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Effect of Robotic Therapy on Upper Extremity With Stroke

Primary Purpose

the Effect of Virtual Reality on Stroke Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
robotic exercise therapy
conventional therapy
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for the Effect of Virtual Reality on Stroke Rehabilitation focused on measuring stroke, upper extremity, robot-assisted therapy, armeo

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Ischemic or hemorhagic hemiplegia Brunnstrom upper extremity motor stage ≥3 At least 3 months have passed Modified Ashworth Score ≤2 18-85 year old patients with diagnosis of stroke Exclusion Criteria: Aphasia Cognitive impairment mini mental test <24 deformity and / or contracture in the upper extremity Patients diagnosed with KBAS

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    conventional therapy

    robot-assisted therapy

    Arm Description

    20 sessions of conventional therapy was applied for 5 days a week for 4 weeks, 1 hour a day

    20 sessions of upper extremity robot-assisted therapy was applied for 4 weeks, 5 days a week, 30 minutes a day.

    Outcomes

    Primary Outcome Measures

    FMA-UE scale
    FMA-UE evaluates the hemiparetic arm's mobility, including reflexes, the presence of synergies, and each of the upper limb's independent motions, including grasp. The dysmetria, coordination, and velocity of the patient are also evaluated using items on this scale. It is intended to assess muscle strength, reflex actions, and movement control in the upper extremity following a stroke. It has 33 elements and accepts values ranging from 0 to 2. Scores under 31 suggest a weak upper extremity, scores between 32 and 47 show a restricted upper extremity, scores between 48 and 52 indicate a noteworthy upper extremity, and scores between 53 and 66 indicate a full upper extremity.
    FMA-UE scale
    FMA-UE evaluates the hemiparetic arm's mobility, including reflexes, the presence of synergies, and each of the upper limb's independent motions, including grasp. The dysmetria, coordination, and velocity of the patient are also evaluated using items on this scale. It is intended to assess muscle strength, reflex actions, and movement control in the upper extremity following a stroke. It has 33 elements and accepts values ranging from 0 to 2. Scores under 31 suggest a weak upper extremity, scores between 32 and 47 show a restricted upper extremity, scores between 48 and 52 indicate a noteworthy upper extremity, and scores between 53 and 66 indicate a full upper extremity.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 22, 2023
    Last Updated
    April 4, 2023
    Sponsor
    Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05815823
    Brief Title
    Effect of Robotic Therapy on Upper Extremity With Stroke
    Official Title
    The Effect of Virtual Reality Assisted Upper Extremity Robotic Therapy on Pain, Daily Living Activities and Functional Status in Patients With Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    January 1, 2017 (Actual)
    Study Completion Date
    January 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    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
    The purpose of this study is to determine how adding virtual reality assisted robotic treatment to traditional rehabilitation affects stroke patients' pain levels, functional status, and daily living activities.After conventional and robotic therapy Each patient was evaluated The Barthel Index (BI), the Fugl Meyer Assessment Upper Extremity (FMA-UE), and the Visual Analogue Scale (VAS) were used to assess the patients' pain, daily living activities, and upper extremity motor function.
    Detailed Description
    The purpose of this study is to determine how adding virtual reality assisted robotic treatment to traditional rehabilitation affects stroke patients' pain levels, functional status, and daily living activities. Materials and Methods: The study included 40 stroke patients. Two groups of patients were created. Group I also underwent 20 sessions of upper extremity robot-assisted therapy for 4 weeks, 5 days a week, for 30 minutes per session, in addition to receiving conventional therapy (5 days a week for 4 weeks, 1 hour each day). Group II only got traditional therapy. Each patient was assessed both before and after the procedure. The Barthel Index (BI), the Fugl Meyer Assessment Upper Extremity (FMA-UE), and the Visual Analogue Scale (VAS) were used to assess the patients' pain, daily living activities, and upper extremity motor function.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    the Effect of Virtual Reality on Stroke Rehabilitation
    Keywords
    stroke, upper extremity, robot-assisted therapy, armeo

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    conventional therapy
    Arm Type
    Experimental
    Arm Description
    20 sessions of conventional therapy was applied for 5 days a week for 4 weeks, 1 hour a day
    Arm Title
    robot-assisted therapy
    Arm Type
    Experimental
    Arm Description
    20 sessions of upper extremity robot-assisted therapy was applied for 4 weeks, 5 days a week, 30 minutes a day.
    Intervention Type
    Other
    Intervention Name(s)
    robotic exercise therapy
    Other Intervention Name(s)
    robotic exercise
    Intervention Description
    Functional exercise programs such as collecting rain in a glass, grating vegetables, goalkeeper, cleaning the stove, watering flowers, wiping windows, catching fish, and exploring landscapes were applied by robotic games to the patients
    Intervention Type
    Other
    Intervention Name(s)
    conventional therapy
    Intervention Description
    streching, range of motion, strengthening, balance and walking exercise
    Primary Outcome Measure Information:
    Title
    FMA-UE scale
    Description
    FMA-UE evaluates the hemiparetic arm's mobility, including reflexes, the presence of synergies, and each of the upper limb's independent motions, including grasp. The dysmetria, coordination, and velocity of the patient are also evaluated using items on this scale. It is intended to assess muscle strength, reflex actions, and movement control in the upper extremity following a stroke. It has 33 elements and accepts values ranging from 0 to 2. Scores under 31 suggest a weak upper extremity, scores between 32 and 47 show a restricted upper extremity, scores between 48 and 52 indicate a noteworthy upper extremity, and scores between 53 and 66 indicate a full upper extremity.
    Time Frame
    baseline
    Title
    FMA-UE scale
    Description
    FMA-UE evaluates the hemiparetic arm's mobility, including reflexes, the presence of synergies, and each of the upper limb's independent motions, including grasp. The dysmetria, coordination, and velocity of the patient are also evaluated using items on this scale. It is intended to assess muscle strength, reflex actions, and movement control in the upper extremity following a stroke. It has 33 elements and accepts values ranging from 0 to 2. Scores under 31 suggest a weak upper extremity, scores between 32 and 47 show a restricted upper extremity, scores between 48 and 52 indicate a noteworthy upper extremity, and scores between 53 and 66 indicate a full upper extremity.
    Time Frame
    after treatment (1 month)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Ischemic or hemorhagic hemiplegia Brunnstrom upper extremity motor stage ≥3 At least 3 months have passed Modified Ashworth Score ≤2 18-85 year old patients with diagnosis of stroke Exclusion Criteria: Aphasia Cognitive impairment mini mental test <24 deformity and / or contracture in the upper extremity Patients diagnosed with KBAS

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Effect of Robotic Therapy on Upper Extremity With Stroke

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