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The Effect of Motor Imagery in Patients With Radius Distal End Fracture

Primary Purpose

Distal Radius Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conservative treatment via telerehabilitation
Conservative treatmen + motor imagery
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring Distal Radius Fracture, Motor imagery, telerehabilitation, physiotherapy

Eligibility Criteria

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

Inclusion Criteria:

  • Distal radius fracture and conservative treatment was decided

Exclusion Criteria:

  • Bilateral fracture
  • Cases with unstable, comminuted or complicated fractures, fractures associated with malignant conditions, presence of infection, cognitive impairment or inability to perceive verbal commands, and bilateral fractures will not be included in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Arm Description

    Conservative Treatment Program

    Conservative Treatment + Motor Imagery Program

    Outcomes

    Primary Outcome Measures

    Muscle Strenght
    A dynamometer was used to evaluate muscle strength. Muscle strength was evaluated in the following muscles, each measurement was made three times and the maximum was taken.
    Functionality Level
    Dash, The Patient-Based Wrist Assessment Questionnaire (HBEBD)
    Kinesiofobia Level
    Kinesiophobia, defined as an excessive, irrational, and debilitating fear of physical movement and activity resulting from a feeling of vulnerability due to painful injury or reinjury" is found to be a central factor in the process of pain developing from acute to chronic stages .Tampa scale
    Pain Level
    Purpose and application of the test: The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically into numericals. Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line or by placing a point or pointing on this line. Rest, activity and night were evaluated in three different time periods

    Secondary Outcome Measures

    Normal Range of Motion
    Upper extremity joints and range of motion were evaluated
    Moberg Pick Up Test
    Moberg pickup test (MPUT) is a standardized test to assess for hand dexterity and functional sensibility. It is a timed test first used in neuro-rehabilitation to evaluate hand motor activity. It is simple and quick to administer, easy to replicate and inexpensive to acquire.
    the Recognize™
    Use the Recognise App to quickly exercise your synapses on your device, wherever you are.
    SF-12
    The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
    the Kinesthetic and Visual Imagery Questionnaire
    The KVIQ assesses on a five-point ordinal scale the clarity of the image (visual: V subscale) and the intensity of the sensations (kinesthetic: K subscale) that the subjects are able to imagine from the first-person perspective.

    Full Information

    First Posted
    April 26, 2022
    Last Updated
    April 29, 2022
    Sponsor
    Istanbul University - Cerrahpasa (IUC)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05360836
    Brief Title
    The Effect of Motor Imagery in Patients With Radius Distal End Fracture
    Official Title
    The Effect of Motor Imagery on Pain, Kinesiophobia, Functionality and Quality of Life in Patients With Radius Distal End Fracture
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2022 (Anticipated)
    Primary Completion Date
    August 31, 2022 (Anticipated)
    Study Completion Date
    September 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University - Cerrahpasa (IUC)

    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
    Distal Radius End Fracture (DRC) is one of the most common fractures among all extremity fractures and wrist fractures . Pain, edema and functional loss are common findings in patients, and the physiotherapy program should be well planned from an early time. However, although there are different physiotherapy and rehabilitation applications in the treatment of DRC, there is not enough information about the effectiveness of the applications when the evidence-based studies are examined. The aim of this study is to investigate the effect of motor imagery added to conventional treatment versus conventional treatment with telerehabilitation in patients with distal radius end fracture. Motor imagery is defined as the mental presentation of voluntary movement without body movement. It is an application that does not require cost and it is a training that can be easily applied in rehabilitation programs. Telerehabilitation is important in the management of patients in the acute phase of the disease, as well as in the remote management of individuals with chronic health problems. Cases who applied to Istanbul University-Cerrahpaşa Medical Faculty Orthopedics and Traumatology Clinic and were referred to Istanbul University-Cerrahpaşa Physiotherapy and Rehabilitation Department will be included in the study. Few studies have examined the effects of motor imagery on pain, kinesiophobia, and functionality in musculoskeletal injuries. Studies on the effects of motor imagery on different patient groups are needed. Therefore, in our study, the effect of motor imagery training applied with the telerehabilitation method on pain, kinesiophobia and functionality in patients with distal radius end fracture will be examined. Sociodemographic data form of all subjects who volunteered to participate in the study; Age, gender, height, weight, pain, dominant extremity, and the type of fracture will be questioned. In addition, pain intensity is measured with a visual analog scale, normal joint movement measurement (wrist flexion, extension, ulnar and radial deviation, and forearm supination and pronation) with goniometer, hand grip strength with "Hydraulic hand dynamometer" , finger grip strength "Hydraulic Finger Dynamometer", kinesiophobia Tampa Kinesiophobia Scale, functionality "Arm, Shoulder and Hand Injury Questionnaire in Turkish (Disabilities of Arm, Shoulder and Hand-Turkish - DASH-T and The Patient-Based Wrist Assessment Questionnaire (HBEBD), with the fine dexterity Moberg Pick Up test, the motor imagery ability with the Recognize™ phone app and the Kinesthetic and Visual Imagery Questionnaire, quality of life will be evaluated with SF-12. After the initial evaluation, the treatment program was started. Advances in the treatment method specific to the groups they belong to are explained in detail below. Treatment: After the distal radius end fracture, after 6 weeks of plaster application, after the first evaluation to be made in the clinic after the plaster was removed, in the next session, after patient education, conventional treatment was applied to the cases in Group 1, 3 days a week as stated below. Group 2: Conservative Treatment + Motor Imagery Program Patients in this group will have motor imagery in addition to conservative treatment. The patients in this group will first be given a motor imagery introductory session. According to the results of the observation and evaluation made by the physiotherapist before the treatment, the function of the patients

