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The Efficiency of Robotic Hand Exoskeleton System in Stroke Patients

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional physiotherapy
Robotic Hand Exoskeleton System
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Hemiplegia, Exoskeleton Device, Muscle Spasticity, Quality of life

Eligibility Criteria

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

Inclusion Criteria: Being diagnosed with stroke by a neurologist At least 3 months have passed after the stroke Mini Mental State Examination score of at least 24 To be able to maintain sitting balance during working with the robot, Having full range of motion in the metacarpophalangeal (MCP), proximal interphalangeal (PIF) and distal interphalangeal (DIF) joints, Spasticity in finger flexor and extensor muscles ≤ 3 according to the Modified Ashworth Scale (MAS) Being between the ages of 35-85 Exclusion Criteria: Other neurological or orthopedic problems that may affect upper extremity function, Cardiovascular vulnerability (severe uncontrolled hypertension, severe coronary artery disease, unstable angina) Behavioral and cognitive conditions that affect treatment and make compliance difficult Having botulinum toxin procedure in the last 6 months Cardiac pacemakers Those with skin ulcers Pregnancy History of metastatic cancer

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Control group

    Intervention group

    Arm Description

    Participants in this group will receive a conventional physiotherapy program 3 times a week for 5 weeks, each session lasting 1 hour.

    Participants in this group will receive Robotic Hand Exoskeleton System for 10 minutes in addition to 50 minutes of conventional physiotherapy 3 times a week for 5 weeks.

    Outcomes

    Primary Outcome Measures

    Frenchay Arm Test
    It is a scale that evaluates the motor control skills and functions of the upper extremities of patients in a practical way and takes less than 3 minutes to perform. The patient is asked to perform 5 tasks based on activities of daily living in a sitting position with hands on the table. The maximum score on the scale is 5, with 1 point for each successful task. (The tasks the patient is asked to do are; Fixing the ruler, Holding a cylinder, Lifting the glass, Attaching the latch to the bar, Combing hair)

    Secondary Outcome Measures

    modified ashworth scale
    The modified Ashworth scale is designed to measure the resistance encountered when moving the limb passively at full range of motion. A value of 0 indicates normal muscle tone and 4 indicates the presence of intense spasticity.
    Upper Limb Motor Activity Diary-28
    The Upper Extremity Motor Activity Diary-28 is a scale consisting of 28 questions that measure the amount of use of the affected upper extremity in daily activities and the quality of the activity when used, and each question is scored between 0-5. Self-care activities, some housework and some activities that can be done in community life are questioned.
    Stroke impact scale version 3.0
    It was developed in 1999 to assess the quality of life and functional independence of post-stroke patients and consists of 59 questions with 8 sub-headings: strength, memory and memory, emotion, communication, activity of daily living, mobility, hand function, social participation. All questions are used to assess the difficulties experienced by the patient in the last week. The evaluation is based on 5 points. In addition to 59 questions in 8 sub-sections, it also includes a visual analog scale (0: No improvement, 100: Complete recovery) in which the patient's perception of global recovery after stroke is evaluated with 0-100 points. The score of all subcategories is summed, and the higher the total score obtained from the scale, the better the quality of life of the patients.

    Full Information

    First Posted
    July 16, 2023
    Last Updated
    July 16, 2023
    Sponsor
    Marmara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05958628
    Brief Title
    The Efficiency of Robotic Hand Exoskeleton System in Stroke Patients
    Official Title
    The Efficiency of Robotic Hand Exoskeleton System in Stroke Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 7, 2023 (Anticipated)
    Primary Completion Date
    November 17, 2023 (Anticipated)
    Study Completion Date
    November 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Marmara University

