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Recruiting NCT06913933

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

No phase Interventional Distal Radius Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Static Progressive Splinting for Persistent Wrist Stiffness, Dynamic Splinting for Persistent Wrist Stiffness.
Who it may be relevant to
Registry conditions: Distal Radius Fractures. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral 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.
  • Behavioral 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.

Primary outcome measures

  • Wrist Active and Passive Range of Motion (AROM/PROM) [Time frame: Assessed at baseline, 6 weeks (post-intervention), and 3 months follow-up.]
Secondary outcome measures (3)
  • Patient-Rated Wrist Evaluation (PRWE) [Time frame: Assessed at baseline and at 6 weeks post-intervention.]
  • Patient Satisfaction [Time frame: Collected at 6 weeks and 3 months post-intervention.]
  • Incidence of Adverse Events [Time frame: Continuously monitored from baseline to the 3-month follow-up.]

Eligibility criteria

Inclusion criteria

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 criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Physical Therapy, Al Hayah University — Cairo

Identifiers

NCT: NCT06913933 · SPDS2025-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