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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAl Hayah University In Cairo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Static Progressive Splinting Group (SPSG)Experimental treatment 1 intervention
Group B: Dynamic Splinting Group (DSG)Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
Assessed at baseline, 6 weeks (post-intervention), and 3 months follow-up.

Secondary outcomes

1

Patient-Rated Wrist Evaluation (PRWE)

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

Time frame
Assessed at baseline and at 6 weeks post-intervention.
2

Patient Satisfaction

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

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

Incidence of Adverse Events

Incidence and severity of adverse events such as skin breakdown, discomfort, or pain (≥4/10) associated with splint usage.

Time frame
Continuously monitored from baseline to the 3-month follow-up.

Other outcomes

Sponsors and contacts

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