Scapholunate Interosseous Ligament InjuryNCT07134452
Comparison of Strength, Weight Bearing, Proprioception, Reaction Time and Function in Scapholunate Instability
An observational study of Scapholunate Interosseous Ligament Injury and Scaphoid-Lunate Instability, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Scapholunate (SL) instability is the most common type of instability seen in the wrist, resulting from SLI injury or excessive mobility [1,2]. It usually occurs after trauma and can range from mild injury to severe malalignment [3]. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Scapholunate Interosseous Ligament Injury, Scaphoid-Lunate Instability, Scapholunate Dissociation
- What is being tested?
- Baseline Assessments
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults aged 18-45 years. The case group will include individuals diagnosed with scapholunate instability confirmed by clinical and radiological examination. The control group will consist of age- and sex-matched healthy individuals with no history of wrist injury or upper extremity musculoskeletal disorders.
Who may be able to join
- Being between the ages of 18-45
- Applying to the clinic within the last 6 months
- Being diagnosed with dynamic scapholunate instability
Who cannot join
- Having a history of previous hand or wrist surgery,
- Having a history of Reflex Sympathetic Dystrophy,
- Having a Scapholunate Advanced Collapse lesion,
- Having a serious systemic neurological, or psychiatric illness,
- Having been undergoing upper extremity rehabilitation in the last six months, did not wish to participate in the study, or were unable to follow the protocols.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Yeni Yuzyil University
Istanbul, Cevizlibag / Zeytinburnu, 34010
About this study
Official title: Comparison of Isokinetic Muscle Strength, Grip Strength, Weight Bearing, Proprioceptive Sense, Reaction Time and Functional Parameters Between Subjects With Scapholunate Instability and Healthy Individuals: A Cross-sectional Study
Scapholunate (SL) instability is the most common type of instability seen in the wrist, resulting from SLI injury or excessive mobility [1,2]. It usually occurs after trauma and can range from mild injury to severe malalignment [3]. Symptoms include dorsal pain, clicking sound, limited movement, increased pain with weight-bearing, and weakness [4,5]. Pain reduces joint movement and grip strength, limiting daily activities [6]. If there is no dislocation, conservative treatment (education, exercise, splinting) is applied [7].
The wrist absorbs and transfers load through ligaments. During flexion-extension, the scaphoid and lunate follow the capitate [10]. SLIL injuries alter forearm muscle activation. EKRL, EKRB, APL, and FKR are "scapholunate-friendly" muscles; EKU is not recommended due to its pronator effect [12-15]. SLIL mechanoreceptors enhance dynamic stability [11,19]. There are no studies objectively measuring the strength of these muscles.
Read more
Isokinetic muscle assessment has not been performed in SL instability. These measurements objectively determine muscle strength and imbalances, personalizing treatment. Weight transfer capacity, reaction time, and proprioception have also not been studied. However, weight transfer is an indicator of stability, proprioception is critical for functionality, and reaction time reflects neuromuscular response speed [23-27].
The aim of this study is to compare forearm isokinetic muscle strength, grip strength, weight transfer, proprioception, reaction time, and functionality in individuals with SL instability with those in healthy individuals.
Read the detailed description
Scapholunate (SL) instability is the most common type of instability in the wrist, resulting from injury or excessive mobility of the scapholunate interosseous ligaments (SLIL) [1,2]. This condition, which typically arises following trauma, can range in severity from partial ligament injury to irreparable ligament damage and malalignment [3]. Symptoms include dorsal pain, clicking sounds, limited range of motion, a sensation of catching, pain exacerbated by loading, and weakness [4,5]. Pain that occurs during weight-bearing can reduce joint range of motion and grip strength, thereby limiting daily living activities [6]. In cases without radiological findings of dislocation, conservative treatment (education, exercise, splinting) is preferred [7].
The wrist facilitates load absorption and transfer through complex mechanisms and ligaments. During flexion and extension, the scaphoid and lunate follow the movement of the capitate [10]. In SLI injuries, impaired ligament-muscular reflexes alter the activation patterns of the forearm muscles. Among these muscles, the extensor carpi radialis longus (ECRL), extensor carpi radialis brevis (ECRB), abductor pollicis longus (APL), and flexor carpi radialis (FCR) are defined as scapholunate-friendly; the extensor carpi ulnaris (ECU) has been reported as a muscle to be avoided due to its intracarpal pronator effect [12-15].
In recent years, it has been emphasized that static stability approaches are insufficient and that neuromuscular control has gained importance [2]. It has been shown that the SLIL and wrist ligaments are rich in mechanoreceptors and that these structures increase dynamic stability by activating the forearm muscles [11,19]. However, there are no studies that objectively measure the strength of the scapholunate-friendly muscles.
