NCT07388303

Brief Summary

Patient-reported outcome measures, which are subjective by nature, need to be correlated with clinician-administered professional measurements as a further step toward expanding their clinical utility. Therefore, this study aimed to investigate the relationship between perceived manual dexterity and functional measurements in patients with hand-forearm injuries.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2025May 2026

Study Start

First participant enrolled

January 6, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

January 28, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

hand forearm injuriesperceived manual abilityfunctional measurements

Outcome Measures

Primary Outcomes (5)

  • The Modified Hand Injury Severity Score

    It is a four-component scoring system developed to determine the severity of hand and forearm injuries: integumentary (skin and nail), skeletal (bone and ligament), motor (tendon), and neurovascular (nerve and vascular). The total score is obtained by summing the scores of all components and is classified into four categories: minor (\<20), moderate (21-50), severe (51-100), and major (\>101) injury.

    At baseline

  • Manual Ability Measure-36

    It is a self-report questionnaire specifically developed to measure hand dexterity. It is an outcome measure that reflects patients' perceived functional hand use or their ability to perform activities of daily living. Higher scores indicate higher levels of function.

    At the 6th and 12th weeks following injury or surgery

  • The Jebsen-Taylor Hand Function Test

    It consists of seven subtests: writing, turning over cards, picking up small common objects, simulated feeding, stacking checkers, moving light objects, and moving heavy objects.

    At the 6th and 12th weeks following injury or surgery

  • The Nine-Hole Peg Test

    It is a simple, rapid, and manual dexterity test with proven validity and reliability. It is particularly sensitive to changes in upper extremity performance.

    At the 6th and 12th weeks following injury or surgery

  • Gross and fine grip strength

    These measurements are performed according to the procedure recommended by the American Society of Hand Therapists.

    At the 6th and 12th weeks following injury or surgery

Study Arms (1)

Patients treated conservatively or surgically in the orthopedics clinic due to hand-forearm injuries

Other: Questionnaire and Physical Exam

Interventions

The Modified Hand Injury Severity Score is used to determine the severity level of patients' injuries. At the 6th and 12th weeks following the injury or surgery, patients are administered the Manual Ability Measure-36 questionnaire, and the Jebsen-Taylor Hand Function Test and Nine-Hole Peg Test are performed. Additionally, the grip strength of the subjects is evaluated at the 12th week.

Patients treated conservatively or surgically in the orthopedics clinic due to hand-forearm injuries

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated conservatively or surgically in the orthopedics clinic due to hand-forearm injuries

You may qualify if:

  • Having sustained a hand and/or forearm injury and/or having undergone surgery related to this injury.
  • Being voluntary to participate in the study.

You may not qualify if:

  • Patients with concomitant central nervous system involvement.
  • Patients with a history of previous injury to the same extremity.
  • Patients with rheumatological disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20170, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Rallon, C. R., & Chen, C. C. (2008). Relationship between performance-based and self-reported assessment of hand function. American Journal of Occupational Therapy, 62(5), 574-579.

    BACKGROUND
  • Chen, C. C., & Bode, R. K. (2010). Psychometric validation of the Manual Ability Measure-36 (MAM-36) in patients with neurologic and musculoskeletal disorders. Archives of physical medicine and rehabilitation, 91(3), 414-420.

    BACKGROUND

MeSH Terms

Conditions

Hand InjuriesForearm Injuries

Interventions

Surveys and QuestionnairesRestraint, Physical

Condition Hierarchy (Ancestors)

Wounds and InjuriesArm Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilization

Study Officials

  • Umut Eraslan

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 5, 2026

Study Start

January 6, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations