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

NCT07489235 | Not Yet Recruiting

• 1 other identifier: 2025 - 2170
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Flexor Tendon Injury; Tendon Injury - Hand

Keywords

flexor tendon; orthosis; splint; 3D printing; therapy; rehabilitation; immobilization

Outcome Measures

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.

  12 week

Secondary Outcomes (8)

• Pain Intensity

  6, 8, and 12 weeks

• Hand Function

  6, 8 and 12 weeks

• Upper Extremity Function

  6, 8, and 12 weeks

• Grip Strength

  6, 8, and 12 weeks

• Pinch Strength

  6, 8, and 12 weeks

Study Arms (3)

Wrist Extension Group

EXPERIMENTAL

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)

Neutral Wrist Group

EXPERIMENTAL

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)

Wrist Flexion Group

EXPERIMENTAL

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)

Interventions

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.

Also known as: Early Active Mobilization Protocol

Wrist Extension Group

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.

Also known as: Early Active Mobilization Protocol

Neutral Wrist Group

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.

Also known as: Early Active Mobilization Protocol

Wrist Flexion Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sedanur Güngör: lead
• Gazi University Scientific Research Unit: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Model Description

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 24, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): March 6, 2028
• Study Completion (Estimated): August 6, 2028
• Last Updated: April 2, 2026

Record last verified: 2025-12