RecruitingNot ApplicableNCT06913933

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

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


Sponsor

Al Hayah University In Cairo

Enrollment

50 participants

Start Date

Apr 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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

Exclusion Criteria4

  • 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.

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Interventions

BEHAVIORALStatic 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.

BEHAVIORALDynamic 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.


Locations(1)

Faculty of Physical Therapy, Al Hayah University

Cairo, Egypt

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NCT06913933


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