NCT07134452

Brief 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 \[3\]. 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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

June 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

August 11, 2025

Last Update Submit

August 14, 2025

Conditions

Keywords

Scapholunate InstabilityIsokinetic Muscle StrengthWeight BearingProprioceptive SensationReaction TimeFunctionality

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    Baseline

  • Grip Strength Evaluation

    It will be evaluated with the JAMAR hand held dynamometer

    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.

    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.

    Baseline

  • Pain Evaluation

    It contains 10 cm line that should be assigned according to perceived pain intensity at rest, during activity and while exercising.

    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.

    Baseline

Secondary Outcomes (1)

  • PRWHE (Patient-Rated Wrist/Hand Evaluation)

    Baseline

Study Arms (2)

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.

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.

Diagnostic Test: Baseline Assessments

Interventions

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

Healty ControlsScapholunate Instability Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Being between the ages of 18-45
  • Applying to the clinic within the last 6 months
  • Being diagnosed with dynamic scapholunate instability

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Yeni Yuzyil University

Istanbul, Cevizlibag / Zeytinburnu, 34010, Turkey (Türkiye)

Location

Study Officials

  • Arzu Dağ

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctorate student

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 21, 2025

Study Start

June 1, 2025

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

August 21, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations