NCT05360836

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

April 26, 2022

Last Update Submit

June 9, 2024

Conditions

Keywords

FractureMotor imagerytelerehabilitationradius

Outcome Measures

Primary Outcomes (4)

  • 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.

    3 minutes

  • Functionality Level

    Dash, The Patient-Based Wrist Assessment Questionnaire (HBEBD)

    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

    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

    1 minutes

Secondary Outcomes (4)

  • Normal Range of Motion

    5 minutes

  • the Recognize™

    10 minutes

  • SF-12

    From the start of treatment until 8 week after the end of treatment

  • the Kinesthetic and Visual Imagery Questionnaire

    10 minutes

Study Arms (2)

Conservative

EXPERIMENTAL

Conservative Treatment Program

Other: Conservative treatment via telerehabilitation

Motor Imagery

EXPERIMENTAL

Conservative Treatment + Motor Imagery Program

Other: Conservative treatment via telerehabilitationOther: Conservative treatmen + motor imagery

Interventions

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.

ConservativeMotor Imagery

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.

Motor Imagery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Distal radius fracture and conservative treatment was decided

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melike Gizem Kalaycı

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Wrist FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and Injuries

Study Officials

  • Melike Gizem Kalaycı, PhD

    Bahçeşehir University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 26, 2022

First Posted

May 4, 2022

Study Start

October 1, 2021

Primary Completion

January 31, 2022

Study Completion

May 30, 2022

Last Updated

June 11, 2024

Record last verified: 2024-06

Locations