Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06215872
Other study ID # BAU-ALKAN-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2, 2021
Est. completion date January 10, 2024

Study information

Verified date January 2024
Source Bahçesehir University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

When determining the treatment method to be applied in distal radius fracture (DRF), in addition to clinical and radiological evaluation, the patient's age, physical activity level, cognitive status, severity of trauma, mechanism of injury and type of fracture are important factors in the treatment plan. Clinical studies show that physiotherapy is useful in improving the limitation of movement and pain in DRF. It shows that the active movement level is increased by decreasing the level. Rehabilitation after surgery proceeds similarly to conservative treatment. When exercise approaches in the literature are examined, it is seen that specific exercises for the wrist and forearm are recommended for treatment, but it has been reported that there are not enough studies to constitute evidence value. For decades, the skeletal muscles of the human body have been characterized as independent structures. However, recent research supports the "single muscle theory", contrary to this classical view. According to this theory, the fascia tissue that covers the entire body connects the muscles to each other in the form of chains, and the muscles in the chain work together in performing functional movements. These chains are called myofascial chains. Fascia tissue that creates all these connections; It consists of tightly arranged connective tissue and is structurally similar to tendons and ligaments. It surrounds organs, muscles, vessels and nerves, connects tissues and allows them to slide and move over each other. Past histological studies have reported that there are also contractile cells in the fascia structure. Although there are problems in rehabilitation after DRF that go beyond a single segment and affect the whole body; There is no study in the literature that uses the myofascial chain exercises approach in the treatment of these problems. In the light of all this information, the thesis study aims to ensure the active participation of the upper body muscles in the rehabilitation process with the DRUK program planned with myofascial chain exercises and in this way to improve the functional level obtained as a result of rehabilitation.


Description:

Clinical studies show that physiotherapy is useful in improving the limitation of movement in distal radius fractures and increases the level of active movement by reducing the level of pain. Providing functional restoration with physiotherapy not only increases the quality of life but also reduces the number of days patients cannot go to work. Rehabilitation after surgery proceeds similarly to conservative treatment. When exercise approaches in the literature are examined, it is seen that specific exercises for the wrist and forearm are recommended for treatment, but it has been reported that there are not enough studies to constitute evidence value. Due to the increased risk of prolonged immobilization and damaged tissues after surgery compared to closed reduction; If problems such as disuse atrophy, loss of proprioception and joint range of motion are taken into consideration, all upper extremity disorders may occur after surgery, including the elbow and shoulder joints, which are positioned together with the wrist and whose use is restricted. The following have been reported as early and late complications after surgical treatments: i)Complex regional pain syndrome, reflex sympathetic dystrophy, algodystrophy, compartment syndrome; ii) Tendon adhesion or rupture; iii)Nerve compression; iv) Post traumatic arthritis; v)Dupuytren's contracture. Although some of these complications are related to surgery, other complications are affected by processes involving the fascial system. For decades, the skeletal muscles of the human body have been characterized as independent structures. However, recent research supports the "single muscle theory", contrary to this classical view. According to this theory, the fascia tissue that covers the entire body connects the muscles to each other in the form of chains, and the muscles in the chain work together in performing functional movements. These chains are called myofascial chains. In cadaveric studies, mechanical force transfer along these connections has been demonstrated, and this connection has been tried to be explained with biotensegrite models. Due to this load transfer, all structures on the chain are affected by the forces or disorders that any structure in the myofascial chain is exposed to, and this is explained by the biotensivity theory. Fascia tissue that creates all these connections; It consists of tightly arranged connective tissue and is structurally similar to tendons and ligaments. It surrounds organs, muscles, vessels and nerves, connects tissues and allows them to slide and move over each other. Past histological studies have reported that there are also contractile cells in the fascia structure. Although there are problems in rehabilitation after distal radius fracture that go beyond a single segment and affect the whole body; There is no study in the literature that uses the myofascial chain exercises approach in the treatment of these problems. In the light of all this information, the thesis study aims to ensure the active participation of the upper body muscles in the rehabilitation process with the distal radius fracture program planned with myofascial chain exercises and in this way to improve the functional level obtained as a result of rehabilitation.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date January 10, 2024
Est. primary completion date December 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Being between the ages of 18-70 - Being able to establish written and verbal communication in Turkish - Post-Op rehabilitation after primary DRF surgery, at 4 weeks, post op at 6 weeks at the l latest - Fixation using volar plating and nailing method - Post-op, if instruments were left temporarily, these instruments should be removed before the study - No previous history of surgery involving the upper extremity - To have sufficient technological device usage skills and fast internet infrastructure to use video communication technologies without any problems - Having a device that provides the necessary equipment for video calling - Having a table and 6 m2 of space to allow exercise in the living area Exclusion Criteria: - Occurrence of one of the complex regional pain syndrome subtypes after fracture - History of any chronic systemic, rheumatological, neurological, vascular disease - History of traumatic injury to intact extremities and trunk in the last 6 months - Presence of pain complaints including spine and shoulder pain over 3 according to the Visual Analogue Scale - Those who use anti-inflammatory drugs - Presence of cognitive or psychological illness that will prevent cooperation

