quickDASH)
    Time Frame
    baseline, immediately post-intervention (3 weeks).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: acute phase of stroke first stroke episode. no history of peripheral nerve injury or musculoskeletal disease no contracture of the affected wrist or fingers (Modified Ashworth<3) no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months prior to the start of this study. paralysis of the wrist and fingers Exclusion Criteria: unstable medical disorders, active Complex Regional Pain Syndrome (CRPS) severe spatial neglect, aphasia, or cognitive problems. scored greater than 4 points on the Beck Depression Inventory (BDI) more than 30 points in the State Trait Anxiety Inventory (STAI)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    JORGE H VILLAFAÑE, PhD
    Organizational Affiliation
    IRCCS Don Gnocchi Foundation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke

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