Effects of Different Wrist Positions in Dorsal Blocking Orthoses After Flexor Tendon Repair

March 28, 2026 updated by: Sedanur Güngör

Effects of Different Wrist Positions in 3D-Printed Dorsal Blocking Orthoses on Clinical and Functional Outcomes After Zone I-II Flexor Tendon Repair: A Randomized Controlled Study

This randomized controlled study aims to compare the effects of three different wrist positions (30° extension, neutral, and 30° flexion) used in dorsal blocking orthoses during early active mobilization after zone I-II flexor tendon repair. A total of 54 patients will be randomly assigned into three groups. All participants will receive the same rehabilitation protocol. Clinical and functional outcomes including total active motion, pain, complications, functional status, and orthosis satisfaction will be evaluated at 6, 8, and 12 weeks by a blinded assessor.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals aged 16 years and older
  • Patients who underwent zone I or II flexor tendon repair using at least a four--strand suture technique
  • Referral to physiotherapy within the first 10 days after surgery
  • Eligibility for a controlled early active mobilization protocol
  • Ability to understand and complete Turkish assessment questionnaires
  • Adequate cognitive function (Montreal Cognitive Assessment score >21)
  • Voluntary participation with written informed consent

Exclusion Criteria:

  • Thumb tendon repairs
  • Multiple or complex injuries (e.g., concomitant peripheral nerve injury, fractures requiring immobilization, joint dislocation, extensor tendon injury)
  • Active infection
  • Severe edema preventing orthosis use
  • Dermatological conditions or allergies preventing orthosis application
  • Systemic diseases that may affect rehabilitation (e.g., diabetes mellitus, -peripheral neuropathy, stroke, advanced rheumatoid arthritis)
  • Pre-existing wrist pain or deformity prior to injury
  • Inability to attend follow-up assessments
  • Non-compliance with the home exercise program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wrist Extension Group
Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° extension and follow a controlled early active mobilization protocol.
Device: 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree extension)
Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° extension and follow a controlled early active mobilization protocol.
Other Names:
  • Early Active Mobilization Protocol
Experimental: Neutral Wrist Group
Participants will use a 3D-printed dorsal blocking orthosis with the wrist in neutral position and follow the same rehabilitation protocol.
Device: 3D-Printed Dorsal Blocking Orthosis (wrist neutral)
Participants will use a 3D-printed dorsal blocking orthosis with the wrist in neutral position and follow the same rehabilitation protocol.
Other Names:
  • Early Active Mobilization Protocol
Experimental: Wrist Flexion Group
Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° flexion and follow the same rehabilitation protocol.
Device: 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree flexion)
Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° flexion and follow the same rehabilitation protocol.
Other Names:
  • Early Active Mobilization Protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Active Motion (TAM)
Time Frame: 12 week
Total active motion will be calculated by summing the active flexion angles of the metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints and subtracting any extension deficits. Measurements will be performed using a finger goniometer and evaluated according to the Buck-Gramcko classification.
12 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: 6, 8, and 12 weeks
Pain intensity will be assessed using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).
6, 8, and 12 weeks
Hand Function
Time Frame: 6, 8 and 12 weeks
Hand function will be evaluated using the Jebsen-Taylor Hand Function Test, which measures the time required to complete standardized hand tasks.
6, 8 and 12 weeks
Upper Extremity Function
Time Frame: 6, 8, and 12 weeks
Upper extremity functional status will be assessed using the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire. Lower scores indicate better function.
6, 8, and 12 weeks
Grip Strength
Time Frame: 6, 8, and 12 weeks
Grip strength will be measured using a hydraulic hand dynamometer and recorded in kilograms.
6, 8, and 12 weeks
Pinch Strength
Time Frame: 6, 8, and 12 weeks
Pinch strength will be measured using a pinch meter and recorded in kilograms.
6, 8, and 12 weeks
Orthosis Satisfaction
Time Frame: 6 weeks
Patient satisfaction with the orthosis will be assessed using the Orthotics and Prosthetics Users' Survey (OPUS).
6 weeks
Complications
Time Frame: up to 12 weeks
Postoperative complications including tendon rupture, adhesions, edema, and skin irritation will be recorded during the follow-up period.
up to 12 weeks
Return to Daily Activities
Time Frame: Up to 12 weeks
Time to return to daily activities and work will be recorded in weeks.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sedanur Güngör

Collaborators

Gazi University Scientific Research Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

March 6, 2028

Study Completion (Estimated)

August 6, 2028

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 28, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025 - 2170

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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