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Distal Radius Fracture
    Keywords
    Distal Radius Fracture, Motor imagery, telerehabilitation, physiotherapy

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm Description
    Conservative Treatment Program
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    Conservative Treatment + Motor Imagery Program
    Intervention Type
    Other
    Intervention Name(s)
    Conservative treatment via telerehabilitation
    Intervention Description
    Patients will do their exercises in the form of a WhatsApp video call or a Zoom video call. Contrast bath, massage application for 5 minutes, passive, active assistive normal range of motion. Ice application. After 4 weeks strenghtening exercise. The treatment time 8 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Conservative treatmen + motor imagery
    Intervention Description
    Patients will do their exercises in the form of a WhatsApp video call or a Zoom video call. Contrast bath, 5-minute massage, passive, active auxiliary normal range of motion. Ice application. Strengthening exercise after 4 weeks. The duration of treatment is 8 weeks. This group applies motor images for a maximum of 5 minutes. They will implement functionality-based motor images.
    Primary Outcome Measure Information:
    Title
    Muscle Strenght
    Description
    A dynamometer was used to evaluate muscle strength. Muscle strength was evaluated in the following muscles, each measurement was made three times and the maximum was taken.
    Time Frame
    3 minutes
    Title
    Functionality Level
    Description
    Dash, The Patient-Based Wrist Assessment Questionnaire (HBEBD)
    Time Frame
    10 minutes
    Title
    Kinesiofobia Level
    Description
    Kinesiophobia, defined as an excessive, irrational, and debilitating fear of physical movement and activity resulting from a feeling of vulnerability due to painful injury or reinjury" is found to be a central factor in the process of pain developing from acute to chronic stages .Tampa scale
    Time Frame
    10 minutes
    Title
    Pain Level
    Description
    Purpose and application of the test: The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically into numericals. Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line or by placing a point or pointing on this line. Rest, activity and night were evaluated in three different time periods
    Time Frame
    1 minutes
    Secondary Outcome Measure Information:
    Title
    Normal Range of Motion
    Description
    Upper extremity joints and range of motion were evaluated
    Time Frame
    5 minutes
    Title
    Moberg Pick Up Test
    Description
    Moberg pickup test (MPUT) is a standardized test to assess for hand dexterity and functional sensibility. It is a timed test first used in neuro-rehabilitation to evaluate hand motor activity. It is simple and quick to administer, easy to replicate and inexpensive to acquire.
    Time Frame
    5 minutes
    Title
    the Recognize™
    Description
    Use the Recognise App to quickly exercise your synapses on your device, wherever you are.
    Time Frame
    10 minutes
    Title
    SF-12
    Description
    The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
    Time Frame
    From the start of treatment until 8 week after the end of treatment
    Title
    the Kinesthetic and Visual Imagery Questionnaire
    Description
    The KVIQ assesses on a five-point ordinal scale the clarity of the image (visual: V subscale) and the intensity of the sensations (kinesthetic: K subscale) that the subjects are able to imagine from the first-person perspective.
    Time Frame
    10 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Distal radius fracture and conservative treatment was decided Exclusion Criteria: Bilateral fracture Cases with unstable, comminuted or complicated fractures, fractures associated with malignant conditions, presence of infection, cognitive impairment or inability to perceive verbal commands, and bilateral fractures will not be included in the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Melike Gizem Kalaycı, PhdC
    Phone
    05550720291
    Email
    melikegizem@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    The Effect of Motor Imagery in Patients With Radius Distal End Fracture

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