Static vs. Dynamic Progressive Splinting for Persistent Wrist Stiffness After DRF

Официальное название

A Two-Arm, Parallel-Group Randomized Controlled Trial Comparing Static Progressive Splinting Versus Dynamic Splinting for Improving Wrist PROM/AROM in Patients With Persistent Post-DRF Stiffness

Обзор

This randomized controlled trial will compare the effectiveness of static progressive splinting versus dynamic splinting for treating persistent wrist stiffness in adults ≥18 years old at least 8 weeks post distal radius fracture (DRF) injury. Both splinting modalities are provided as an adjunct to one weekly supervised therapy session over a 6-week period. The primary outcomes are wrist active and passive range of motion (AROM/PROM) measured using goniometry, with secondary outcomes including patient-reported wrist function (PRWE), overall satisfaction, and adverse events.

Вмешательства

• Поведенческое Static Progressive Splinting for Persistent Wrist Stiffness
  A commercially available static progressive splint with a turnbuckle mechanism allowing fine-tuned adjustments in wrist flexion and extension. Instructional materials for home use including written guidelines and an adjustment log.
• Поведенческое Dynamic Splinting for Persistent Wrist Stiffness
  Materials: A commercially available dynamic (spring-loaded) splint designed for the wrist. An instructional manual and daily usage log for participants.

Первичные конечные точки

• Wrist Active and Passive Range of Motion (AROM/PROM) [Срок оценки: Assessed at baseline, 6 weeks (post-intervention), and 3 months follow-up.]

Вторичные конечные точки (3)

• Patient-Rated Wrist Evaluation (PRWE) [Срок оценки: Assessed at baseline and at 6 weeks post-intervention.]
• Patient Satisfaction [Срок оценки: Collected at 6 weeks and 3 months post-intervention.]
• Incidence of Adverse Events [Срок оценки: Continuously monitored from baseline to the 3-month follow-up.]

Критерии участия

Критерии включения

Adults aged 18 years or older. At least 8 weeks post distal radius fracture (operative or nonoperative) who have completed standard rehabilitation.

Demonstrated persistent wrist stiffness with ≤50% of contralateral wrist extension or flexion.

Capable of providing written informed consent and complying with study procedures

Критерии исключения

Presence of complex regional pain syndrome (CRPS) or active fracture healing issues.

History of significant wrist pathology unrelated to the DRF. Uncontrolled medical conditions that would interfere with splint application or therapy.

Known skin conditions or allergies that preclude orthosis use. Inability or unwillingness to adhere to the intervention protocol or follow-up schedule.

Pregnant or breastfeeding individuals.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Physical Therapy, Al Hayah University — Cairo

Идентификаторы

NCT: NCT06913933 · SPDS2025-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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