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NCT Number: NCT06913933

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

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.

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Key information

Conditions

Distal Radius Fractures Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Al Hayah University

Cairo, 12311, Egypt

Location status: Recruiting

Location contact

Mohamed ElMeligie, Ph.D

CONTACT

[email protected]

01159880001 ext. +20

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Patient-Rated Wrist Evaluation (PRWE)

    Time frame: Assessed at baseline and at 6 weeks post-intervention.

    The PRWE questionnaire assesses wrist pain and disability, with lower scores indicating better functional status.

  2. Patient Satisfaction

    Time frame: Collected at 6 weeks and 3 months post-intervention.

    A standardized satisfaction survey measuring patients' perceived improvement and overall satisfaction with the orthotic intervention.

  3. Incidence of Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Al Hayah University In Cairo

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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