    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 aim of our study is to investigate the effects of the robotic hand exoskeleton, on the spasticity, motor control skills, level of daily living activity, quality of life and functional independence of stroke patients.
    Detailed Description
    Stroke is a condition that occurs as a result of an ischemic or hemorrhagic intracranial vascular event, is the third leading cause of death in the world and can lead to disability. Depending on the localization of brain damage after stroke, it is possible to talk about different prognoses and therefore different functional losses in the lower extremities, upper extremities and hand and wrist. Today, various neurophysiological approaches, exercise strategies, electrotherapy modalities and assistive devices are used in the rehabilitation program suitable for the patient after stroke. In addition to these, robot-assisted therapy is gaining a place as an innovative approach in stroke rehabilitation with the developments in technology. Robot-assisted therapy is thought to both facilitate and intensify treatment after stroke and increase motor development. The normal functions of the hand, which has many abilities and a complex structure, is extremely important to lead a free and active life. When the literature is examined, the success rate in the recovery of skills and functional recovery of the hand in stroke rehabilitation is low compared to the lower extremity and shoulder joint. More interventions are needed to increase the functional recovery of the hand. Studies should be conducted on robot-assisted treatment methods that allow active and passive exercises in the hand after stroke and contribute to neuroplasticity with an intensified and standardized program. Our aim in this study is to investigate the efficacy of the Robotic Hand Exoskeleton System developed at Marmara University in order to reduce the physiotherapy process and increase the responses of patients who have partially lost their hand functions due to stroke and need rehabilitation in stroke patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Stroke, Hemiplegia, Exoskeleton Device, Muscle Spasticity, Quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two groups; one group will receive conventional physiotherapy and one group will be operated with robotic hand exoskeleton system in addition to conventional physiotherapy.
    Masking
    Outcomes Assessor
    Masking Description
    The outcome assessment will be performed by a investigator who was blinded to group allocation.
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    Participants in this group will receive a conventional physiotherapy program 3 times a week for 5 weeks, each session lasting 1 hour.
    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Participants in this group will receive Robotic Hand Exoskeleton System for 10 minutes in addition to 50 minutes of conventional physiotherapy 3 times a week for 5 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Conventional physiotherapy
    Intervention Description
    The treatment program was designed in line with the patients' compliance, functional capacities and rehabilitation goals as neurodevelopmental therapy based on the ability to adapt to change, reorganization and healing in the brain by focusing on neuroplasticity from neurodevelopmental treatment approaches; Proprioceptive neuromuscular facilitation techniques to increase selective and voluntary movement; functional exercises to increase motor control skills, stretching exercises for spasticity and neuromuscular electrical stimulation. The control group received conventional physiotherapy exercises for 45 minutes and neuromuscular electrical stimulation for 15 minutes.
    Intervention Type
    Other
    Intervention Name(s)
    Robotic Hand Exoskeleton System
    Intervention Description
    In the treatment applications with the robotic hand exoskeleton system, which is designed to accelerate the healing process of patients in need of hand rehabilitation, to gain motor skills, to provide strength training and to increase participation in treatment, the patient will be asked to allow the system to move the hand at adjusted angles for 10 minutes and to accompany this movement. In the applications, while the patient is sitting comfortably and safely, the patient will be asked to place the stroke-affected hand into the system. The hand of patients who may have difficulty due to the functional status of the upper extremity and the severity of spasticity will be placed with the help of the physiotherapist. The physiotherapist will be with the patient throughout the application.
    Primary Outcome Measure Information:
    Title
    Frenchay Arm Test
    Description
    It is a scale that evaluates the motor control skills and functions of the upper extremities of patients in a practical way and takes less than 3 minutes to perform. The patient is asked to perform 5 tasks based on activities of daily living in a sitting position with hands on the table. The maximum score on the scale is 5, with 1 point for each successful task. (The tasks the patient is asked to do are; Fixing the ruler, Holding a cylinder, Lifting the glass, Attaching the latch to the bar, Combing hair)
    Time Frame
    5 weeks
    Secondary Outcome Measure Information:
    Title
    modified ashworth scale
    Description
    The modified Ashworth scale is designed to measure the resistance encountered when moving the limb passively at full range of motion. A value of 0 indicates normal muscle tone and 4 indicates the presence of intense spasticity.
    Time Frame
    5 weeks
    Title
    Upper Limb Motor Activity Diary-28
    Description
    The Upper Extremity Motor Activity Diary-28 is a scale consisting of 28 questions that measure the amount of use of the affected upper extremity in daily activities and the quality of the activity when used, and each question is scored between 0-5. Self-care activities, some housework and some activities that can be done in community life are questioned.
    Time Frame
    5 weeks
    Title
    Stroke impact scale version 3.0
    Description
    It was developed in 1999 to assess the quality of life and functional independence of post-stroke patients and consists of 59 questions with 8 sub-headings: strength, memory and memory, emotion, communication, activity of daily living, mobility, hand function, social participation. All questions are used to assess the difficulties experienced by the patient in the last week. The evaluation is based on 5 points. In addition to 59 questions in 8 sub-sections, it also includes a visual analog scale (0: No improvement, 100: Complete recovery) in which the patient's perception of global recovery after stroke is evaluated with 0-100 points. The score of all subcategories is summed, and the higher the total score obtained from the scale, the better the quality of life of the patients.
    Time Frame
    5 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Being diagnosed with stroke by a neurologist At least 3 months have passed after the stroke Mini Mental State Examination score of at least 24 To be able to maintain sitting balance during working with the robot, Having full range of motion in the metacarpophalangeal (MCP), proximal interphalangeal (PIF) and distal interphalangeal (DIF) joints, Spasticity in finger flexor and extensor muscles ≤ 3 according to the Modified Ashworth Scale (MAS) Being between the ages of 35-85 Exclusion Criteria: Other neurological or orthopedic problems that may affect upper extremity function, Cardiovascular vulnerability (severe uncontrolled hypertension, severe coronary artery disease, unstable angina) Behavioral and cognitive conditions that affect treatment and make compliance difficult Having botulinum toxin procedure in the last 6 months Cardiac pacemakers Those with skin ulcers Pregnancy History of metastatic cancer
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fatma Öztürk, Msc
    Phone
    +905454052621
    Email
    bayrakfatos@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Özge Keniş Coşkun, assoc.prof
    Email
    ozge.kenis@marmara.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fatma Öztürk, Msc
    Organizational Affiliation
    Marmara University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Gönül Acar, assoc.prof
    Organizational Affiliation
    Marmara University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Efficiency of Robotic Hand Exoskeleton System in Stroke Patients

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