Distal Radius FracturesNCT06215872
Effectiveness of Structured Myofacial Chain Exercises After Distal Radius Fracture
A study testing Therapeutic Exercises in people with Distal Radius Fractures, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Therapeutic Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2021to 10 Jan 2024
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Structured Myofacial Chain Exercise Training Applied in the Early Period After Distal Radius Fracture
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.
Read the detailed 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.
- Conditions
- Distal Radius Fractures
- Being tested
- Therapeutic Exercises
- Keywords
- Tele-Health, Exercise, Physical Therapy And Rehabilitation, Distal Radius Fractures
- Medical subject headings
- Wrist Fractures, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Upper Extremity Exercises Group | Active comparator | Participants will treated exercises with focused on upper extremity especially wrist muscles. Receives: Other: Therapeutic Exercises |
| Myofascial Chains Exercises Group | Experimental | Participants will treated exercises with focused on whole body especilly myofascial chains. Receives: Other: Therapeutic Exercises |
| Control Group | No intervention | Participants will do any exercises. They will join only assessment sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre treatment and end of study (4 weeks after from first assessment)
Secondary outcomes (7)
The Visual Analogue Scale (VAS)
This scale scores from 0 to 10. Higher scores indicate worse pain.
Measured: Pre treatment and end of study (4 weeks after from first assessment)
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.
Measured: Pre treatment and end of study (4 weeks after from first assessment)
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).
Measured: Pre treatment and end of study (4 weeks after from first assessment)
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.
Measured: Pre treatment and end of study (4 weeks after from first assessment)
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.
Measured: Pre treatment and end of study (4 weeks after from first assessment)
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.
Measured: Pre treatment and end of study (4 weeks after from first assessment)
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.
Measured: Pre treatment and end of study (4 weeks after from first assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start2 Jun 2021
- Primary completion15 Dec 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- 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
- Model description
- Prospective Randomized Control Single-Blind Study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Collaborators
- Atlas University
- Responsible party
- Principal investigator, Sebnem Nur Alkan, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215872
- Sponsor's protocol ID
- BAU-ALKAN-001
- Status last verified
- Jan 2024
- First submitted
- 29 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Structured Myofacial Chain Exercise Training Applied in the Early Period After Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT06215872
- Acronym / sponsor ID
- BAU-ALKAN-001
- Conditions
- Distal Radius Fractures
- Keywords
- Tele-Health, Exercise, Physical Therapy And Rehabilitation, Distal Radius Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Collaborators
- Atlas University
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 22 Jan 2024 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Prospective Randomized Control Single-Blind Study
| Arm | Type | Receives |
|---|---|---|
| Upper Extremity Exercises Group | Active comparator | Other: Therapeutic ExercisesParticipants will treated exercises with focused on upper extremity especially wrist muscles. |
| Myofascial Chains Exercises Group | Experimental | Other: Therapeutic ExercisesParticipants will treated exercises with focused on whole body especilly myofascial chains. |
| Control Group | No intervention | –Participants will do any exercises. They will join only assessment sessions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Therapeutic ExercisesParticipants 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. | Other | Myofascial Chains Exercises Group, Upper Extremity Exercises Group |
Primary outcome
Quick DASH (The Disabilities of the Arm, Shoulder and Hand)
Time frame: Pre treatment and end of study (4 weeks after from first assessment)
Quick-DASH is an 11-item questionnaire that questions a person's limitations in upper extremity problems.
7 secondary outcomes
The Visual Analogue Scale (VAS)
Time frame: Pre treatment and end of study (4 weeks after from first assessment)
Hand Functional Index (HFI)
Time frame: Pre treatment and end of study (4 weeks after from first assessment)
Michigan Hand Outcomes Questionnaire (MHQ)
Time frame: Pre treatment and end of study (4 weeks after from first assessment)
Joint Range of Motion Measurement Test With Goniometer
Time frame: Pre treatment and end of study (4 weeks after from first assessment)
Hand Grip Strength Measurement Test With Hand Dynamometer
Time frame: Pre treatment and end of study (4 weeks after from first assessment)
Pinch Grip Strength With Pinch Meter
Time frame: Pre treatment and end of study (4 weeks after from first assessment)
Fingertip Dexterity and Gross Movement of the Hand With The Purdue Pegboard Test (PPT)
Time frame: Pre treatment and end of study (4 weeks after from first assessment)
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 22 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Exercises in people with Distal Radius Fractures, run by Bahçeşehir University 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 9 inclusion and 6 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 22 Jan 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?
Quick DASH (The Disabilities of the Arm, Shoulder and Hand) (time frame: Pre treatment and end of study (4 weeks after from first assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2024.