There is no information in the literature regarding the evaluation of wrist muscles in SL instability using an isokinetic system. Isokinetic measurements are also extremely limited in other pathologies affecting the wrist [20-22]. Isokinetic devices measure muscle strength at a constant speed, objectively determining performance at different speeds and revealing muscle imbalances. This enables treatment plans to be personalized.
Similarly, there are no studies examining parameters such as weight transfer capacity, reaction time, and proprioception in SL instability. However, upper extremity load transfer is an important indicator of stability [23-25], and proprioception is critical for functionality. Reaction time indicates the neuromuscular system's ability to respond quickly, and it is thought that this mechanism may be affected in instability [26,27].
This study aims to investigate forearm isokinetic muscle strength, grip strength, weight transfer capacity, proprioceptive sensation, reaction time, and functionality in individuals with scapholunate instability compared to healthy individuals.
Hypotheses H1: Isokinetic forearm muscle strength in patients with SL instability differs from that in healthy individuals.
H2: Grip strength differs between patients with SL instability and healthy individuals.
H3: Proprioceptive sensation differs between patients with SL instability and healthy individuals.
H4: Reaction time differs between patients with SL instability and healthy individuals.
H5: Weight transfer onto the hand differs between patients with SL instability and healthy individuals.
H6: Upper extremity functionality differs between patients with SL instability and healthy individuals.
- Conditions
- Scapholunate Interosseous Ligament Injury, Scaphoid-Lunate Instability, Scapholunate Dissociation
- Being tested
- Baseline Assessments
- Keywords
- Scapholunate Instability, Isokinetic Muscle Strength, Weight Bearing, Proprioceptive Sensation, Reaction Time, Functionality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline AssessmentsDiagnostic test
Evaluation of isokinetic muscle strength, grip strength, upper extremity weight-bearing capacity, proprioceptive sense, reaction time, and functional performance in both groups
| Study group | Role | What they receive |
|---|---|---|
| Scapholunate Instability Group | Individuals diagnosed with scapholunate interosseous ligament injury confirmed by clinical and radiological assessment. Participants will undergo baseline evaluations including isokinetic muscle strength, grip strength, weight-bearing capacity, proprioception, reaction time, and functional assessments. Receives: Diagnostic Test: Baseline Assessments | |
| Healty Controls | Age- and sex-matched healthy individuals with no history of wrist injury or upper extremity musculoskeletal disorders. Participants will undergo the same baseline evaluations as the scapholunate instability group. Receives: Diagnostic Test: Baseline Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic Muscle Strength Evaluation
It will be evaluated with the Isokinetic Cybex device. At 60/90/ angular velocities, the extensor-flexor peak torque force / work produced by the muscle will be evaluated concentrically.
Measured: Baseline
Weight-Bearing Test
Test protocol: The subject will be asked to apply as much pressure as possible with the extended elbow and wrist on a digital scale. The subjects will perform 3 trials and the average value will be recorded in kilograms and will be compared with the weight transfer test of the unaffected hand, which is determined as a normative value for maximum weight-bearing capacity.
Measured: Baseline
Grip Strength Evaluation
It will be evaluated with the JAMAR hand held dynamometer
Measured: Baseline
Wrist Proprioception Evaluation
t will be evaluated with the Isokinetic Cybex Device device The hand will be brought to the target angle value of 30 degrees extension or 30 degrees flexion with the help of a physiotherapist and will be waited for approximately 5 seconds. After the patient learns, he/she will be asked to do it himself/herself with his/her eyes closed. After the movement is repeated 3 times in a row, the participant will be asked to actively apply the determined target extension movement to the same extremity. The difference between the target angle and the measured angle.The difference between the target angle and the measured angle will be recorded as the margin of error.
Measured: Baseline
Reaction Time Evaluation
Upper extremity reaction time evaluation will be performed with the reaction speed measurement and exercise set Blazepod Trainer (Blazepod Trainer Device, Play Coyotta Ltd. Tel Aviv Israel) device. Individuals will be asked to turn off the 5 LEDs placed on the table in front of them as quickly as possible with one hand in the sitting position. Both hands will be evaluated. The number of LEDs extinguished in 30 seconds (number), the unit extinguishing time (msec) and the number of LEDs missed when the LEDs extinguished after a 5-second waiting period will be recorded. Measurements will be made on both hands.
Measured: Baseline
Pain Evaluation
It contains 10 cm line that should be assigned according to perceived pain intensity at rest, during activity and while exercising.
