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Effectiveness of Exercise Relative Motion Orthoses for Limited Finger Joint Motion

NCT06985459 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2025-05-29

No results posted yet for this study

Summary

This randomized controlled trial investigates the effectiveness of two exercise orthosis designs-the Relative Motion Flexion (RMF) and Relative Motion Extension (RME) orthoses-for improving motion in patients with proximal interphalangeal joint (PIPJ) flexion or extension deficits. A total of 148 adult patients with acute hand injuries and a minimum 10° difference between active and passive PIP joint motion will be enrolled. Participants are stratified by their primary motion deficit and randomized to either the exercise orthosis or placebo orthosis group. The orthosis is worn for 4 weeks, with follow-up assessments at weeks 6 and 8 to evaluate range of motion and patient satisfaction. All participants will continue standard hand therapy throughout the study.

Conditions

  • Proximal Interphalangeal Joint Stiffness

Interventions

DEVICE

PIP extension deficit treated with an exercise RMF orthosis

The RM orthoses will be worn between 6-12 hours per day during functional use.

DEVICE

PIP extension deficit treated with a placebo RMF orthosis

The placebo orthosis has the same design as the exercise RM orthoses, but without a difference in the extension or flexion angle, respectively, to the adjacent finger - therefore neutralizing the "quadriga phenomena", which is the effect that makes RM orthoses work.

DEVICE

PIP flexion deficits treated with a placebo RMF orthosis

The placebo orthosis have the same design as the exercise RM orthoses, but without a difference in the extension or flexion angle, respectively, to the adjacent finger - therefore neutralizing the "quadriga phenomena", which is the effect that makes RM orthoses work.

DEVICE

PIP flexion deficits treated with an exercise RME orthosis

The dedicated orthosis wearing time is 6-12 hours per day during functional use.

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2028-05-31
Completion
2028-05-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06985459 on ClinicalTrials.gov