Study Design


Intervention

Other:
Therapeutic Exercises
Participants who have inclusion criterias after DRF reconstrontion pos-op 4. week will included this study. Certified Physiotherapist who have master of science degree and doctorate student will assessed them before and after treatment with face to face. Also exercise education will give face to face with same therapist. After that first sessions patients will progress their standardize or structered exercises pragram with telerehabilition during 4 weeks and 16 sessions. All sessions will be supervised with physiotherapist. End of study assessments will perform again with same therapist.

Locations

Country Name City State
Turkey Bahcesehir University Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Bahçesehir University Atlas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quick DASH (The Disabilities of the Arm, Shoulder and Hand) Quick-DASH is an 11-item questionnaire that questions a person's limitations in upper extremity problems. Pre treatment and end of study (4 weeks after from first assessment)
Secondary The Visual Analogue Scale (VAS) This scale scores from 0 to 10. Higher scores indicate worse pain. Pre treatment and end of study (4 weeks after from first assessment)
Secondary Hand Functional Index (HFI) The hand functional index scale consists of 9 items. Each item is scored between 0-3. It is calculated by adding the scores from all items separately for both hands. Pre treatment and end of study (4 weeks after from first assessment)
Secondary Michigan Hand Outcomes Questionnaire (MHQ) It is a survey that includes six subheadings from patients (pain, hand function, satisfaction with hand function, work performance, ADL and aesthetic satisfaction). Pre treatment and end of study (4 weeks after from first assessment)
Secondary Joint Range of Motion Measurement Test With Goniometer Joint range of motion evaluation was made with a goniometer device and flexion, extension, radial-ulnar deviation angles were evaluated. Pre treatment and end of study (4 weeks after from first assessment)
Secondary Hand Grip Strength Measurement Test With Hand Dynamometer During the test, the patient was in a sitting position and the force value was recorded by squeezing the device in the palm of the hand and not supporting the body with the elbow. Pre treatment and end of study (4 weeks after from first assessment)
Secondary Pinch Grip Strength With Pinch Meter The force value was recorded by the researcher, by holding the device from the indicator part and asking the subject to squeeze it between the thumb and index finger in a sitting position. Pre treatment and end of study (4 weeks after from first assessment)
Secondary Fingertip Dexterity and Gross Movement of the Hand With The Purdue Pegboard Test (PPT) With materials such as metal pipe beads and sequin beads inside the device; The subject was asked to perform the exercises against the clock in the order and ways specified in the guide. Pre treatment and end of study (4 weeks after from first assessment)
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06453447 - Prednisone for CRPS in Distal Radius Fracture N/A
Recruiting NCT06136286 - ORIF Distal Radius Blood Flow Restriction Therapy N/A
Not yet recruiting NCT06078371 - Opioid-Free Pain Treatment in Trauma Patients N/A
Not yet recruiting NCT05902442 - A Clinical Comparison of Patient-specific 3D Printed Splints Versus Conventional Splints in the Treatment of Distal Radius Fractures. N/A
Completed NCT02990052 - Conservative Treatment vs. Volar Plating of Distal Radius Fractures N/A
Withdrawn NCT00788190 - Treatment of Distal Radius Fractures in Elderly Patients N/A
Completed NCT06343467 - Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost? N/A
Recruiting NCT06046404 - Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department N/A
Not yet recruiting NCT06251206 - Impact of Early ADL Education on Outcomes Post DRF ORIF Phase 1
Completed NCT00654615 - Fixation of Unstable Distal Radius Fractures N/A
Completed NCT01937624 - Pediatric Distal Radius US Study
Completed NCT01007565 - Postoperative Pain After Volar Plating for Distal Radius Fractures Phase 2
Terminated NCT01859468 - A Study Comparing the Effect of Amorphous Calcium Carbonate (ACC) on Healing Time of Distal Radius Fractures Phase 1/Phase 2
Completed NCT01103297 - 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Phase 4
Completed NCT05942950 - Predicting Outcomes of Distal Radius Fractures: a Surgeon Survey
Suspended NCT01693094 - A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome N/A
Not yet recruiting NCT06235957 - Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation in Distal Radius Fractures N/A
Recruiting NCT06019585 - Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures N/A
Terminated NCT02802774 - Immobilization of Postoperative Distal Radius Fractures N/A
Enrolling by invitation NCT05086224 - Hematoma Block Versus Bier Block for Closed Fracture Reduction Early Phase 1