Measured: Baseline
Quick DASH
The QuickDASH is a subset of 11 items from the 30-item DASH and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
Measured: Baseline
Secondary outcomes (1)
PRWHE (Patient-Rated Wrist/Hand Evaluation)
Patient-Rated Wrist/Hand Evaluation (PRWHE) is a self-reported questionnaire designed to assess wrist and hand pain and functional status. It consists of 15 items, including 5 pain-related questions and 10 function-related questions. Each item is scored on a 0-10 scale, with higher scores indicating greater pain or disability. The total score ranges from 0 (best) to 100 (worst).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Jun 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scapholunate Interosseous Ligament InjuryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- İstanbul Yeni Yüzyıl Üniversitesi
- Responsible party
- Principal investigator, Arzu Dağ, Hacettepe University
- Investigators
- Arzu Dağ, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134452
- Sponsor's protocol ID
- 2025/659
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 21 Aug 2025
- 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 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Isokinetic Muscle Strength, Grip Strength, Weight Bearing, Proprioceptive Sense, Reaction Time and Functional Parameters Between Subjects With Scapholunate Instability and Healthy Individuals: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07134452
- Acronym / sponsor ID
- 2025/659
- Conditions
- Scapholunate Interosseous Ligament Injury, Scaphoid-Lunate Instability, Scapholunate Dissociation
- Keywords
- Scapholunate Instability, Isokinetic Muscle Strength, Weight Bearing, Proprioceptive Sensation, Reaction Time, Functionality
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- İstanbul Yeni Yüzyıl Üniversitesi
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 21 Aug 2025 (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.
Scapholunate (SL) instability is the most common type of instability seen in the wrist, resulting from SLI injury or excessive mobility [1,2]. It usually occurs after trauma and can range from mild injury to severe malalignment [3]. Symptoms include dorsal pain, clicking sound, limited movement, increased pain with weight-bearing, and weakness [4,5]. Pain reduces joint movement and grip strength, limiting daily activities [6]. If there is no dislocation, conservative treatment (education, exercise, splinting) is applied [7].
The wrist absorbs and transfers load through ligaments. During flexion-extension, the scaphoid and lunate follow the capitate [10]. SLIL injuries alter forearm muscle activation. EKRL, EKRB, APL, and FKR are "scapholunate-friendly" muscles; EKU is not recommended due to its pronator effect [12-15]. SLIL mechanoreceptors enhance dynamic stability [11,19]. There are no studies objectively measuring the strength of these muscles.
Isokinetic muscle assessment has not been performed in SL instability. These measurements objectively determine muscle strength and imbalances, personalizing treatment. Weight transfer capacity, reaction time, and proprioception have also not been studied. However, weight transfer is an indicator of stability, proprioception is critical for functionality, and reaction time reflects neuromuscular response speed [23-27].
The aim of this study is to compare forearm isokinetic muscle strength, grip strength, weight transfer, proprioception, reaction time, and functionality in individuals with SL instability with those in healthy individuals.
Detailed description
Scapholunate (SL) instability is the most common type of instability in the wrist, resulting from injury or excessive mobility of the scapholunate interosseous ligaments (SLIL) [1,2]. This condition, which typically arises following trauma, can range in severity from partial ligament injury to irreparable ligament damage and malalignment [3]. Symptoms include dorsal pain, clicking sounds, limited range of motion, a sensation of catching, pain exacerbated by loading, and weakness [4,5]. Pain that occurs during weight-bearing can reduce joint range of motion and grip strength, thereby limiting daily living activities [6]. In cases without radiological findings of dislocation, conservative treatment (education, exercise, splinting) is preferred [7].
The wrist facilitates load absorption and transfer through complex mechanisms and ligaments. During flexion and extension, the scaphoid and lunate follow the movement of the capitate [10]. In SLI injuries, impaired ligament-muscular reflexes alter the activation patterns of the forearm muscles. Among these muscles, the extensor carpi radialis longus (ECRL), extensor carpi radialis brevis (ECRB), abductor pollicis longus (APL), and flexor carpi radialis (FCR) are defined as scapholunate-friendly; the extensor carpi ulnaris (ECU) has been reported as a muscle to be avoided due to its intracarpal pronator effect [12-15].
In recent years, it has been emphasized that static stability approaches are insufficient and that neuromuscular control has gained importance [2]. It has been shown that the SLIL and wrist ligaments are rich in mechanoreceptors and that these structures increase dynamic stability by activating the forearm muscles [11,19]. However, there are no studies that objectively measure the strength of the scapholunate-friendly muscles.
There is no information in the literature regarding the evaluation of wrist muscles in SL instability using an isokinetic system. Isokinetic measurements are also extremely limited in other pathologies affecting the wrist [20-22]. Isokinetic devices measure muscle strength at a constant speed, objectively determining performance at different speeds and revealing muscle imbalances. This enables treatment plans to be personalized.
Similarly, there are no studies examining parameters such as weight transfer capacity, reaction time, and proprioception in SL instability. However, upper extremity load transfer is an important indicator of stability [23-25], and proprioception is critical for functionality. Reaction time indicates the neuromuscular system's ability to respond quickly, and it is thought that this mechanism may be affected in instability [26,27].
