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| Name | Class |
|---|---|
| Gazi University Scientific Research Unit | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | 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 | Hand function will be evaluated using the Jebsen-Taylor Hand Function Test, which measures the time required to complete standardized hand tasks. |
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Inclusion Criteria:
Exclusion Criteria:
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Model Description
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Masking Description
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| 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. |
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| 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. |
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| 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. | 6, 8, and 12 weeks |
| Grip Strength | Grip strength will be measured using a hydraulic hand dynamometer and recorded in kilograms. | 6, 8, and 12 weeks |
| Pinch Strength | Pinch strength will be measured using a pinch meter and recorded in kilograms. | 6, 8, and 12 weeks |
| Orthosis Satisfaction | Patient satisfaction with the orthosis will be assessed using the Orthotics and Prosthetics Users' Survey (OPUS). | 6 weeks |
| Complications | 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 to return to daily activities and work will be recorded in weeks. | Up to 12 weeks |