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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Wrist Active and Passive Range of Motion (AROM/PROM)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Dynamic Splinting Group (DSG)
Participants in this group receive dynamic splinting using a commercial device equipped with elastic tension (spring-loaded) that provides a constant dynamic stretch to the wrist. This intervention is delivered alongside a weekly supervised therapy session.
Intervention: Dynamic Splinting for Persistent Wrist Stiffness (Behavioral)
Static Progressive Splinting Group (SPSG)
Participants in this group receive static progressive splinting using a commercial splint that allows incremental adjustment through a turnbuckle design. This splint is used to gradually increase wrist extension and/or flexion, tailored to the patient's stiffness pattern, alongside a once-weekly supervised therapy session.
Intervention: Static Progressive Splinting for Persistent Wrist Stiffness (Behavioral)
Outcomes
Primary Outcomes
Wrist Active and Passive Range of Motion (AROM/PROM)
Time Frame: Assessed at baseline, 6 weeks (post-intervention), and 3 months follow-up.
Measured using a standard goniometer, improvements in wrist flexion and extension (in degrees) are the primary indicators of treatment efficacy.
Secondary Outcomes
- Patient-Rated Wrist Evaluation (PRWE)(Assessed at baseline and at 6 weeks post-intervention.)
- Patient Satisfaction(Collected at 6 weeks and 3 months post-intervention.)
- Incidence of Adverse Events(Continuously monitored from baseline to the 3-month follow-up.)