Hand InjuriesNCT07668544
Kinesiophobia and Functional Outcomes in Hand Injuries
A study testing Standard Surgical Treatment and Routine Postoperative Care in people with Hand Injuries, run by Ebru Aloğlu Çiftçi.
Trial summary
Hand and forearm injuries are among the most common traumatic injuries and may result in substantial functional limitations, reduced work capacity, and decreased quality of life. Despite advances in surgical repair techniques, recovery outcomes vary considerably among individuals with similar injury characteristics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Injuries
- What is being tested?
- Standard Surgical Treatment and Routine Postoperative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 19 Jun 2026to 17 Mar 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older. Patients presenting to the emergency department with traumatic hand or forearm lacerations requiring surgical treatment.
- Injury involving one or more anatomical structures of the hand or forearm (skin, tendon, nerve, vessel, or combined injuries).
- Assessment within 1-5 days following injury. Ability to understand and complete study questionnaires and functional assessments.
- Provision of written informed consent. Willingness to participate in follow-up assessments at 8 and 12 weeks after injury.
Who cannot join
- Age younger than 18 years. Cognitive impairment, severe psychiatric disorder, or communication problems preventing completion of questionnaires.
- Previous major injury, surgery, or permanent functional impairment of the affected upper extremity.
- Polytrauma or additional injuries that may substantially affect upper extremity function or rehabilitation outcomes.
- Neurological disorders affecting upper extremity function (e.g., stroke, peripheral neuropathy, spinal cord injury).
- Severe musculoskeletal disorders of the upper extremity unrelated to the index injury.
- Inability or unwillingness to attend follow-up evaluations. Refusal to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Kinesiophobia Level on Functional Outcomes in Surgically Performed Hand Injuries
Hand and forearm injuries are among the most common traumatic injuries and may result in substantial functional limitations, reduced work capacity, and decreased quality of life. Despite advances in surgical repair techniques, recovery outcomes vary considerably among individuals with similar injury characteristics. Psychological factors, particularly fear of movement or reinjury (kinesiophobia), may influence rehabilitation participation and functional recovery after injury.
The aim of this prospective observational study is to investigate the relationship between early kinesiophobia levels and functional outcomes in adults who undergo surgical treatment for traumatic hand or forearm lacerations. Kinesiophobia will be assessed during the acute post-injury period (within 1-5 days after injury) using the Tampa Scale of Kinesiophobia. Injury severity will be evaluated using the Modified Hand Injury Severity Classification (MHISC/MEYCS).
Read more
Participants will be followed for 12 weeks after injury. Functional recovery will be assessed at the 8th week using the Buck-Gramcko Score and the Sollerman Hand Function Test, and at the 12th week using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and hand grip strength measurements.
The study will examine whether higher levels of early kinesiophobia are associated with greater injury severity and poorer functional recovery. Findings from this study may help identify patients at risk for delayed recovery and support the development of early rehabilitation strategies targeting psychological as well as physical aspects of hand injury recovery.
- Conditions
- Hand Injuries
- Being tested
- Standard Surgical Treatment and Routine Postoperative Care
- Keywords
- kinesiophobia, functionality
- Medical subject headings
- Hand Injuries, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Surgical Treatment and Routine Postoperative CareOther
Also called Routine Clinical Management
Participants with traumatic hand or forearm injuries will receive surgical treatment and postoperative management according to routine clinical practice and the treating surgeon's decision. No experimental treatment, device, medication, or rehabilitation protocol will be administered as part of the study. The study is observational in nature and aims to evaluate the relationship between early kinesiophobia levels, injury severity, and subsequent functional outcomes following standard surgical care.
