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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-17

Study Completion Date

2026-04-17

Brief Summary

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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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Detailed Description

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Conditions

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Distal Radius Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Static Progressive Splinting for Persistent Wrist Stiffness

Intervention Type 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 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.

Group Type EXPERIMENTAL

Dynamic Splinting for Persistent Wrist Stiffness

Intervention Type BEHAVIORAL

Materials:

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No