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

NCT06913933 | Recruiting

• 1 other identifier: SPDS2025-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Study Arms (2)

Static Progressive Splinting Group (SPSG)

EXPERIMENTAL

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

Dynamic Splinting Group (DSG)

EXPERIMENTAL

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

Interventions

Static Progressive Splinting for Persistent Wrist Stiffness BEHAVIORAL

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.

Static Progressive Splinting Group (SPSG)

Dynamic Splinting for Persistent Wrist Stiffness BEHAVIORAL

Materials: A commercially available dynamic (spring-loaded) splint designed for the wrist. An instructional manual and daily usage log for participants.

Dynamic Splinting Group (DSG)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al Hayah University In Cairo: lead

Study Sites (1)

Faculty of Physical Therapy, Al Hayah University

Cairo, 12311, Egypt

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Interventions

Splints

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 6, 2025
• Study Start: April 17, 2025
• Primary Completion: April 17, 2026
• Study Completion: April 17, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)