This study aims to investigate forearm isokinetic muscle strength, grip strength, weight transfer capacity, proprioceptive sensation, reaction time, and functionality in individuals with scapholunate instability compared to healthy individuals.
Hypotheses H1: Isokinetic forearm muscle strength in patients with SL instability differs from that in healthy individuals.
H2: Grip strength differs between patients with SL instability and healthy individuals.
H3: Proprioceptive sensation differs between patients with SL instability and healthy individuals.
H4: Reaction time differs between patients with SL instability and healthy individuals.
H5: Weight transfer onto the hand differs between patients with SL instability and healthy individuals.
H6: Upper extremity functionality differs between patients with SL instability and healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scapholunate Instability Group | – | Diagnostic Test: Baseline AssessmentsIndividuals diagnosed with scapholunate interosseous ligament injury confirmed by clinical and radiological assessment. Participants will undergo baseline evaluations including isokinetic muscle strength, grip strength, weight-bearing capacity, proprioception, reaction time, and functional assessments. |
| Healty Controls | – | Diagnostic Test: Baseline AssessmentsAge- and sex-matched healthy individuals with no history of wrist injury or upper extremity musculoskeletal disorders. Participants will undergo the same baseline evaluations as the scapholunate instability group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults aged 18-45 years. The case group will include individuals diagnosed with scapholunate instability confirmed by clinical and radiological examination. The control group will consist of age- and sex-matched healthy individuals with no history of wrist injury or upper extremity musculoskeletal disorders.
Key inclusion criteria (3 listed)
- Being between the ages of 18-45
- Applying to the clinic within the last 6 months
- Being diagnosed with dynamic scapholunate instability
Key exclusion criteria (5 listed)
- Having a history of previous hand or wrist surgery,
- Having a history of Reflex Sympathetic Dystrophy,
- Having a Scapholunate Advanced Collapse lesion,
- Having a serious systemic neurological, or psychiatric illness,
- Having been undergoing upper extremity rehabilitation in the last six months, did not wish to participate in the study, or were unable to follow the protocols.
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 |
|---|---|---|
| Baseline AssessmentsEvaluation of isokinetic muscle strength, grip strength, upper extremity weight-bearing capacity, proprioceptive sense, reaction time, and functional performance in both groups | Diagnostic test | Healty Controls, Scapholunate Instability Group |
Primary outcome
Isokinetic Muscle Strength Evaluation
Time frame: Baseline
It will be evaluated with the Isokinetic Cybex device. At 60/90/ angular velocities, the extensor-flexor peak torque force / work produced by the muscle will be evaluated concentrically.
Weight-Bearing Test
Time frame: Baseline
Test protocol: The subject will be asked to apply as much pressure as possible with the extended elbow and wrist on a digital scale. The subjects will perform 3 trials and the average value will be recorded in kilograms and will be compared with the weight transfer test of the unaffected hand, which is determined as a normative value for maximum weight-bearing capacity.
Grip Strength Evaluation
Time frame: Baseline
It will be evaluated with the JAMAR hand held dynamometer
Wrist Proprioception Evaluation
Time frame: Baseline
t will be evaluated with the Isokinetic Cybex Device device The hand will be brought to the target angle value of 30 degrees extension or 30 degrees flexion with the help of a physiotherapist and will be waited for approximately 5 seconds. After the patient learns, he/she will be asked to do it himself/herself with his/her eyes closed. After the movement is repeated 3 times in a row, the participant will be asked to actively apply the determined target extension movement to the same extremity. The difference between the target angle and the measured angle.The difference between the target angle and the measured angle will be recorded as the margin of error.
Reaction Time Evaluation
Time frame: Baseline
Upper extremity reaction time evaluation will be performed with the reaction speed measurement and exercise set Blazepod Trainer (Blazepod Trainer Device, Play Coyotta Ltd. Tel Aviv Israel) device. Individuals will be asked to turn off the 5 LEDs placed on the table in front of them as quickly as possible with one hand in the sitting position. Both hands will be evaluated. The number of LEDs extinguished in 30 seconds (number), the unit extinguishing time (msec) and the number of LEDs missed when the LEDs extinguished after a 5-second waiting period will be recorded. Measurements will be made on both hands.
Pain Evaluation
Time frame: Baseline
It contains 10 cm line that should be assigned according to perceived pain intensity at rest, during activity and while exercising.
Quick DASH
Time frame: Baseline
The QuickDASH is a subset of 11 items from the 30-item DASH and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
1 secondary outcome
PRWHE (Patient-Rated Wrist/Hand Evaluation)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: No
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.
Arzu Dağ principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scapholunate Interosseous Ligament Injury and Scaphoid-Lunate Instability, run by Hacettepe 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Isokinetic Muscle Strength Evaluation (time frame: Baseline). The study lists 7 primary outcomes in all. 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 21 Aug 2025.