| Study group | Role | What they receive |
|---|---|---|
| Minor Injury Group | Experimental | Participants with traumatic hand or forearm injuries classified as minor according to the Modified Hand Injury Severity Classification (MHISC/MEYCS) score (MEYCS <20). Patients will undergo standard surgical treatment and routine postoperative care and will be followed for assessment of kinesiophobia and functional outcomes. Receives: Other: Standard Surgical Treatment and Routine Postoperative Care |
| Moderate Injury Group | Experimental | Participants with traumatic hand or forearm injuries classified as moderate according to the Modified Hand Injury Severity Classification (MHISC/MEYCS) score (MEYCS 21-50). Patients will undergo standard surgical treatment and routine postoperative care and will be followed for assessment of kinesiophobia and functional outcomes. Receives: Other: Standard Surgical Treatment and Routine Postoperative Care |
| Severe Injury Group | Experimental | Participants with traumatic hand or forearm injuries classified as severe according to the Modified Hand Injury Severity Classification (MHISC/MEYCS) score (MEYCS 51-100). Patients will undergo standard surgical treatment and routine postoperative care and will be followed for assessment of kinesiophobia and functional outcomes. Receives: Other: Standard Surgical Treatment and Routine Postoperative Care |
| Major Injury Group | Experimental | Participants with traumatic hand or forearm injuries classified as major according to the Modified Hand Injury Severity Classification (MHISC/MEYCS) score (MEYCS >101). Patients will undergo standard surgical treatment and routine postoperative care and will be followed for assessment of kinesiophobia and functional outcomes. Receives: Other: Standard Surgical Treatment and Routine Postoperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Functional disability and symptoms of the upper extremity assessed using the Turkish version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The study will evaluate the association between early kinesiophobia levels measured within 1-5 days after injury and functional outcomes at 12 weeks following surgically treated hand and forearm injuries.
Measured: 12 weeks after injury
Secondary outcomes (5)
Hand Grip Strength
Grip strength of the injured hand measured using a standard hand dynamometer. Three measurements will be obtained and the mean value will be recorded.
Measured: 12 weeks after injury
Buck-Gramcko Functional Score
Hand function, pain, and range of motion assessed using the Buck-Gramcko scoring system to evaluate intermediate-term functional recovery.
Measured: 8 weeks after injury
Sollerman Hand Function Test Score
Hand function during activities of daily living assessed using the Sollerman Hand Function Test.
Measured: 8 weeks after injury
Tampa Scale of Kinesiophobia (TSK) Score
Fear of movement and reinjury assessed using the Turkish version of the Tampa Scale of Kinesiophobia during the acute post-injury period.
Measured: Within 1-5 days after injury
Modified Hand Injury Severity Classification (MHISC/MEYCS) Score
Injury severity assessed using the Modified Hand Injury Severity Classification (MEYCS) at the time of initial evaluation.
Measured: Within 1-5 days after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start19 Jun 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion17 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand InjuriesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ebru Aloğlu Çiftçi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ebru Aloğlu Çiftçi, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668544
- Sponsor's protocol ID
- MarmaraUni-01
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cantero-Tellez R, Rider J, Cruz-Gambero L, Villafane JH, Valdes K. Kinesiophobia, catastrophizing, and the duration of immobilization: A prospective study on factors associated with shoulder disability following wrist-hand injuries. J Hand Ther. 2025 Jul-Sep;38(3):477-482. doi: 10.1016/j.jht.2024.08.004. Epub 2025 Jan 6.
PubMed 39765429
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kinesiophobia Level on Functional Outcomes in Surgically Performed Hand Injuries
- ClinicalTrials.gov ID
- NCT07668544
- Acronym / sponsor ID
- MarmaraUni-01
- Conditions
- Hand Injuries
- Keywords
- kinesiophobia, functionality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ebru Aloğlu ÇiftçiUniversity, hospital or other
- Study start
- 19 Jun 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 17 Mar 2027 (estimated)
- First posted
- 25 Jun 2026 (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.
Hand and forearm injuries are among the most common traumatic injuries and may result in substantial functional limitations, reduced work capacity, and decreased quality of life. Despite advances in surgical repair techniques, recovery outcomes vary considerably among individuals with similar injury characteristics. Psychological factors, particularly fear of movement or reinjury (kinesiophobia), may influence rehabilitation participation and functional recovery after injury.
The aim of this prospective observational study is to investigate the relationship between early kinesiophobia levels and functional outcomes in adults who undergo surgical treatment for traumatic hand or forearm lacerations. Kinesiophobia will be assessed during the acute post-injury period (within 1-5 days after injury) using the Tampa Scale of Kinesiophobia. Injury severity will be evaluated using the Modified Hand Injury Severity Classification (MHISC/MEYCS).
Participants will be followed for 12 weeks after injury. Functional recovery will be assessed at the 8th week using the Buck-Gramcko Score and the Sollerman Hand Function Test, and at the 12th week using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and hand grip strength measurements.
