Health TrialsbyHealthPanel

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

ConditionsFlexor Tendon InjuryTendon Injury - Hand
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorSedanur Güngör

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree extension)

    Device

    Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° extension and follow a controlled early active mobilization protocol.

  • 3D-Printed Dorsal Blocking Orthosis (wrist neutral)

    Device

    Participants will use a 3D-printed dorsal blocking orthosis with the wrist in neutral position and follow the same rehabilitation protocol.

  • 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree flexion)

    Device

    Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° flexion and follow the same rehabilitation protocol.

Treatment groups

64 Participants
are divided into 3 treatment groups
Group A: Wrist Extension GroupExperimental treatment 1 intervention
Group B: Neutral Wrist GroupExperimental treatment 1 intervention
Group C: Wrist Flexion GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total Active Motion (TAM)

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.

Time frame
12 week

Secondary outcomes

1

Pain Intensity

Pain intensity will be assessed using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).

Time frame
6, 8, and 12 weeks
2

Hand Function

Hand function will be evaluated using the Jebsen-Taylor Hand Function Test, which measures the time required to complete standardized hand tasks.

Time frame
6, 8 and 12 weeks
3

Upper Extremity Function

Upper extremity functional status will be assessed using the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire. Lower scores indicate better function.

Time frame
6, 8, and 12 weeks
4

Grip Strength

Grip strength will be measured using a hydraulic hand dynamometer and recorded in kilograms.

Time frame
6, 8, and 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sedanur Güngör

Lead sponsor

Gazi University

Sponsor institution

Gazi University

Collaborator

Source ClinicalTrials.gov
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