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Mirror Therapy in Pos Stroke Individuals

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mirror Therapy
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion criteria were age over 18 years, clinical diagnosis of chronic and unilateral stroke (greater than six months after injury), hemiparesis sequel in the upper limb, absence of severe cognitive impairment with scores for the Mini Mental State Examination (MMSE) greater than or equal to 24 points for the educated and 14 for uneducated 17 and good sitting balance, qualified with scores between 20 and 40 on the Berg Balance Scale (BBS)

Exclusion Criteria:

  • Those with other neurological diseases and associated physical or mental disabilities, stroke trauma, pain and joint contractures in the upper limb that prevented movement and the ones who missed therapy more than 3 times in a row were excluded

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group of Motor Patterns

    Group of Functional Activities

    Arm Description

    For the mirror therapy protocol applied to the Motor Standard, each patient was treated with 15 mirror therapy sessions, 3 times a week for a total duration of 50 minutes. There were 4 exercises of voluntary range of motion involving the extension and mass flexion of the fingers, adduction and abduction of the fingers, pronation and supination of the forearm and elbow extension with associated shoulder elevation.

    For the mirror therapy protocol applied to functional activities, four functional exercises were performed: fitting of pieces stimulating fine and thick gripping, stacking of cubes / cups and transfer of objects of different shapes and sizes. Each patient was treated with 15 mirror therapy sessions, 3 times a week with a total duration of 50 minutes

    Outcomes

    Primary Outcome Measures

    Fugl-Meyer Assessment Scale
    Sensory and motor Impairment in post-stroke subjects. Severity of motor damage. In this case, use only upper limb session (score 66)

    Secondary Outcome Measures

    Mini-mental state examination
    brief assessment of cognition
    Berg Balance Scale
    Assessment of the static, dynamic and anticipatory balance
    Intrinsic Motivation Inventory
    self-report measure of intrinsic motivation
    Functional Independence of measure
    Assessment of activities of daily living and social cognition

    Full Information

    First Posted
    May 20, 2017
    Last Updated
    August 7, 2017
    Sponsor
    Universidade Federal do Rio Grande do Norte
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03175237
    Brief Title
    Mirror Therapy in Pos Stroke Individuals
    Official Title
    Mirror Therapy: Technique Benefits in Different Motor Impairment in Post-stroke Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 10, 2014 (Actual)
    Primary Completion Date
    August 15, 2015 (Actual)
    Study Completion Date
    September 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Rio Grande do Norte

    4. Oversight

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

    5. Study Description

    Brief Summary
    To evaluate the benefits of Mirror Therapy (MT) and motivation in patients with different levels of post-stroke motor impairment with two different therapy protocols. This is a randomized uncontrolled blinded study, with 27 individuals in the chronic phase of stroke. Participants were randomized into two intervention groups: MT group with motor patterns of movement (MP, n=13) and MT group with specific functional activities (SA, n=14). Motor impairment assessments (Fugl-Meyer Assessment - FMA), motivation (Intrinsic Motivation Inventory) and functionality (Functional Independence Measure - FIM) were performed before and after treatment, and 3 months after the end of sessions (follow-up). In each intervention group,there were patients classified with mild, moderate or severe motor impairment, according to FMA. All participants performed 15 MT sessions, 3 times a week for 50 minutes each session.
    Detailed Description
    Objective: To evaluate the benefits of Mirror Therapy (MT) and motivation in patients with different levels of post-stroke motor impairment with two different therapy protocols. Methods: This is a randomized uncontrolled blinded study, with 27 individuals in the chronic phase of stroke. Participants were randomized into two intervention groups: MT group with motor patterns of movement (MP, n=13) and MT group with specific functional activities (SA, n=14). Motor impairment assessments (Fugl-Meyer Assessment - FMA), motivation (IntrinsicMotivationInventory) and functionality (Functional Independence Measure - FIM) were performed before and after treatment, and 3 months after the end of sessions (follow-up). In each intervention group,there were patients classified with mild, moderate or severe motor impairment, according to FMA. All participants performed 15 MT sessions, 3 times a week for 50 minutes each session.

    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
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group of Motor Patterns
    Arm Type
    Experimental
    Arm Description
    For the mirror therapy protocol applied to the Motor Standard, each patient was treated with 15 mirror therapy sessions, 3 times a week for a total duration of 50 minutes. There were 4 exercises of voluntary range of motion involving the extension and mass flexion of the fingers, adduction and abduction of the fingers, pronation and supination of the forearm and elbow extension with associated shoulder elevation.
    Arm Title
    Group of Functional Activities
    Arm Type
    Experimental
    Arm Description
    For the mirror therapy protocol applied to functional activities, four functional exercises were performed: fitting of pieces stimulating fine and thick gripping, stacking of cubes / cups and transfer of objects of different shapes and sizes. Each patient was treated with 15 mirror therapy sessions, 3 times a week with a total duration of 50 minutes
    Intervention Type
    Other
    Intervention Name(s)
    Mirror Therapy
    Primary Outcome Measure Information:
    Title
    Fugl-Meyer Assessment Scale
    Description
    Sensory and motor Impairment in post-stroke subjects. Severity of motor damage. In this case, use only upper limb session (score 66)
    Time Frame
    baseline, 8 weeks and 3 months (follow-up)
    Secondary Outcome Measure Information:
    Title
    Mini-mental state examination
    Description
    brief assessment of cognition
    Time Frame
    baseline
    Title
    Berg Balance Scale
    Description
    Assessment of the static, dynamic and anticipatory balance
    Time Frame
    baseline
    Title
    Intrinsic Motivation Inventory
    Description
    self-report measure of intrinsic motivation
    Time Frame
    baseline, 7 days and 14 days
    Title
    Functional Independence of measure
    Description
    Assessment of activities of daily living and social cognition
    Time Frame
    baseline, 8 weeks and 3 months (follow-up)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Inclusion criteria were age over 18 years, clinical diagnosis of chronic and unilateral stroke (greater than six months after injury), hemiparesis sequel in the upper limb, absence of severe cognitive impairment with scores for the Mini Mental State Examination (MMSE) greater than or equal to 24 points for the educated and 14 for uneducated 17 and good sitting balance, qualified with scores between 20 and 40 on the Berg Balance Scale (BBS) Exclusion Criteria: Those with other neurological diseases and associated physical or mental disabilities, stroke trauma, pain and joint contractures in the upper limb that prevented movement and the ones who missed therapy more than 3 times in a row were excluded
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Roberta O Cacho, PhD
    Organizational Affiliation
    Universidade Federal do Rio Grande do Norte
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Mirror Therapy in Pos Stroke Individuals

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