Distal Radius FractureNCT05360836
The Effect of Motor Imagery in Patients With Radius Distal End Fracture
A study testing Conservative treatment via telerehabilitation and Conservative treatmen + motor imagery in people with Distal Radius Fracture, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Conservative treatment via telerehabilitation and Conservative treatmen + motor imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Distal radius fracture and conservative treatment was decided
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Motor Imagery on Pain, Kinesiophobia, Functionality and Quality of Life in Patients With Radius Distal End Fracture
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.
Read more
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
- Conditions
- Distal Radius Fracture
- Being tested
- Conservative treatment via telerehabilitation, Conservative treatmen + motor imagery
- Keywords
- Fracture, Motor imagery, telerehabilitation, radius
- Medical subject headings
- Wrist Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatment via telerehabilitationOther
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.
Conservative treatmen + motor imageryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Conservative | Experimental | Conservative Treatment Program Receives: Other: Conservative treatment via telerehabilitation |
| Motor Imagery | Experimental | Conservative Treatment + Motor Imagery Program Receives: Other: Conservative treatment via telerehabilitation; Other: Conservative treatmen + motor imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 minutes
Functionality Level
Dash, The Patient-Based Wrist Assessment Questionnaire (HBEBD)
Measured: 10 minutes
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
Measured: 10 minutes
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
Measured: 1 minutes
Secondary outcomes (4)
Normal Range of Motion
Upper extremity joints and range of motion were evaluated
Measured: 5 minutes
the Recognize™
Use the Recognise App to quickly exercise your synapses on your device, wherever you are.
Measured: 10 minutes
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.
Measured: From the start of treatment until 8 week after the end of treatment
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Oct 2021
- Primary completion31 Jan 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Gizem KALAYCI, Istanbul University - Cerrahpasa
- Investigators
- Melike Gizem Kalaycı, PhD, Study director, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360836
- Sponsor's protocol ID
- IstanbulUniversityCerrahpasa
- Status last verified
- Jun 2024
- First submitted
- 26 Apr 2022
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kalayci MG, Analay Akbaba Y, Guven MF. The effect of motor imagery on functionality, pain, kinesiophobia, and quality of life in patients with distal radius fractures: A randomized controlled double-blind study. J Hand Ther. 2025 Oct-Dec;38(4):726-735. doi: 10.1016/j.jht.2025.02.018. Epub 2025 Apr 25.
PubMed 40287381
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motor Imagery on Pain, Kinesiophobia, Functionality and Quality of Life in Patients With Radius Distal End Fracture
- ClinicalTrials.gov ID
- NCT05360836
- Acronym / sponsor ID
- IstanbulUniversityCerrahpasa
- Conditions
- Distal Radius Fracture
- Keywords
- Fracture, Motor imagery, telerehabilitation, radius
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative | Experimental | Other: Conservative treatment via telerehabilitationConservative Treatment Program |
| Motor Imagery | Experimental | Other: Conservative treatment via telerehabilitation, Other: Conservative treatmen + motor imageryConservative Treatment + Motor Imagery Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Distal radius fracture and conservative treatment was decided
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative treatment via telerehabilitationPatients 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. | Other | Conservative, Motor Imagery |
| Conservative treatmen + motor imageryPatients 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. | Other | Motor Imagery |
Primary outcome
Muscle Strenght
Time frame: 3 minutes
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
Time frame: 10 minutes
Dash, The Patient-Based Wrist Assessment Questionnaire (HBEBD)
Kinesiofobia Level
Time frame: 10 minutes
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
Time frame: 1 minutes
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
4 secondary outcomes
Normal Range of Motion
Time frame: 5 minutes
the Recognize™
Time frame: 10 minutes
SF-12
Time frame: From the start of treatment until 8 week after the end of treatment
the Kinesthetic and Visual Imagery Questionnaire
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Derived from this study: PubMed 40287381Kalayci MG, Analay Akbaba Y, Guven MF. The effect of motor imagery on functionality, pain, kinesiophobia, and quality of life in patients with distal radius fractures: A randomized controlled double-blind study. J Hand Ther. 2025 Oct-Dec;38(4):726-735. doi: 10.1016/j.jht.2025.02.018. Epub 2025 Apr 25.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melike Gizem Kalaycı, PhD study director
Bahçeşehir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative treatment via telerehabilitation and Conservative treatmen + motor imagery in people with Distal Radius Fracture, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strenght (time frame: 3 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05360836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.