Distal Radius Fractures
Conditions
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.
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.
Sponsors
Al Hayah University In Cairo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants will be randomized into two parallel arms. One arm will receive a static progressive splint, and the other a dynamic splint, each used in addition to a weekly supervised therapy session. The splints are used to address persistent ROM limitations after conventional therapy has plateaued.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wrist Active and Passive Range of Motion (AROM/PROM) | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient-Rated Wrist Evaluation (PRWE) | Assessed at baseline and at 6 weeks post-intervention. | The PRWE questionnaire assesses wrist pain and disability, with lower scores indicating better functional status. |
| Patient Satisfaction | Collected at 6 weeks and 3 months post-intervention. | A standardized satisfaction survey measuring patients' perceived improvement and overall satisfaction with the orthotic intervention. |
| Incidence of Adverse Events | Continuously monitored from baseline to the 3-month follow-up. | Incidence and severity of adverse events such as skin breakdown, discomfort, or pain (≥4/10) associated with splint usage. |
Countries
Egypt
Outcome results
None listed