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

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 Overview

• Status: Recruiting
• Conditions: Distal Radius Fractures
• Intervention / Treatment: Behavioral: Static Progressive Splinting for Persistent Wrist Stiffness; Behavioral: Dynamic Splinting for Persistent Wrist Stiffness

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12311
    • Recruiting
    • Faculty of Physical Therapy, Al Hayah University
    • Contact: Mohamed ElMeligie, Ph.D; Phone Number: +20 01159880001; Email: mohamed.elmeligie@ahuc.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrist Active and Passive Range of Motion (AROM/PROM)	Measured using a standard goniometer, improvements in wrist flexion and extension (in degrees) are the primary indicators of treatment efficacy.	Assessed at baseline, 6 weeks (post-intervention), and 3 months follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Rated Wrist Evaluation (PRWE)	The PRWE questionnaire assesses wrist pain and disability, with lower scores indicating better functional status.	Assessed at baseline and at 6 weeks post-intervention.
Patient Satisfaction	A standardized satisfaction survey measuring patients' perceived improvement and overall satisfaction with the orthotic intervention.	Collected at 6 weeks and 3 months post-intervention.
Incidence of Adverse Events	Incidence and severity of adverse events such as skin breakdown, discomfort, or pain (≥4/10) associated with splint usage.	Continuously monitored from baseline to the 3-month follow-up.

Collaborators and Investigators

• Sponsor: Al Hayah University In Cairo

Study record dates

Study Major Dates

• Study Start (Estimated): April 17, 2025
• Primary Completion (Estimated): April 17, 2026
• Study Completion (Estimated): April 17, 2026

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Arm Injuries; Forearm Injuries; Wrist Injuries; Wrist Fractures; Radius Fractures
• Other Study ID Numbers: SPDS2025-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No