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
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
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
NCT ID
NCT05360836
First Posted
April 26, 2022
Last Updated
April 29, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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
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The Effect of Motor Imagery in Patients With Radius Distal End Fracture
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