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

N/ANot Yet RecruitingNCT07489235

Sedanur Güngör64 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Flexor Tendon Injury Tendon Injury - Hand

Interventions

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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

Grip Strength

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

Time frame: 6, 8, and 12 weeks

Pinch Strength

Pinch strength will be measured using a pinch meter and recorded in kilograms.

Time frame: 6, 8, and 12 weeks

Orthosis Satisfaction

Patient satisfaction with the orthosis will be assessed using the Orthotics and Prosthetics Users' Survey (OPUS).

Time frame: 6 weeks

Complications

Postoperative complications including tendon rupture, adhesions, edema, and skin irritation will be recorded during the follow-up period.

Time frame: up to 12 weeks

Return to Daily Activities

Time to return to daily activities and work will be recorded in weeks.

Time frame: Up to 12 weeks