The study will examine whether higher levels of early kinesiophobia are associated with greater injury severity and poorer functional recovery. Findings from this study may help identify patients at risk for delayed recovery and support the development of early rehabilitation strategies targeting psychological as well as physical aspects of hand injury recovery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Minor Injury Group | Experimental | Other: Standard Surgical Treatment and Routine Postoperative CareParticipants with traumatic hand or forearm injuries classified as minor according to the Modified Hand Injury Severity Classification (MHISC/MEYCS) score (MEYCS <20). Patients will undergo standard surgical treatment and routine postoperative care and will be followed for assessment of kinesiophobia and functional outcomes. |
| Moderate Injury Group | Experimental | Other: Standard Surgical Treatment and Routine Postoperative CareParticipants with traumatic hand or forearm injuries classified as moderate according to the Modified Hand Injury Severity Classification (MHISC/MEYCS) score (MEYCS 21-50). Patients will undergo standard surgical treatment and routine postoperative care and will be followed for assessment of kinesiophobia and functional outcomes. |
| Severe Injury Group | Experimental | Other: Standard Surgical Treatment and Routine Postoperative CareParticipants with traumatic hand or forearm injuries classified as severe according to the Modified Hand Injury Severity Classification (MHISC/MEYCS) score (MEYCS 51-100). Patients will undergo standard surgical treatment and routine postoperative care and will be followed for assessment of kinesiophobia and functional outcomes. |
| Major Injury Group | Experimental | Other: Standard Surgical Treatment and Routine Postoperative CareParticipants with traumatic hand or forearm injuries classified as major according to the Modified Hand Injury Severity Classification (MHISC/MEYCS) score (MEYCS >101). Patients will undergo standard surgical treatment and routine postoperative care and will be followed for assessment of kinesiophobia and functional outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years and older. Patients presenting to the emergency department with traumatic hand or forearm lacerations requiring surgical treatment.
- Injury involving one or more anatomical structures of the hand or forearm (skin, tendon, nerve, vessel, or combined injuries).
- Assessment within 1-5 days following injury. Ability to understand and complete study questionnaires and functional assessments.
- Provision of written informed consent. Willingness to participate in follow-up assessments at 8 and 12 weeks after injury.
Key exclusion criteria (6 listed)
- Age younger than 18 years. Cognitive impairment, severe psychiatric disorder, or communication problems preventing completion of questionnaires.
- Previous major injury, surgery, or permanent functional impairment of the affected upper extremity.
- Polytrauma or additional injuries that may substantially affect upper extremity function or rehabilitation outcomes.
- Neurological disorders affecting upper extremity function (e.g., stroke, peripheral neuropathy, spinal cord injury).
- Severe musculoskeletal disorders of the upper extremity unrelated to the index injury.
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 |
|---|---|---|
| Standard Surgical Treatment and Routine Postoperative CareAlso: Routine Clinical ManagementParticipants with traumatic hand or forearm injuries will receive surgical treatment and postoperative management according to routine clinical practice and the treating surgeon's decision. No experimental treatment, device, medication, or rehabilitation protocol will be administered as part of the study. The study is observational in nature and aims to evaluate the relationship between early kinesiophobia levels, injury severity, and subsequent functional outcomes following standard surgical care. | Other | Major Injury Group, Minor Injury Group, Moderate Injury Group, Severe Injury Group |
Primary outcome
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time frame: 12 weeks after injury
Functional disability and symptoms of the upper extremity assessed using the Turkish version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The study will evaluate the association between early kinesiophobia levels measured within 1-5 days after injury and functional outcomes at 12 weeks following surgically treated hand and forearm injuries.
5 secondary outcomes
Hand Grip Strength
Time frame: 12 weeks after injury
Buck-Gramcko Functional Score
Time frame: 8 weeks after injury
Sollerman Hand Function Test Score
Time frame: 8 weeks after injury
Tampa Scale of Kinesiophobia (TSK) Score
Time frame: Within 1-5 days after injury
Modified Hand Injury Severity Classification (MHISC/MEYCS) Score
Time frame: Within 1-5 days after injury
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 25 Jun 2026.
- Background: PubMed 39765429Cantero-Tellez R, Rider J, Cruz-Gambero L, Villafane JH, Valdes K. Kinesiophobia, catastrophizing, and the duration of immobilization: A prospective study on factors associated with shoulder disability following wrist-hand injuries. J Hand Ther. 2025 Jul-Sep;38(3):477-482. doi: 10.1016/j.jht.2024.08.004. Epub 2025 Jan 6.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Surgical Treatment and Routine Postoperative Care in people with Hand Injuries, run by Ebru Aloğlu Çiftçi.
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 4 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: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Samir İlgaroğlu, Surgeon (+905536166156, doktorsamir.zeynal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder and Hand (DASH) Score (time frame: 12 weeks after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07668544, which also lists 1 linked publication.
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 25 Jun 2026.